UK Government cancelled its order of Valneva's VLA2001 citing violation while company denies.
deal with Genentech for its cancer-targeted allogeneic T-cell therapies for $150M upfront, $150M in 5y, and upto $3B in milestones.
Eli Lily license its Axiomer RNA editing platform for $50M upfront and up to $1.25B in milestones.
Kadmon ROCK inhibitor buyout by $SNY Sanofi, not much gain since IPO
down -41% on interim Ph1 data Upifitamab Rilsodotin (UpRi/ XMT-1536) for ovarian cancer. 2/75 CR, 17/75 ORR, 43/97 TRAE.
raise $20M at market price
Ph1/2 BMN 307 an AAV5-phenylalanine hydroxylase (PAH) gene therapy to treat phenylketonuria (PKU) on clinical hold. FDA’s decision was based on a pre-clinical, non-GLP pharmacology study, and safety concerns that arose from the trial.
IV Empaveli (pegcetacoplan, complement C3 inhibitor) for geographic atrophy (GA, a type of wet AMD) met endpts in one of two Ph3 trials. Miss the other one. -37%
Up 5% on patent win speculation. USPTO awarded another LNP patent.
AC Immune announce Ph2 semorinemab (anti-Tau antibody) for Alzheimer AD. Met one of two primary endpoint. to present at CTAD.
to discontinue ABI-H2158 due to drug-induced hepatotoxicity. One of three Beigene deal compounds.
Pliant Therapeutics 2020 IPO, 52w peak $40, now $19, lead product candidate, PLN-74809, is an oral, small molecule, dual-selective inhibitor of αvβ6 and αvβ1 for idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC).
to discontinue FB-401 for atopic dermatitis. FB-401, consists of three therapeutic strains of a commensal gram-negative bacteria, Roseomonas mucosa that were specifically selected for their impact on key parameters of inflammatory skin disease.
Trudhesa (dihydroergotamine mesylate) is a nasally administered dihydroergotamine (DHE) formulation. FDA approval for acute treatment of migraine.
3rd dose induce 40X Ab against delta variant, submit to FDA, Belgian research shows Moderna titer 2X of Pfizer/BioNtech
EU says '069 patent is valid
acquired by $PFE for CD47 assets $2.26B $18.5 per share 118% premium to 60d MA. Lower than $21 52wk peak.
Theravance gut specific pan-JAK inhibitor izencitinib for ulcerative colitis failed Ph2b trial. Tofacitinib systemic inhibitor already approved for the indication. 2014 IPO, I never recorded a single item here at biolog. Mediocre stock performance.
TransCon hGH approved. SKYTROFA (lonapegsomatropin-tcgd). first once-weekly treatment for pediatric growth hormone deficiency. $OPK competitor, IPO in 2015, never dropped too low. IPO $20 Low $12 Peak 185 now $155. 9X
delayed decision on AXS-05 NDA for MDD, previously "identified deficiencies". Requested no additional information. Up 11%, probably will CRL like $DVAX delays.
FDA approved Korsuva for moderate-to-severe pruritus 瘙痒 associated with chronic kidney disease in adults undergoing hemodialysis.
Citizen Petition to halt Ph2 and pending Ph3 trial until data audit complete regarding allegations of false or misleading data in its Alzheimer’s trials. FDA only commented it received petition. $SAVA named Quanterix as the company generated results in question. Quanterix refuted claims that they only collected the data, didnot do analysis for AAIC meeting. $SAVA confirmed that in a later release.
Stock down 44%.
COVID vaccine fully approved. sBLA for booster dose to submit end of week.
release interim Ph1 data of FT516 FT596 NK therapy combo w. rituximab for r/r B lymphoma. durability concern.
Sparsentan is a first-in-class, orally active, single molecule that functions as a high affinity dual-acting antagonist of both endothelin type A (ETA) and angiotensin II subtype 1 (AT1) receptors which are associated with kidney disease progression.
following CRL news, a further 12-month confirmatory trial is also required with a BLA to be resubmitted in 2023 at the earliest.
deal with telehealth company, Pandia Health for marketing and sales
Medigen rolls out vaccine with only Phase 2 results. "political will".
forbes article on LNP tech patent https://www.forbes.com/sites/nathanvardi/2021/08/17/covids-forgotten-hero-the-untold-story-of-the-scientist-whose-breakthrough-made-the-vaccines-possible/
2021 IPO, Lomecel-B Ph2b for Aging Fraility Day 180 not significant in 6MWT. Day 270 is significant but not primary endpoint.
positive interim Ph1 results FTX-6058 for sickle cell disease, proof of mechanism. +184%.
another SUSAR of MDS in a eli-cel (Lenti-D) treated patient in Ph3 trial for cerebral adrenoleukodystrophy (CALD). FDA clinical hold. Company also winding down operations in Europe for its severe genetic disease business to focus on US. Was $232 in 2018, now $18
Cortexyme 2019 IPO, Ph3 Alzheimer data due mid-Nov 2021, narrowing from 4Q21, up 49%. Burst with data? Atuzaginstat (COR388) / Lysine gingipain (protease) inhibitor
CRL for roxadustat for anemia of chronic kidney disease (CKD). Previous AdCom fiasco. FDA requested additional trial.
update NDA bardoxolone for chronic kidney disease caused by Alport syndrome. FDA has identified four significant clinical and statistical review issues for the company to address. AdCom 12/8/21, PDUFA 2/25/22
FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments of its AXS-05 NDA for MDD. No details. NMDA receptor antagonist with multimodal activity under development for the treatment of CNS disorders.
FDA CRL on Vicinium ADC for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). FDA noted clinical/statistical data and analyses plus CMC issues.
Q2 sales 0.4M
acquires by $SNY, 2X since IPO, uses LNP $ABUS
reports Ph2 data nedosiran, once-monthly for primary hyperoxaluria (PH). While significant in PH1, not so in PH2, which is more important.
ROLONTIS (eflapegrastim) CRL due to CMC issues. RE-inspection required. was delayed due to pandemic.
BeyondSpring Pharma 2017 IPO founded 2010. Plinabulin BPI-2358 combo docetaxel Ph3 success for 2nd and 3rd line NSCLC (non small lung cancer). OS, PFS, and marked reduction of Grade 4 neutropenia.
In trial Alzheimer's and Parkinson’s disease, placebo saw improved cognitive impairment compared with Posiphen ANVS-401. -71%. Other AAIC presenters such as $SAVA also sold off. used to be Y+300%.
big earnings increase devoted to the development and production of materials used in the manufacture of biological drugs. Used to have a diagnostic drug for PSIC study. Now 7X in 5 years.
Infinity released eganelisib PI3K-gamma in Ph2 Urothelial Cancer (UC) and Triple Negative Breast Cancer (TNBC). 2X PFS in UC, less in TNBC. Analyst worried competition from similar MOA, orPD-1 and Cellular therapy (CAR-T etc.) and commercial potential due to small target population. Some speculate not directly comparable to Roche trial. Expect NDA for UC, but not positive for TNBC.
FDA Grants Breakthrough Device Designation Status for Hancock Jaffe's VenoValve. Share price spike and burst, not sustained.
Q2 Total Rx up 171% New Rx 103% Refill up 355%.
Q2 Heplisav revenue 13.7 mil (30% ) vs 8.3 (27%) in previous quarter. Total revenue down due to fluctuation in CpG trial revenue.
-22% ATRC-101 anti-tumor-specific ribonucleoprotein (RNP) complex. 8/20 Stable Disease.
Down 31% on CRL sulopenem for uUTI, need additional trial, previously up 25% on "no need for AdCom"
to pay $35m to settle an opioid-related case involving counties and cities in Tennessee vs $2B initially sought. up 41% to $5.
TNX-102 SL for fibromyalgia stop Ph3 enrollment due to IDMC futility.
TNX-102 SL is a small, rapidly-disintegrating, under the tongue (sublingual) product candidate containing 2.8 mg of cyclobenzaprine HCl. The unique formulation has been designed to optimize the delivery and absorption of cyclobenzaprine for the therapeutic benefit of improving sleep quality, while minimizing the potential residual effects of oral formulations of cyclobenzaprine. The dose of TNX-102 SL being studied in fibromyalgia is two tablets, or 5.6 mg of cyclobenzaprine each night at bedtime.
MGTA-117 Anti-CD117 (cKit) amanitin ADC FDA clinical hold for Ph1/2 in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
LUM-201 acts as an agonist of the GH Secretagogue Receptor to stimulate GH release for Pediatric Growth Hormone Deficiency (PGHD). increase the amplitude of endogenous pulsatile GH secretion in humans, which mimics the natural pattern of GH secretion. Data now delay to 2H2023. -20%
-64% on SER-287 Ph2 failure for mild-to-moderate ulcerative colitis (UC). Company disappointed not deterred, citing SER-109 C. difficile. Share price back to pre Ph3 success level.
Up 51% week on CK-274 Ph2 success for hypertrophic cardiomyopathy (HCM). See previous 2020 note similar MOA to $MYOK mavacamten. left ventricular outflow tract pressure gradient (LVOT-G) level 92.9% in high dose vs 7.7% placebo.
FDA identified deficiencies in Tenapanor NDA for serum phosphorus control in CKD. FDA noting the size of the treatment effect and its clinical relevance as one of the key issues. -78%
CRL issued the following week. Little price change.
deal with Walmart VAZALORE, an liquid-filled aspirin capsule, available in 4,500+ stores in mid-August. 5X half year, 3.5 year base. This PLxGuard® drug delivery platform is intended to reliably release APIs in the duodenum and decrease exposure to the stomach, which is the most susceptible part of the GI tract to NSAID-induced acute gastric injury.
CohBar, mitochondria company founded by Nir Barzilai, M.D. Pinchas Cohen, M.D. David Sinclair, Ph.D. COHenBARzilai. data release Ph1a/b CB4211 for NASH and obesity delayed from early July to Labor Day. -28%. Low in cash MCap 62M, cash <20M
negative data from 2 of 3 readouts GLPG3970, success signs for psoriasis, failed both rheumatoid arthritis and ulcerative colitis.
AdCom roxadustat for anemia of chronic kidney disease voted 2-12 against approval in patients on dialysis and 1-13 against approval for patients not on dialysis. Previous data scandal. -42% was $56 in Feb now $14
rise due to inclusion in SP500, potential boom and burst
it is interesting that the Company has about 2 quarters of cash at the end of Q1, and was ramping up marketing including TV, so less than 1 quarter of cash by now. Yet no financing announced yet. Debt facility at this cash level or ATM at ~$1 also dangerous.
up 24% on deal with french company Laboratoire Aguettant to receive up to approximately $55 million in combined up-front and sales-based milestone payments for DZUVEO licensing agreement, obtains the rights to file NDAs and commercialize two innovative pre-filled syringe product candidates (ready-to-use ephedrine and phenylephrine) for the U.S.
IP theft can profit big, rose 20x in 2 years. Wait for its Karma crash?
FDA clinical hold on Ph1/2 SIG-001 for hemophilia A after 1 of 3 patients (3rd) developed FVIII inhibitor, common complications in FVIII therapies.
CDX-0159 (KIT inhibitor) continue to succeed in new indications. This time Ph1b open label in antihistamine refractory cold urticaria and symptomatic dermographism. 18/19 (95%) CR 1/19 marked PR.
filed amendment to avacopan (C5aR) NDA addressing AdCom points. delay PDUFA to 10/7/2021.
teplizumab (anti CD3 to prevent T cell attacking beta cells). FDA CRL due to commercial product PK not comparable with clinical trial batch. Data will be ready later this Q, decision after review will be made 1) submit or 2) justify why not necessary.
Microcap+ (>50M) Biotech Belowcash 14:
17 <=1; 134 <=2 (671 biotech); price 129 <=3
Healthcare -95% None -80% 9:
Healthcare 45; Y+500% 15:
min Mcap 3.82B, medium 7.08B
$NVAX lost 13.7% for no reason (CEO sold 55k shares, only 35k left), $DVAX $ABUS among the best COVID index stocks. $DVAX still 3rd place in relative 52wk performance
Ph2a IND approved by FDA, AB-729+NA+IFN. After a 24-week dosing period of AB-729 (60 mg SC every 8 weeks (Q8W)), subjects will be randomized into one of 4 groups:
Biological E. announced commercial agreement with $DVAX extends through 2022
collaboration again with VacciTech AB-729, combo with Immunotherapeutic, VTP-300 for Ph2a HBV who are already receiving standard-of-care nucleos(t)ide reverse transcriptase inhibitor (NrtI) therapy. split all costs. VTP-300 utilizes Vaccitech’s ChAdOx1-HBV/MVA-HBV prime-boost combination to elicit an immune response against HBV.
Ph3 cabozantinib (CABOMETYX) in combination with atezolizumab versus sorafenib in previously untreated advanced hepatocellular carcinoma (HCC). Met PFS endpts, interim OS data shows unlikely to meet at early 2022 final analysis. -22% week.
CEL-SCI Ph3 Multikine (injection of 14 cytokines) for HNSCC fails. -68% week.
2020.10 IPO Cerevel. Rick neurology pipeline. CVL-231 Ph1 success for schizophrenia. In the 30 mg cohort, scores in the Positive and Negative Syndrome Scale (PANSS) were a statistically significant and clinically meaningful 19.5 points lower than baseline and 12.7 points lower than the placebo group (p=0.023). Ph1 is early.
FDA identified deficiencies that preclude the discussion of labeling and post marketing requirements/commitments for its NDA for sulopenem. -38%. Previously note up 27% when FDA deemed AdCom no longer necessary.
NexoBrid™ contains a mixture of enzymes called “concentrate of proteolytic enzymes enriched in bromelain”, which is extracted from the stem of the pineapple plant. It removes the eschar without harming viable tissue, in the majority of cases, after only a single 4-hour topical application at the patients’ bedside.
its Fc-engineered antibody report results. A single dose only last a few days, then let go normally. It cannot cure the disease like in other model and experiment design. $ABUS I was worry about RNAi got out compete. It turns out fine. Negative expectation turned out OK.
reports first-ever clinical data supporting safety and efficacy of in vivo CRISPR genome editing in humans. Interim readout in ongoing Ph1 trial finds single 0.3 mg/kg dose of NTLA-2001 led to 87% mean reduction in serum TTR for transthyretin (ATTR) amyloidosis, with a maximum 96% serum TTR reduction by day 28, with dose-dependent response. Compete with $ALNY. May use $ABUS LNP patent
to discontinue nasal spray COVID vaccine and treatment pipelines.
EASL ILC five abstract, all "Best of ILC". New AB-729 data showing a same plateau after 20 weeks regardless of dose or interval. Will choose 60mg Q8W for Ph2a. 75% (15/20) <100IU/ml, ALT/AST resolvable after continued dosing. $ARWR ARO-HBV (JNJ-3989) 88% (n=40) 43% <10 13% <1 IU/ml.
collaboration with Antios Therapeutics to combo AB-729 with its proprietary active site polymerase inhibitor nucleotide (ASPIN), ATI-2173, and Viread in a Ph2a single cohort.
Alora Pharmaceuticals, LLC to acquire its legacy products and its Marietta, Georgia manufacturing facility, for up to $170 million
cinrebafusp alfa PRS-343 (see previous note for MOA) orphan drug designation for HER2-high and HER2-low expressing gastric cancers. Ph2 to start summer.
TP-03 success Ph2b/3 for Demodex blepharitis 螨虫性睑缘炎 orphan disease. statistically significant reduction in collarette (cylindrical dandruff), compared to vehicle (p<0.0001). TP-03 designed to paralyze and eradicate mites and other parasites through the inhibition of parasite-specific GABA-Cl channels. sell off on news. Had run 3X.
2020.08 IPO -40% on Ph2a failure GEM103 in geographic atrophy (GA) secondary to dry AMD. indistinguishable to placebo.
a recombinant form of the human complement factor H protein (“CFH”), and is designed to address both complement hyperactivity and restore retinal health in patients with AMD
TIGIT immunotherapy, domvanalimab, has shown encouraging clinical activity in Ph2. No details.
FDA awarded Breakthrough Therapy designation for donanemab Alzheimer's Disease. aka N3pG, is a humanized IgG1 monoclonal antibody developed from mouse mE8-IgG2a. This biologic drug recognizes Aβ(p3-42), a pyroglutamate form of Aβ that is aggregated in amyloid plaques. Most Aβ antibodies in therapeutic development bind various soluble or insoluble species but have low affinity to deposited amyloid plaques. The rationale behind donanemab is that targeting deposited plaque itself is necessary to clear existing amyloid burden from the brain, rather than merely prevent deposition of new plaques or growth of existing plaques. Some previous plaque-binding antibodies have been abandoned because they caused microhemorrhages in the brain. The mE8 antibody was reported to clear plaques in mice without causing microhemorrhages.
intravenous (IV) tramadol received 2nd CRL. The CRL stated that the delayed and unpredictable onset of analgesia with IV tramadol does not support its benefit as a monotherapy to treat patients in acute pain, and there is insufficient information to support that IV tramadol in combination with other analgesics is safe and effective for the intended patient population.
down 50% FDA CRL for arimoclomol (amplifies heat shock proteins HSPs) in Niemann-Pick disease type C (NPC), previously failed ALS. Licensed from $CYTR. also down 62%
CRL based on needing additional qualitative and quantitative evidence to further substantiate the validity and interpretation of the 5-domain NPC Clinical Severity Scale (NPCCSS) and, in particular, the swallow domain. Further, the FDA noted in the CRL that additional data are needed to bolster confirmatory evidence beyond the single phase 2/3 clinical trial to support the benefit-risk assessment of the NDA
Ph1/2a open-label CLS-AX (axitinib broad VEGF inhibitor injectable suspension) in six patients with neovascular age-related macular degeneration (wet AMD). One month after receiving CLS-AX, five of six patients exhibited improvement in the best corrected visual acuity (BCVA) score, each gaining four or more letters, with mean score of all patients increasing by +4.7 letters (p=0.029).
Had two long flat base since Xipere failure.
zuranolone (SAGE-217/BIIB125) 50 mg for major depressive disorder showing statistically significant improvement in depressive symptoms compared with placebo at Day 15. Market still worry its durability. -28% week.
Ph1b RPT193 another CCR4 small molecule antagonist, that blocks the recruitment of inflammatory immune cells, known as Th2 cells, which are clinically implicated in allergic inflammatory disorders.
Clover announced commercial agreement with $DVAX and COVAX pre-order of 414M doses.
its unmodified mRNA vaccine (3'-UTR engineered) how only 47% in Ph2/3 trial. -37%. Still a 10B+ large cap.
release US Ph3 results. 90.4% efficacy, 100% protection against moderate and severe disease. 93.2% against VOC. sell off 17%
Feb: 4 posts Mar: 2 Apr:1 May: 0 被人遗忘
7X since 2020.3, 15month.
The Autolus program, known as 0be-cel, achieved a 100% complete remission rate in a cohort of indolent B Cell Non-Hodgkin lymphoma patients, with all nine treated patients hitting the mark as of the May 17 cutoff. Another three patients are still awaiting treatment, while a fourth enrolled individual died due to a Covid-19 infection.
Flt3/BTK inhibitor new data fails to impress at EHA, I did not fully understand details. Could be sell off on news.
IRAK-4 inhibitor EHA data release , selecting low dose for Ph2 due to safety concerns, sell off big after 7 fold run.
reports SB-206 Ph3 success molluscum contagiosum. Previous failed. No adverse event and to NDA by 3Q22.
VX-864 small molecule Alpha-1 proteinase inhibitor for alpha-1 antitrypsin deficiency (AATD) Ph2 failure, to discontinue. RNAi competitors have better results. $ARWR $DRNA $ALNY Previous VX-814 failed.
Lyra Therapeutics, 2020.05 IPO, FDA agrees on LYR210 trial design for chronic rhinosinusitis CRS. The single primary endpoint will evaluate improvement at week 24 using a composite score of three cardinal symptoms (3CS) of CRS: nasal blockage, nasal discharge, and facial pain.
no more EUA, will go through BLA.
aducanumab approved against AdCom, 3/11 member resigned, FDA ask confirmatory trial complete by 2029.08, data by 2030. at least 9 years of sales. annual cost $56,000
MorphoSys acquire Constellation Pharmaceuticals $CNST for $1.7B, 71% premium. $CNST 200% return since 2018 IPO. $MOR mediocre performance since 2018 IPO.
previous CMC CRL, release Ph3 data. pegunigalsidase alfa (PRX–102) for Fabry disease miss changes in eGFR when compared with agalsidase beta (Fabrazyme), were below the non-inferiority margin pre-specified for the interim analysis in ITT. eGFR, or Estimated glomerular filtration rate, measures the level of kidney function. The company also noted that one patient discontinued due a related treatment emergent adverse event.
After CRL, Alkermes Wins FDA Approval for Schizophrenia Drug Lybalvi ALKS-3831, previous CMC CRL. little price move.
through its affiliate QED Therapeutics Inc and Helsinn Group, FDA accelerated approval Truseltiq (infigratinib) forcholangiocarcinoma (CCA) with previously treated locally advanced or metastatic CCA harboring an FGFR2 fusion or rearrangement. Truseltiq is an orally administered, ATP-competitive, tyrosine kinase inhibitor of FGFR. The approval of Truseltiq is based on Ph2 results.
FDA Approval for TEMBEXA® (brincidofovir) for Smallpox. First product. a prodrug of cidofovir. Conjugated to a lipid, the compound is designed to release cidofovir intracellularly, allowing for higher intracellular and lower plasma concentrations of cidofovir, effectively increasing its activity against dsDNA viruses, as well as oral bioavailability.
was #BelowCash. up 17% to $9.60 FDA approved sNDA for oral-only dosing regimen of NUZYRA for Community-Acquired Bacterial Pneumonia (CABP).
Scynexis FDA approved BREXAFEMME (ibrexafungerp tablets) for vulvovaginal candidiasis (VVC), aka vaginal yeast infection. Sold on news. SCY-078 a broad-spectrum, IV/oral antifungal agent, the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids.
Liminal BioSciences FDA approved Ryplazim (plasminogen replacement therapy) for plasminogen deficiency type 1 (hypoplasminogenia)., the first FDA approved therapy for this rare genetic disorder. Up 55% AH.
PDUFA coming next week, trigger for new biotech bull?
5 abstracts at EASL
For its indigenously developed vaccine, Biological E has sought funding support from the government for at-risk manufacturing, essentially for the import of adjuvant which is in "high demand" in the international market.
FDA CRL for dehydrated alcohol injection for the treatment of methanol poisoning due to COVID restriction prevented a Pre-Approval Inspection (PAI) of its European contract manufacturer. -17%
FDA deem previously postponed AdCom no longer necessary, now working toward PDUFA 7/25/2021 up 27%. Isn't bad sign?
2015 IPO Lantheus, we are dedicated to the development, manufacture and commercialization of innovative diagnostic imaging agents, targeted therapeutics, and artificial intelligence to find, fight, and follow disease. IPO: "a global leader in developing, manufacturing, selling and distributing innovative diagnostic imaging agents and products".
FDA AdCom on teplizumab voted 10-7 benefit outweighs risk to delay type I diabetes. volatile yet ended flat. FDA required data a few days ago.
Larimar Therapeutics CTI-1601 is a recombinant fusion protein intended to deliver human frataxin into the mitochondria of patients with Friedreich’s ataxia (FA) $RETA. which is the cause of the disease. FDA clinical hold after NHP toxicology study show mortality.
Versamune HPV16 for HPV16+ cancer news continue to push stock up +75% week
Genentech licensed its Anticalin tech for respiratory and ophthalmology therapies, $20M upfront upto 1.4B milestones
1:10 reverse split, -40% afterwards
licensed Heplisav-B to Bavarian Nordic for Germany.
nature summarizes COVID-19 mRNA vaccine patent network.
CEO CFO both bought 20K shares in May 2021
flat 5-year chart. deal with $BMY foe AGEN1777 pre-clinical TIGIT bi-specific antibody, $200M upfront + upto $1.36B milestones.
2017 IPO reverse merger with Aadi Bioscience, Inc, precision therapies for genetically-defined cancers.
reverse merger IPO with $EDGE in 2019, below $1 in 2020, back to $9 after ASCO abstract release. "Biggest winner."
2020.01 IPO $6 now $56 with $98 intraday peak. ANVS401 Ph2 Alzheimer's Disease AD Success, 25 days show statistically significant cognitive improvement as measured by an 11-part test.
peaked at 54 in 2021.02 market peak, now at $18 after announcing BLA for lifileucel (tumor infiltrating lymphocytes) delayed from 2021 to 1H22 due to FDA feedback on submitted assay data.
FDA ask company to withdraw type C meeting and request pre-NDA meeting on Omaveloxolone for Friedreich's Ataxia.
Narsoplimab OMS721 is a human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system. The lectin pathway is one of the principal pathways of complement and is activated primarily by tissue damage and microbial infection. Importantly, inhibition of MASP-2 does not appear to interfere with the classical complement pathway, a critical component of the acquired immune response to infection. This novel, proprietary drug is designed to prevent complement-mediated inflammation and endothelial damage while leaving intact the respective functions of the other pathways of innate immunity.
Begin manufacturing, EUA by July. More revenue for DVAX.
2021.05 8th Tampa-USF for patients with sickle cell disease presenting to the emergency department (ED) with painful vaso-occlusive crisis (VOC).
Investigator from Montefiore Medical Center and Albert Einstein College of Medicine.
clover announce pre-clinical data for next generation booster. Adjuvant is not necessary. numerically 1.7-2.4x less titer. So still better with adjuvant.
1Q21 CC: only 0.5 million revenue. Where are military revenue? CEO says COVID impact easing, April best commercial revenue since launch
Clover Health, SPAC deal 2020, false claim of subscribers in SPAC deck
nature communication showing ACAT inhibitor inhibit HBV DNA and HBsAg in vitro. But clinical trial have shown CV risk
Ginkgo Bioworks grabs $DNA ticker in a SPAC deal
FDA approved Empaveli (pegcetacoplan, complement C3 inhibitor) injection for paroxysmal nocturnal hemoglobinuria (PNH). REMS program required.
sell off 17% on FDA approval ZYNRELEF (HTX-011, bupivacaine and meloxicam) post-operative pain management for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.
additional work to address CRL, resubmit plan 4Q21
more data on IRAK-4 success: BM blast reduction in 8/9. 1 complete recovery, 1 CRi, 2 BM CR.
Autolus 2018.06 IPO. EHA abstract Ph1 cell therapy candidate, AUTO1, 100% remission rate in relapsed/refractory indolent non-Hodgkin lymphoma. n=9
Island reversal. I speculate that FDA will reject Matrix-M adjuvant. It won't be easy to get a new adjuvant pass FDA $DVAX
propose to issue $200M convertible unsecured notes to pay off existing CRG loan. -20% to close gap at $6.75
Athenex acquired Kuur Therapeutics, Inc., a developer of off-the-shelf CAR-NKT cell immunotherapies for the treatment of solid and hematological malignancies. 70M upfront + up to $115M in milestone.
all stock combination with Amryt $AMYT. Close at $4. to own 40% of new co.
Ph2 results monthly dose of SRP-5051 30mg/kg produced 8x (6.55% v. 0.86%) dystrophin as weekly dose of Exondys 51, its current approved drug for DMD.
-33% Ph3 fail arimoclomol (amplifies heat shock proteins HSPs) in amyotrophic lateral sclerosis (ALS). See previous note for IBM. Original license seller CytRx $CYTR also fall 21%
AVR-RD-01 ex vivo lentiviral gene therapy agalsidase beta no longer eligible for accelerated approval due to the approval of agalsidase beta Fabrazyme from Sanofi Genzyme. lost 80% since 2018 IPO hype.
Ph3 Motixafortide, in combination with G-CSF for hematopoietic stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients, met primary and secondary endpoints. Previously stopped enrollment early in 2020.10 for obvious benefit. Still not too much price action
not to pursue NDA until 1H2022 citing delays in manufacturing, in part caused by the global COVID-19 pandemic.
FDA AdCom split 9-9 on efficacy 10-8 on benefit-risk profile on avacopan for anti-neutrophilic cytoplasmic autoantibody (ANCA)-vasculitis. complement C5aR inhibitor, was 10X. Dive on briefing doc first, then on AdCom vote. Back to where it started.
panic selling upon vaccine IP waiver comment from Biden. Same day reversal. Bottom for Biotech?
both gap filled!
ER: nothing new. Continue to sell ATM.
1Q21 ER: sales small but trending great, double in two months. 280% QoQ growth " the early stage of a parabolic-looking curve". Cash is concerning
Sales (M)/Px (K):
up big on KOL T cell announcement, down after ER, up big AH after KOL event.
twitter argument:Replying to @GuptaBioDD @DudeBiotech and 2 others
Ph2 Korsuva for moderate-to-severe pruritus in mild-to-severe atopic dermatitis (AD) failed primary endpoint of the change from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 12
Korsuva, a peripherally acting kappa opioid receptor (KOR) agonist called difelikefalin. ANti-pruritic and anti-inflammatory, highly specific to kappa receptor
ADVM-022 (AAV.7m8-aflibercept) anti-VEGF gene therapy Ph2 trial for diabetic macular edema (DME) report a Suspected Unexpected Serious Adverse Reaction (SUSAR) of hypotony (decrease in ocular pressure). AAV continues to deliver SUSAR. How many more SAEs and deaths will it take for the gene therapy field to switch to LNP? $ABUS
Was Y+300%, now lost 80% more from 2020 peak.
Ph3 reproxalap for allergic conjunctivitis 过敏性结膜炎 met all endpts. Previous 2019 also Ph3 success.
plant cell based expression for protein biologics. 2006 reverse marger, Pegunigalsidase alfa for Fabry disease FDA CRL due to COVID travel restriction on CMC inspection.
Tenapanor PDUFA extended 3 months, new analyses submission considered major amendment. -13%
EU still in talk with Valneva, 10 states want Valneva's vaccine, fear of prioritize UK. "Conditions not met": "solid protection in the areas of liability safety, effectiveness of the vaccine and also solid rules and arrangements for the delivery of the vaccines."
my fear about safety Ph4 trial and 20% drop turn out fine. Control your fear believe in science and doing of companies, and big picture chart.
Epsolay NDA unable to complete since a pre-approval inspection of the production site of EPSOLAY (benzoyl peroxide 5% topical cream for Inflammatory lesions of rosacea) still needs to be conducted.
MELAS trial enrollment slow, results delayed to YE21. ADv IND approved, to initiate by Mid2021. CY3018 better brain to blood ratio, working on IND.
CpG1018 is safer(!) than Alum. $DVAX has the safest vaccine adjuvant in the world: SAE: Heplisav 1.5% v. Engerix 2.1%; AMI 1.67 v 1.86; Fever 1.3% x2 doses v. 1.8% x3.
Clover switched to $DVAX because $GSK unable to provide adjuvant due to political pressure.
Ph1 data SNDX-5613 in mixed lineage leukemia rearranged (MLLr) and nucleophosmin (NPM1c) mutant relapsed/refractory (R/R) acute leukemias. 48% ORR (15/31). Stock down -24% due to only 5 CR. Previosuly (2020.05) 2/3 ORR 1PR1CR.
1Q21 fell 24%. All eyes on Aducanumab for AD due PDUFA 2021.06.07
will it announce co-promotion in the USA?
FDA halt the manufacture of the Johnson & Johnson COVID-19 vaccine at one of its main plants. Horrible management reported.
partner, Bharat Biotech, 2ns interim analysis shows 78% efficacy, 100% against severe disease. 45% profit in US market. +67%
withdraw US government funding, citing increasing number of EUA in the US, still plan to initiate Ph3 outside of US. down 25%
BiologicalE has finished Ph1/2 after 2 month delay, will submit data in the next days and start Ph3 soon. Ready in August. That is really fast!
04.24 official news out the next day. "The Phase III clinical study to be conducted in 15 sites across India will evaluate the Immunogenicity and Safety of Biological E’s SARS-CoV-2 COVID-19 vaccine for protection against COVID-19 disease in about 1268 healthy subjects in the age range of 18 to 80 years. It is intended to be part of a larger global Phase III study."@PeterHotez, data out hopefully soon
Valneva enters Ph3. this pivotal phase 3 is much smaller, 4000 enrollment. It is also a comparative trial against $AZN. Is this the first comparative COVID Ph3? AFAIK. Salute to UK regulators.
Genevant new LNP deal with Korean ST Pharm on mRNA vaccine, up to $133M in milestones
-20% shake out on no news, overwhelmingly bullish odds https://wallstreetodds.com/DVAX/#sameday
Valneva Switches Focus to Bilateral Discussions to Supply its Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001, could not get deal with EU. The enthusiasm of UK and lukewarm of EU are in sharp contrast.
two abstract accepted: one for end-stage renal disease (ESRD) who are undergoing hemodialysis, the other Ph4 safety study for Annual Conference for Vaccinology Research (ACVR)
use physics Tumor Treating Fields (TTFields) to treat cancer. report Ph3 success in NSCLC. Interim analysis enrollment can be reduced, save one year completion time. +60% week. China right owner $ZLAB up 24%
FDA is still reviewing its New Drug Application (NDA) for IV tramadol, passed PDUFA. -34% week. parent $FBIO -24%
EU 50M more -> 250M total deal, potential 1.8B doses more deal from 2021 to 2023 $PFE, $DVAX
up on no news, good
a doctor at newtalk claim valneva may be the best at variant.
Celcuity 2017 IPO use impedance to measure cell signaling for cancer biomarker. BioMarker - LDT/CDx - Targeted therapy. Very similar to us. First product CELLSignia Test measures HER2/cMET/PI3K, now reports Ph1b success 53/88 60% ORR.
reports data Ph1 cord blood-derived natural killer (cbNK) cells with its innate cell engager (ICE) AFM13 (CD16A/CD30) in recurrent/refractory CD30-positive lymphomas. 4 patients 2 CR 2 PR 100% ORR @Dirk heavy in
CRL Nuplazid sNDA for hallucinations and delusions associated with dementia-related psychosis (DRP). Lack of efficacy evidence.
FDA approved Qelbree SPN-812 for ADHD, another ADHD drug!
FDA identified deficiencies with BLA teplizumab for the delay or prevention of clinical Type 1 diabetes. FDA found that data from two drugs compared in its PK/PD trial to be not comparable and that additional data would be required. AdCom still on track.
down 48% to $18.57 following a disclosure regarding its anemia treatment, roxadustat, in chronic kidney disease. as it was preparing for AdCom meeting NDA, it realize their analysis had included altered data to make the treatment appear safer than it was. Now it cannot conclude that roxadustat reduces the risk of (or is superior to) MACE+ (Major Adverse Cardiovascular Events) in dialysis, and MACE and MACE+ in incident dialysis compared to epoetin-alfa. begun an internal review to ensure such issues do not occur in the future.
AAV, AdV, inject large amount of live virus directly into human body, not natural infection dose and route. How many more SAEs and lives will perish until we abandon AAV and switch to LNP? #CovidVaccine $AZN $JNJ #CanSinoBIO $ABUS #GeneTherapy
The temporal relationship is strong, it’s not seen with mRNA vaccines, and there’s a plausible mechanism analogous to heparin-induced thrombocytopenia (HIT)
It is always sobering to see a shell company like $OCGN has higher market cap then a company $DVAX with an approved product, providing adjuvant to five #CovidVaccine candidates, and a pipeline of other vaccines.
$VLA reported data. Market reaction small. Priced in. No surprise.
FDA IDE approval to begin VenoValve trial in US. Still no share price rise.
hepatic chemo injection system. filter out drug in blood before returning it to patient. PH3 HEPZATO KIT for liver dominant metastatic ocular melanoma (mOM). 29% (95% Cl%: 20.1, 39.8) ORR vs. predefined goal of 21% disappointing.
BXCL501 Selective α2a Adrenergic Receptor Agonist for opioid withdrawal symptoms met primary but miss secondary. -13%
discontinue WVE-120102 and WVE-120101 for Huntington's disease due to lack of efficacy.
Denmark company founded 2009. 2020.09 NASDAQ IPO. Fail Ph2/3 arimoclomol (amplifies heat shock proteins HSPs) for inclusion body myositis (IBM) .
$JNJ vaccine manufacture failure, wasting up to 15mil doses. NYTimes reports ingradients mixed up between $JNJ and $AZN vaccines.
failed again Ph2b Yeast derived MS1819 lipase in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI).
COVID anti-GM-CSF Lenzilumab Ph3 54% greater chance of survival. $KNSA
FDA approved Tyvaso (treprostinil) Inhalation Solution for pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. It is a prostaglandin inhibitor, already approved in 2002 and 2009. See Wikipedia
deal with X-Chem (DNA-tagged small molecule library for high through put screening), Proteros Biostructures on nsp5 main protease Mpro. to combine with assets arising from internal nucleoside program targeting the SARS-CoV-2 nsp12 viral polymerase
Serum Institute of India Ph1 COVID vaccine HSbAg VLP SpyTag/SpyCatcher candidate not in PPT of February
Aptose CG-806 luxeptinib, the only Flt3/BTK dual inhibitor reported a CR in Ph1 R/R AML. Also in B malignancies CLL and NHL.
2019 IPO from MIT, progenitor cell activation learned from intestinal progenitor cells and apply to hearing.
up 45% Ph1/2 QR-421a (exon 13 skipping USH2A) in Usher syndrome and non-syndromic retinitis pigmentosa (nsRP). n=14, 6 letters improvement at week 48 in the treated eyes compared to untreated after a single injection. Down big since 2018 notes.
Roche RHHBY and Ionis announced discontinuation of Ph3 trial of tominersen (huntingtin (HTT) protein antisense) in Huntington's Disease (HD) after IDMC review. $IONS down 21%. Flat for 7 years!
FDA says data to date would likely not be sufficient for FDA approval. discontinue development tesetaxel, winding down company
CMO departure and join clinical advisory board. Chris Wright MD PhD, Harvard Neurology, relevant to current diseases. People on twitter pointed out $ACRS assembled clinical advisory board before "stellar data"
$50M ATM offering, CEO CFO insider buy 62.5k shares at $2, similar to $ACRX, rise may be far away.
Clover doses first patient global Ph2/3 trial, will enroll 22,000 in latin America, Europe, Africa and Asia. Interim read mid Y21
$PFE going alone on mRNA medicine mostly vaccines. Shameless: “We are the best positioned company right now to take it to the next step because of our size and our expertise." ... "He said the company’s scientists and engineers gained a decade’s worth of experience in the past year."
Genevant licenses LNP exclusively to Takeda for "historically inaccessible" Hepatic Stellate Cells, liver fibrosis. No stock response
donanemab (anti-Amyloid-beta) Alzheimer's disease falling short of investor expectations.
2020.07 IPO via SPAC, TCR-T. Ph1 initial success 9/10 SD 8/10 Tumor shrinkage 1PR. me not impressed. Stock up 30%.
MRT5005 LNP+mRNA 2nd interim analysis Ph1/2 cystic fibrosis (CF) exhibited no lung function increase by ppFEV1. $ABUS
$DVAX CpG competitor Ph3 tilsotolimod + ipilimumab CTLA-4 versus ipilimumab alone for anti-PD-1 refractory advanced melanoma, fail ORR. An ORR of 8.8% for combo versus 8.6% for ipilimumab alone.
RTX-240 is an allogeneic, off-the-shelf cellular therapy product candidate that is designed to simultaneously present hundreds of thousands of copies of the costimulatory molecule 4-1BB ligand (4-1BBL) and IL-15TP (trans-presentation of IL-15 on IL-15Rα) in their native forms. RTX-240 is expected to broadly stimulate the immune system by activating and expanding both NK and memory T cells to generate a potent anti-tumor response.
Reports 1PR and 1 unconfirmed PR in hard to treat cold tumor and metastatic tumor patients
IL-1 trap rilonacept Arcalyst approved for recurrent pericarditis
高探生物 高瓴独家投资 三千万 天使轮 TCRT 单细胞测序 实体瘤靶向TCRT
low price drug startup, do not know how
Valneva talking about licensing its vaccine out of Europe
AB-836 IND approved. to initiate Ph1a/Ph1b soon.
CMO leaving company on 4.16. Abandon ship?
AFM13 is a bispecific tetravalent Innate Cell Engager (ICE®) targeting CD30 on tumor cells and CD16A on NK cells and macrophages.
Recent IPO 2020.09, was $38, now $8. GB-102 for wet AMD data release, 9 letter diff than placebo, still disappoints.
imsidolimab (ANB-019) anti-IL36R, failed Ph2 (POC) moderate-to-severe palmoplantar pustulosis (PPP, autoimmune skin disease, IL1 IL36 are dominant cytokines)
announces final UK data, 96% original strain, 86% UK variant, 49% in SA (down), 55% in HIV-.
$GSK VIR-7831 IDMC recommend Ph3 COMET-ICE antibody trial evaluating VIR-7831 (GSK4182136) for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment due to evidence of profound efficacy. 85% reduction for hospitalization and death. p=0.002. Previous another trial no efficacy. Treatment time matters.
KD025, belumosudil, PDUFA extended 3 months.
FDA approved Fotivda (tivozanib, VEGFR inhibitor) for 3rd line relapsed or refractory advanced renal cell carcinoma (RCC)
FDA identified deficiencies that preclude discussion of labeling and post-marketing requirements for its sNDA of Pimavanserin for allucinations and delusions associated with dementia-related psychosis. down 45% to $27.04.
investigation indicates AML not treatment related.
Ph2 luvadaxistat (NBI-1065844/TAK-831, oral inhibitor of d-amino acid oxidase (DAAO, developed by Takeda)) fail in negative symptoms of schizophrenia
2019 IPO integrin biology for oral integrin inhibitors. several IV integrin inhibtors already approved for IBD but no oral.
unexpected announcement of AdCom, PDUFA likely to be delayed, already postponed 3 months.
FDA CRL ask for CMC issue and human factor trial. Neutrolin a non-antibiotic anti-infective
CRL for oral paclitaxel plus encequidar (oral enabler) for metastatic breast cancer. need new trial.
was opioid player. now ADHD drug approved.
buyout by $AMGN for $38/share. was #belowcash $4 then. Zai Lab deal; was superstar before that.
VIR-7831 show little benefit, enrollment stop. -35%
2.47 gap closed. !!!
add 766 shares $1.96 $1.5k, pull back to 50MA 33% down
4Q20, FY20 CC: revenue 1M as guided. Loss 17.6M. COVID impact uncertainty.
'069 patent appeal timeline if no settlement-
- Decision usually w/in 90 days … likely October or November
Vascepa results controversial, new trial negative results, success trial control arm is mineral oil, potentially increase control arm rates. Advocates argue Japanese open label trial.
Otividex Ph3 for Ménière's disease failed again (previous failed in 2018)
FDA says Ph3 NurOwn data in Amyotrophic lateral sclerosis ALS does not provide the threshold of substantial evidence to support a BLA
acquired $PAND Pandion Therapeutics bispecific antibody for immune related diseases. 3X 2020.07 IPO
settle with $ABBV and Medytox for stealing trade secret of Botox. grant license in exchange of milestones and royalties to $ABBV and equity to Medytox.
$GSK invest $120M equity and pay $225 upfront to expand collaboration. COVID Ph3 due 1Q21
COR388 trial open label extension part on FDA clinical hold. Atuzaginstat COR388 is a novel virulence factor inhibitor targeting gingipains from P. gingivalis that have been found in the brain of Alzheimer’s patients.
Chromadex see Los Angeles article. Stock up on 40% faster recovery for COVID patients. 谭君子感兴趣. chat 20min regret.
initiate Ph2 combo trial with $ASMB
4Q FY20 CC, FY20 revenue $46.6M, up 32% from 2019 $35.2M, Heplisav 4Q 11.5M 26% Market share; 1Q2021 CpG 1018 revenue $40 ~ $60M
Schrödinger, Inc. a computational chemistry company founded in 1990, 2019 revenue $85M, IPO in 2020 with COVID ARKG and Bio IPO craze. now MCap $8B. pyMOL developer
Insilico Medicine (Hong Kong) 人工智能发现 IPF新靶点和候选药物
Clover raised $230 mil to work on variants and expand pipeline beyond COVID vaccine.
$MRNA filed appeal today by the 3rd extended deadline. No deal, but something is there. Why appealing if no infringement?
SCD trial suspended after AML SUSAE case. Leukemia risk obvious. LNP for Gene therapy! $AVRO down, similar tech
Dociparstat sodium is a potential first-in-class glycosaminoglycan compound derived from porcine heparin that has low anticoagulant activity In vitro and in vivo animal model data support DSTAT’s potential to reduce the inflammation and cellular infiltration associated with acute lung injury and address coagulation disorders associated with COVID-19 pathology.
2020.05 COVID Ad5 vaccine
2018 IPO. non-absorbed polymer removes HCl from GI and blood. "Durable, safe and effective long-term kidney drug data from Tricida fuel blockbuster potential" endpts article. CRL due to "the novelty of veverimer’s surrogate endpoint, the lack of precedent for cardio-renal drugs being granted accelerated approval, and the FDA’s diminished communication with sponsors in recent months in light of the lack of in-person meetings due to Covid-19. " was $2B now $340M.
Added 339 shares at $4.449 ($1.5K). anticipating Moderna and Genevant deal next Wed, in 3 trading days. Decided not to wait for $4 50MA level (original order). Better than $5. Not a big deal. Low next days: $4.25
Heplisav-B approved in Europe formally.
Only 2 Biotech Belowcash:
2 <= 1; 44 <= 2 (627 Biotech); price 80 <= 3
Healthcare -95% None -80% 4:
Healthcare 58; Y+500% 26: 11 related to COVID
$NVAX: COVID vaccine
$OCGN: COVID vaccine
$ACRS: Aclasris #Belowcash #Comeback Oral MK2 Inhibitor as TNF mab alternative
$ALT: COVID intranasal vaccine
$BNGO: Bionano Genomics, Saphys optical system "Resolve large-scale structural variations missed by next-generation sequencing (NGS) systems" 2018 IPO, down to penny, "Next-gen cytogenetics", raised twice 101M+230M in two weeks. Crazy market!
$CLDX: KIT inhibitor success
$RVP: retractable syringe
$CVLB: OTCBB stock uplisted, new symbol $LFMD, telemedicine
$BIVI: BIOVIE, BIV201, terlipressin approved in about 40 countries for liver cirrhosis but not in US. OTCBB uplist in 2020.09
$HGEN: COVID anti-GM-CSF for cytokine storm such as Cancer I/O and COVID, Lenzilumab (similar to $KNSA) OTCBB uplist in 2020.09
$IPA: canadian ImmunoPrecise Antibodies ab discovery uplist 2020.12
Another Investigator-Initiated Study of DSUVIA® in Patients Undergoing Plastic Surgery Procedures (Orange County)
ARK $ARKG now owns 25 companies' >10% owership. Janus 20 fund in tech bubble
RA capital digram $NVAX Matrix-M side effects are stronger than AS03, especially for headache, fatigue and muscle pain. Good news for $DVAX, which is way safer than AS03 already in Clover and Medicago trial as well as Heplisav trial.
2021.2.16 Correction: Shingrix uses AS01B, contains MPLA, a TLR4 agonist. TLR4 is a bad pathway for specificity, hence poor side effects. Matrix-M side effects ~> AS01B > AS03 >> CpG. $NVAX $DVAX
eryaspase /GRASPA® (asparaginase packed in donor RBC) Cancer metabolism Tumor starvation. Ph3 second-line pancreatic cancer will continue. Investors was hoping for early stop with sufficient efficacy.
Eagle, mediore since 2015 patent win rise
Ph2 KVD900 (kallikrein inhibitor) as an oral on-demand treatment for hereditary angioedema (HAE 遗传性血管性水肿) attacks. reduced use of rescue treatment (p=0.001) from 30% to 15%. Maintained at 24 hours (p=0.0005)
Phase 3 with $GILD of ziritaxestat for idiopathic pulmonary fibrosis discontinued due to insufficient efficacy -70% from peak
pivotal trial for AT-GAA for Pompe Disease primary endpoint of the change in 6-minute walk distance as compared with baseline measurements not met. 21m vs 7m but p=0.072. Still intends to BLA due Q2.
eganelisib IPI-549 PI3K-gamma inhibitor + PD-1 in platinum-refractory, I/O naïve patients with advanced urothelial cancer: 30% ORR vs 25% PD-1 only. In PD-1 negative, 26% vs 14%, up 13%
raise $36M at $7/share with half amount of warrant exercise-able at $7 in five years. price tank and hover around $7.3. Glad did not add.
Philadelphia based Ocugen to bring India Bharat Biotech's vaccine to the US, stock price rise from $0.29 on December 21 to $18.77 as of 2.8.2021 in ~6 weeks. Crazy! @Dirk, use alum, likely will be rejected by FDA for inadequate data/trial, don't expected to be distributed in the US, pump and dump.
Dong Yu joins from GSK Vaccines as Senior Vice President of Vaccine Research 葛兰素史克（GSK）抗原鉴定和分子生物学美国临床前研发总监余东
FcRn is the primary protein responsible for preventing the degradation of IgG antibodies and albumin, the most abundant protein found in the blood. The role of FcRn is to bind to the IgG antibodies in the endosome, and transport them to the cell surface, where they are released back into circulation. Other proteins are degraded if non-receptor bound.
IMVT-1401 is designed to selectively bind to and inhibit FcRn, thus blocking the recycling of IgG antibodies.
Trial voluntary hold due to a physiological signal consisting of elevated total cholesterol and LDL levels in IMVT-1401-treated patients in ASCEND GO-2, a Phase 2b trial in Thyroid Eye Disease (TED).
Ph2 fail CTP-692 for schizophrenia. CTP-692: a deuterated form of D-serine, an endogenous amino acid that is a co-agonist of the NMDA receptor.
failed in 2018, to initiate confirmatory trial of Birtamimab for newly diagnosed, treatment naïve patients with AL amyloidosis. Target p value <= 0.1 unprecedented.
declined in 2020, had partial clinical hold lifted on the AT-007 ACTION-Galactosemia Kids pediatric trial Now lifted.
Arcutis Biotherapeutics 2020.01 IPO Topical roflumilast cream (ARQ-151) is a small molecule inhibitor of phosphodiesterase type 4 (PDE4), an intracellular enzyme that increases the production of proinflammatory mediators and decreases production of anti-inflammatory mediators, and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and chronic obstructive pulmonary disease (COPD).
FDA approved ublituximab (anti-CD20) for relapsed or refractory marginal zone lymphoma (MZL) and for patients with relapsed or refractory follicular lymphoma (FL)
FDA approved Posimir (bupivacaine solution) to produce post-surgical analgesia following arthroscopic subacromial decompression. AdCom 6-6. Twice the mcap of $ACRX
oral COVID-19 tablet vaccine candidate. Neutralizing antibodies were not detected in serum and Immunoglobulin G (IgG) responses, a type of antibody, were also not detected in most subjects. Spike and crash
buyout $VIE for $53 in cash $3B 2.5x since IPO only 15 months
buyout by Jazz for $220 per share 7.2B total ($200 cash + $20 Jazz shares)
@Dirk find that CpG1018 patent expired in 2018. would think that agreements would prohibit 'partners' from going off on their own.
Serum Institute of India collaboration Tdap-1018 dosed first patient Ph1 trial. DVAX has worldwide rights to commercialize exclude India and UNICEF contracts. Shared development cost by the same territory division. Data due 4Q21. No alum in protocol. Trial in Australia in Healthy Volunteers between 10 - 22 years of age (younger age than Heplisav) 24+250 subjects. Safety is primary outcome endpoint.
bioRxiv paper showing "Neutralization of SARS-CoV-2 VOC 501Y.V2 by human antisera elicited by both inactivated BBIBP-CorV and recombinant dimeric RBD ZF2001 vaccines"
1)If true, very good news for the world, no need to develop new vaccine, just use adjuvant to boost existing vaccine.
3PR in one day: UK announced exercise option for 40Mil additional doses of Valneva vaccine
Added 200@$7.665 total $1.5k spike above $10 in a few hours. Right after 药明康德 talk about T cell immunity.
T cell immunity important in protection against severe COVID of variant, says JNJ executives.
23mil shares short, potential fuel for substantial rise?
@Steam_Sports: $MRNA recently filed for another (3rd one) extension of time to file its principal brief in its appeal v. $ABUS. Moderna's brief is now due 02/24. I imagine there are settlement discussions ongoing as the date keeps getting pushed out.
Bellicum FDA lifted clinical hold on Ph1/2 trial of BPX-601 and rimiducid in patients with previously treated metastatic pancreatic or prostate cancer. An autologous GoCAR-T® product candidate containing our proprietary iMC co-activation technology, designed to treat solid tumors expressing prostate stem cell antigen (PSCA). PSCA is a cancer antigen expressed in several solid tumor indications, including pancreatic cancer.
aducanumab PDUFA extended 3 months
Medigen 1 dose did not happen; NVAX tox?
XX2 Fc antibody VIR-3434 "T cell vaccine" achieved 1.3Log10 HBsAg reduction by day 8 in 6/8 blinded patients (2 placebo). With only 6mg dose (3000mg MTD). #HBV $ABUS
announced 2021 goals, cash increased 5mil ($40M ATM?) 10-15M shares sold. Announced two more Ph2a trials with AB-729 in 2H21; AB-836 Ph1 in 1H21.
MedigenVAC Ph2 dosed 1st patient
anti-LAG3 developed for autoimmune disease GSK2831781 (licensed from french company Immutep). Ph2 trial for active ulcerative colitis discontinued.
Merk KGaA / GSK bintrafusp alfa (bispecific anti-TNGb and anti-PD1) fail Ph3 in NSCLC compared to Keytruda along. Deal was €300M upfront + upto €3.4B
Ph2/3 troriluzole for mild-to-moderate Alzheimer's disease (AD) fail
$RPRX (a Royalty company) acquired its royalty interest in seltorexant for an upfront payment of $60m and up to $95m milestones.
TI-450, an Oral MK2 Inhibitor as TNF mab alternative, Ph2 success, was #BelowCash from $0.7 to $18. Company accept commercial failure, refocus, management change, fall below cash, rebound eventually.
Voclosporin, potentially best-in-class CNI (calcineurin inhibitor), approved FDA, 1st drug for Lupus Nephritis. Lower than Ph3 success announced.
Jan 2021 corp ppt mentioned ARX-02 ARX-03 for the first time for a long time.
up 600%+ in a month with '2nd gen' COVID vaccine, funding from Gates Fundation, targeting multiple viral component, T cell immunity. AAV prime + LNP samRNA boost. Using Genevant tech, licensed expanded anonymously in Oct 2020. Not sure if will be used. But for preparedness. Announced new license deal 1.20.2021 up to 192m milestones plus royalties. So October deal is something else.
pop to $2.94 then raise AH, just as I feared. Suddenly break out upwards in huge volume after H.C. Wainwright Bioconnect 2021 Conference
PLK1 inhibitor Ph1b update disappointing, a little down from previous update in 2020.09, peaked at 25.5 on 12.1.2020 now lost almost half. Resistance at 200wk MA. Continue to decline to $6? Was a wechat group discussion. I did not jump in.
US government buying additional upto 1.25m doses of casirivimab and imdevimab antibody cocktail delivered by June 30, 2021, in addition to the current supply of doses to treat 300,000 people under a previous agreement
divest Inbrija manufacturing to Catalent for $80M, also save $40M cost per year. up 63%. Performance has been horrible.
anti-beta-amyloid Donanemab Ph2 success, met the primary endpoint, slowing the decline of patients on the Integrated Alzheimer's Disease Rating Scale (iADRS) by 32% relative to placebo. can it translate to Ph3? $BIIB also up on the news
Read Medigen paper more carefully. The titer with one dose is really strong, comparable to some two-dose vaccines.
The plasmid expressing SARS-CoV-2 (strain Wuhan-Hu-1 GenBank: MN908947) S protein ectodomain was obtained from Dr. Barney S. Graham (Vaccine Research Center, National Institute of Allergy and Infectious Diseases, USA) and contains a mammalian-codon-optimized gene encoding SARS-CoV-2 S residues 1–1208 with a C-terminal T4 fibritin trimerization domain, an HRV3C cleavage site, an 8 × His-tag and a Twin-Strep-tag 9. The S-2P form was created by mutation of the S1/S2 furin-recognition site 682-RRAR-685 to GSAS to produce a single-chain S0 protein, and the 986-kV-987 was mutated to PP9.
$ABUS. Genevant licensing deal with $SRPT for development of muscle targeted LNPs for gene editing targets in early stage development. Sarepta will have rights to an exclusive license to Genevant’s LNP technology for up to four neuromuscular indications, including Duchenne muscular dystrophy.
struggling BlueBird Bio split into two companies
CSO leaving, company hops on to iPSC NK for cancer train
discontinued lead candidate MLE-301 (NK3R inhibitor) after reviewing PKPD data Ph1a SAD healthy volunteers. "highly competitive NK3R antagonist market". to liquidate or merger.
Ph1 update on XMT-1536 ADC targeting NaPi2b ORR decreased from previous 35% (7/20) to 28% (13/47) -29%. was #BelowCash #10X
telaglenastat (Glutaminase Inhibitor, CB-839) in combo with cabozantinib (kinase inhibitor) fail advanced or metastatic renal cell carcinoma (RCC). No PFS difference. Tumor metabolism. Lay off 35% staff. -45%
Imara 2020.03 IPO, IMR-687 PDE9 inhibitor to boost cGMP failed sickle cell disease Ph2a. Poor data quality. Mono arm had 25% less VOCs/SCPCs yet HbF -1.1%. Combo IMR-687+Hydroxurea no change in VOCs/SCPCs. +3% Hbf goal unlikely to meet in Ph2b.
IV board really quiet no post since 2020.12.16
reproxalap (RASP inhibitor to reduce aldehyde) for dry eye disease release data top-line symptom, redness, and Schirmer’s test results from the run-in cohort of the Phase 3 TRANQUILITY clinical trial. Main cohort to enroll next month data due 2H21
Phase 3 HELIOS-A trial of vutrisiran for transthyretin-mediated (ATTR) amyloidosis, met its primary and both secondary endpoints, compared to historical placebo data from the APOLLO Phase 3 study of patisiran. Self innovation.
SRP-9001 Study 102 Ph2 trial part 1 data release met primary biological endpoint of improvement in micro-dystrophin protein expression, miss primary functional endpoint, of a significant increase in NSAA total score (a muscle function test score). down 51% raising serious questions about all their drugs
previous TapImmune (peptide vaccine for cancer) merged with Marker in 2018 and adopted its name and Multi-Antigen Targeted Cell Therapy tech.
final immunogenicity data 89.3% after 4-dose 16-week regime in Patients Undergoing Hemodialysis
relugolix deal with $PFE $650M upfront, up to $4.2B
2019 IPO. eprenetapopt prodrug for methylene quinuclidinone MQ. MQ binds to TP53, stabilize and reactivate mutant p53.
Arbaclofen, previous met only 1 of 2 endpts in 2nd Ph3 got CRL, FDA asking new trial.
CEPI partners with Biological E Limited to advance development and manufacture of COVID-19 vaccine candidate $5M upfront
poly A tail has UGC sequences, wechat
A tale of not-so-pure tails
Providence Therapeutics PTX-COVID-B mRNA/LNP vaccine enters clinical trial using Genevant tech
2020.03.11 $CPC MACD 0.183 20MA 1.10 $BPHEAL 5
2020.03.12 $CPC MACD 0.208 20MA 1.13 $BPHEAL 0 (FIN, Uti, Mat, Indy also 0), NetGap -2747(highest again) $VIX > 77
2020.03.13 10% bounce $CPC MACD 0.214 record 20MA 1.16
2020.03.16 12% drop, 0.221 record, 1.18
2020.03.17 MACD bullish turn, 20MA 1.19
2020.03.18 20MA 1.22
2020.03.19 20MA 1.23
2020.03.20 $VIX decline
03.24 $VIX continue to decline, $CPC MACD crossover, 20MA decline, volume light, wait for second leg and follow through. Energy sector is weakest in this crisis. Tech, Consumer Disc, Health relatively OK.
In 2008-2009 crisis, $CPC not a good indicator
4.2,6,9 three follow through days. Watch for bottoming stock, add $ABUS
4.17 healthcare sector recover the fastest, $BPHEAL strong 93% all the way, XLV almost new high
4.27 Break above 50MA 原油持续低迷 期货到期负油价可能持续多月 中行巨亏300亿
5.18 Up big with 2247 (2279:32) net gap on $MRNA vaccine news, largest NetGap on record.
5.26 1814 .6.05 1721 up gaps, gap up 2.56% on huge volume amid much better than expected job report, $COMPQ new high QQQ new high 06.03, AAPL new high
6.11 Gap 29:2572 $VIX spike 50% to 41, but volume soso, nice consolidation to scare weak hands on "2nd wave fear"
another collaboration with Serum Institute of India. They already have manufacture deal with $ANZ and $NVAX. They still feel the need to develop their own and yet another one at this stage.
maybe bad time for Valneva to start trial now. @fairvalueforyou hard to recruit? hard to say
2019 IPO. setrusumab (anti-sclerostin) deal with Ultragenyx $RARE for osteogenesis imperfecta (OI) worldwide rights exclude Europe. $50M upfront. Up 63%
2019.06 IPO AAV9-based gene therapy targeting CNS such GBA1 or GRN. Acquired by $LLY for $22.5. IPO $17
Azeliragon failed for dimentia in mild-AD in patients with type 2 diabetes. TTP488, orally bioavailable small molecule that inhibits the receptor for advanced glycation endproducts (RAGE). failed in 2018. This compound was discovered by TransTech Pharma as TTP488 and licensed to Pfizer as PF-04494700
#E3ligase ARV-110 (degrades AR) show 50%+ PSA levels drop in 2/5 patients with certain Androgen Receptor AR mutations, heavily pretreated. How is it related to AR protein degradation? AR-471 (degrades ER) show some evidence in heavily pretreated locally advanced or metastatic ER positive / HER2 negative (ER+/HER2-) breast cancer. To initiate combo trial with Ibrance® (palbociclib). Up 130% and raise $400M.
to resubmit NDA after CRL in October. Up 75%
roxadustat for anemia of chronic kidney disease (CKD) PDUFA extended by 3 months due to the submission of additional analyses of existing data from the company.
FDA approved Margenza + chemo for 3rd line metastatic HER2-positive breast cancer. No prive move
FDA approved Orgovyx (relugolix, GnRH receptor antagonist) for advanced prostate cancer. no price movement
FDA approved Xpovio (selinexor) + bortezomib and dexamethasone for 2nd line multiple myeloma. Move from previous 5th line to 2nd line. no price move
valneva trial started, readout early Q2
nanoFlu phase 3 only 2652 patients, Matrix-M safety database small
10X? new high, up on strong sales in 3Q20. Approved 2 years ago. Did not rise until now. Did not understand the eye disease market. Was impressed by its tech.
$BNTX Acuitas LNP formulation. Not in '069 patent range
Cirmtuzumab + ibrutinib 87% reported for 15 patients with relapsed/refractory mantle cell lymphoma
GDA-201 NK cell therapy Ph1 success for non-Hodgkin lymphoma (NHL, 74% ORR in 19, 68% CR) and multiple myeloma (MM). Only 2X year return
2018.01 reverse merger of Inotek ($ITEK, glaucoma and eye diseases). AAV and LVV gene therapy company.
Pluristem Therapeutics human placental adherent stromal cells. Ph3 discontinued for futility for PLX-PAD cells for critical limb ischemia (CLI). 间充质细胞 间充质干细胞 免疫调节
CURIS 2000 IPO. long term mediocre. 2018 1:5 reverse split. Ph1 success CA-4948 in acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS). Blast reduction in all patients and 2 CR.
ublituximab (anti-CD20), met Ph3 endpoints, compared to teriflunomide (MOA unknown) in relapsing multiple sclerosis (RMS) #10X
FUROSCIX 2nd CRL. 1. inspections not possible 2. testing, labeling, and features 3. third-party facility for alcohol swabs
FDA accepted NDA for brincidofovir (BCV) as a medical countermeasure for smallpox
remarkable website gaffe in regard to its New Drug Application for Tlando. Published on their website was a post that noted Tlando had been approved by the FDA as an oral testosterone replacement therapy (TRT). This initially saw shares climb over 20% in Tuesday’s after hours’ session, only for the company to later issue a press release that an independent contractor had mistakenly posted the information to the website without authorization and as a result the company deleted the posting. Lipocine later announced that the FDA had issued "tentative" approval but is not eligible for final approval until the expiration of the exclusivity period previously granted to Clarus Therapeutics, Inc. with respect to Jatenzo, which expires on March 27, 2022. Shares closed Wednesday down 21% to $1.32.
acquired by $AZN for $175/share in cash and stocks, $60+$2.1243 $AZN shares, $39B
60mg Q8W safer and as effective knock down
raise 10M @$1.20/share
EU EMA CHMP positive opinion
$BNTX16-19% fever 5-6% severe fatigue 4-5% sev. headache, compared to $DVAX Heplisav 1.7%, 1.6% & 1.5%. Plenty room left for improvement.
$500M investment by Sino Pharm 中生生物 for 15% equity, other debt holder converted
Twirla launched with contradiction to BMI>=30. Maybe why only estimating 5-8% TRx. US women are overweight
$LQDA CMC CRL. LIQ861 inhaled dry powder formulation of treprostinil for Pulmonary arterial hypertension. LIQ861 particles are a precise, uniform size and trefoil pollen-like shape designed to have ideal aerodynamic properties for deep-lung delivery. 2018 IPO, precise particle design, lost 90% since post-IPO peak.
gaboxadol GABAA receptor agonist for rare Angelman syndrome failed Ph3
2018 IPO, Cell-free biologics manufacturing including cytokines, ADC, bispecifics. Oncology focus, partnership and inhouse
FDA feedback on Roluperidone "the lack of two adequate and well-controlled trials to support efficacy claims"
FDA approved oral, once-daily Orladeyo (berotralstat, BCX7353) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
Company founded in 1986, long history of mediocre performance
up a lot for no reason MRNA hype?
Baker Brothers selling 1.5% share outstanding 1.5M shares at $225, Beigene bare cost :)
Clover Ph1 results, immunogenicity not as good as GSK AS03. superior safety, same as in Medicago trial. Delayed Ph3 start waiting for Heplisav-B Ph4 results or Ph1 expansion?
$DVAX both charts look promising, decreasing volume decline to form handle
“People are afraid of missing out and would rather invest and be wrong than miss out. I don't think it's predictive of whether it will be a success, it certainly enables success,” says margaret Liu. $ABUS
How could journalists and prominent scientists talk about LNP without giving credit to Arbutus $ABUS ? ego, money, or ignorance? What is at stake? @JohnMaraganore
$MRK sold $MRNA stake, cashing out
1:25 reverse split
Medigen results by mid year 2021; Mount Sinai universal flu vaccine entering Ph1 trial soon
BrainStorm Cell Therapeutics Inc. down 66% Ph3 NurOwn for Amyotrophic lateral sclerosis (ALS) failure. NurOwn repeat-administration of autologous MSC-NTF cells (Autologous Cultured Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors ) 分化自体分泌神经营养因子间充质干细胞 完全是跑概念
$BNTX Genevant BNT171 first candidate from BioNTech/Genevant collaboration (agreement contract). It is listed here in $BNTX pipeline. Also From BioNTech Form S1 IPO paper. Expected to enter Ph1 trial
Our Rare Disease Protein Replacement mRNA Product Candidates
Ph3 AAV5 gene therapy etranacogene dezaparvovec for severe and moderately severe hemophilia B, met the primary endpoint with Factor IX (FIX) activity increasing after dosing from ≤2% to a mean of 37.2 percent at 26 weeks.
CCR4 antagonist FLX475 Ph2 1/22 PR down -46%
2nd CMC CRL for Zimhi high-dose naloxone injection for opioid overdose
Lisocabtagene maraleucel (liso-cel) is an autologous, CD19-directed, chimeric antigen receptor (CAR) T-cell developed by Juno-Celgene-BMY, PDUFA delayed due to FDA COVID-19 travel restrictions
lonafarnib (farnesyltransferase inhibitor) FDA approved for Hutchinson-Gilford progeria syndrome 早年衰老症候群 LMNA(Lamin A) mutation not its direct target. Poor stock performance
new publication commentary on the benefit of Dsuvia
ALNY leader 14B HBV partnered to VIR as VIR2218
MPOWERED results announced 91% of patients on MYCAPSSA maintained IGF-1 defined as the time-weighted average of IGF-1 <1.3 x upper limit of normal (ULN) during the 9-month randomized, controlled treatment (RCT) phase. pop then ended lower.
new collaboration with BCM Ventures (Baylor) and Indian Biological E. Limited for RBD protein subunit COVID vaccine with CpG1018+Alum. paper immunogenicity, biochemistry, search results
Urovant buyout by Sumitovant Biopharma, a joint venture between Softbank, Sumitomo Dainippon and Roivant
2012 IPO Calliditas Therapeutics Ph3 success Nefecon for primary IgA nephropathy (IgAN) significant reduction in urine protein creatinine ratio.
Zai Lab partnered bemarituzumab (FPA144) anti-FGFR2b success in gastric cancer but p value not so good. +328% from $5 to $21
CMC CRL on SPN-812 for ADHD. Refuse to File on SPN-830, apomorphine infusion pump
Does BionTech use $ABUS tech, even though it collaborated with Acuitas?
Aptevo Therapeutics spinout from $EBS Emergent BioSciences early success with its APVO436 (bi-specific CD123xCD3 with less tox than $APVO developed and licensed MDG006) in Ph1 AML and MDS. 1 patient got complete response.
MT-3724 using its Engineered Toxin Bodies (ETBs) platform put on clinical hold following a treatment-related fatality in one subject in the Ph2 monotherapy trial. Grade 5 capillary leak syndrome (CLS), markedly higher than expected peak drug exposure (Cmax).
FDA briefing positive, clinical review positive but statistic reviewer disagree. Up 44% for such a big cap company.
AdCom doesn't like it. 0-10-1abstention
VBR, or ABI-H0731, trial failed to meet meaningful rate of sustained virologic response off-treatment. Almost everyone relapsed. To continue Ph3 for chronic suppressive therapy for 10-30% of HBV patients who only achieve partial viral suppression after a year or more on NrtI (nucleos(t)ide analogue reverse transcriptase inhibitor) therapy. A collaboration in China with Beigene.
Valneva supply price $2.15/dose, expect 130 - 230M revenue in 2021 and 400M+ through 2024 per UK agreement.
3Q20 sales 1.3M, going up but still marginal, touting recent momentum, not profitable until 4Q22 when new production line ready. Negative gross margin right now.
bb1111 LentiGlobin™ for Sickle Cell Disease Gene Therapy will need to prove “analytical comparability” as it transitions from clinical-grade to commercial-grade manufacturing. BLA submission timing to late 2022
Q2+July: 80.8mil shares, 51.9m ATM. Q3: 84.6mil shares 66.1m ATM ($3.73 share new ATM)
$AXON 1:8 reverse split in 2019.05 after previous $AXON failure. Now AXO-Lenti-PD trial delay indefinitely due to CMC.
Ph3 stop recruiting early due to obvious benefit, Motixafortide (BL-8040, targeting CXCR4) in Stem Cell Mobilization, micro cap $30M $XFOR same target, no response to news, $93M mcap
MRTX849 KRAS G12C adagrasib in NSCLC 45% ORR. To file NDA in 2H21, offer $926m.
2018 IPO, TGFb biology, By targeting the latent form rather then mature form, SRK-015 avoids blocking the activity of other closely-related members of the TGFβ superfamily that may lead to undesirable side effects.
Genevant licenses LNPs to Gritstone, a previous licensee.
reverser merger with Viridian anti-IGF-1R monoclonal antibody, VRDN-001, intended for the treatment of thyroid eye disease (TED), abandon miRNA
buyout Grail for early cancer detection $8B
Beam Therapeutics using LNP to deliver CRISPR PCSK9 to liver. Just found another pair of companies to add to my LNP list. It seems the whole world is using LNP and nobody cares about $ABUS self claimed patent coverage. Verve and $BEAM. Of course, they " ..have developed several proprietary LNP formulations and have shown effective base editing of a surrogate target in mice at low doses..."
Cleveland Biolabs founded in 2003, IPO in 2006, develop Entolimod (TLR5 agonist) for radioprotection. lost 99% value since IPO. 1:20 reverse split in 2015. Now reverse merger with CytoCom. Cytocom has AIMS™: Advanced Immunomodulating Multi-receptor System platform. Newly created multi-receptor Immunomodulating platform developing thousands of analogs from noroxymorphone & proenkephalin to treat numerous cancer, inflammatory, autoimmune and infectious diseases
Endo acquires BioSpecifics Technologies Corp $BSTC for $540M.
FDA #CRL for its Qtrypta (zolmitriptan intracutaneous microneedle system) for Migraine. FDA recommended a repeat bioequivalence study before resubmitting its NDA.
combined epitope (9 conserved peptide) universal flu vaccine Ph3 failure, no protection vs placebo. Exploring assets sale such as IP and manufacturing capacity $DVAX
Medicago receive Canada government supply agreement 76M dose, $173M funding
Atea Pharmaceuticals got $350 upfront cash for ex-US rights of AT-527, a oral viral RNA polymerase for COVID-19. Former Pharmasset co-founder Jean-Pierre Sommadossi
CTX110 is an allogeneic CRISPR/Cas9 gene-edited CAR-T cell therapy targeting CD19 in development for the treatment of CD19+ malignancies. One patient died at highest dose.
Microcap+ (>50m) Biotech Belowcash
20 <=1; 95<=2 (585 Biotech); price 152 <= 3
Healthcare 43; Y+500% 22:
market potential $1.1B US + $800 EU for Dsuvia and $700 total for Zalviso. 0.7~2.5B sales. 2.5-10B Mcap. 5B most likely.
$FBIO FDA CRL for IV tramadol, reformulated 25y old generic opioid pain med, intended to treat patients in acute pain who require an opioid, is not safe for the intended patient population. "Specifically, if a patient requires an analgesic between the first dose of IV tramadol and the onset of analgesia, a rescue analgesic would be needed. The likely choice would be another opioid, which would result in opioid “stacking” and increase the likelihood of opioid-related adverse effects." $ACRX
IFN-lambda show promising early results treating COVID-19 in high viral load patient: “…For those with baseline viral load > 6 log copies/mL, the proportion negative at Day 7 in the Lambda group was 15 of 19 (79%) compared to 6 of 16 (38%) in the placebo group (p=0.013). This difference translated into a median time to clearance of 7 days with Lambda compared to 10 days in the placebo group (p=0.038)….”
DP2 antagonist, GB-001 failed both asthma and chronic rhinosinusitis. $NVS same MOA failed asthma in YE2019
down 14% due to $JNJ COVID-19 vaccine trial pause, $EBS has manufacturing agreement
Vx-814 discontinued due to elevated liver enzyme. Vx-814 is a small molecule that corrects the misfolding of AAT, theoretically allowing it to exit the liver and function properly to treat Alpha-1 Antitrypsin Deficiency. To focus on VX-864
Vertex story on protein folding including CF Cystic Fibrosis
resTORBio reverse merger with Adicet Bio T cell company
Replimune oncolytic immunotherapies Immulytic™ platform. HSV1 oncolytic virus with GM-CSF & a potent fusogenic protein (GALV-GP R-). RP2 and RP3 are derivatives of RP1 that express additional proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses optimized immune co-stimulatory pathway ligands.
Bausch Health licensed MicroPine for US and Canada, 10mil upfront and 35mil milestones and mid-single digit to mid-teen percentages of gross profit on sales
GSK to take over
two CHMP positive opinion in 1 day: PCSK9 RNAi ($NVS partnered) and OXLUMO™ (lumasiran) for rare kidney disease Primary Hyperoxaluria Type 1
KOL day ppt
olinciguat for SCD failed Ph2, discontinue
$JNJ AAV COVID vaccine on pause; just like $AZN AAV vaccine
InhibRX, 杨桢霄tip,single domain antibody (nanobody), similar to ABLX Ablynx, added multivalency engineering. three Ph1 candidates: 4X DR5, 6X OX40, 4X PD-L1+4-1BB, and one enzyme AAT-Fc (Alpha-1 Anti-trypsin) fusion. Good chance of buyout once concept proved. Clinical data coming, binary event on these first in class targets.
La Jolla based company. UCSD, Sanford-Burnham
ABLX Ablynx first approved sdab: https://en.wikipedia.org/wiki/Caplacizumab
2018 IPO, AG10 small molecule to stabilize TTR, acquired by $BBIO for the rest 36.3% it does not already own.
aquired by $BMY for $225 per share, $13.1B, another 80% $100 rise since May peak.
Ph2b failure of lenabasum (agonist to the cannabinoid receptor type 2, CB2) for cystic fibrosis
$AMGN collaboration Ph3 omecamtiv mecarbil (cardiac-specific myosin activator) in patients with heart failure with reduced ejection fraction (HFrEF). met the primary composite efficacy endpoint reducing cardiovascular (CV) death or heart failure events compared to placebo. However, it did not meet the secondary endpoint of reduction in cardiovascular (CV) death, which saw shares tumble with Cytokinetics shares closing Thursday down 42%, AMGN -7%
discontinued anti-miR155 cobomarsen for Cutaneous T-Cell Lymphoma (CTCL) after Ph2 failure
Ph2 success of anti-GMCSFR mavrilimumab in giant cell arteritis (GCA)
贼喊不捉贼 Thief touting not to catch thieves. $MRNA not to enforce patents.
PearChris on Yahoo:
acquired by Covis Group for $13.75 per share in cash. 2015 peak $70+
FDA lifted clinical hold on DMD AAV gene therapy. was expected to resume in 1Q2021
SEL-212 (ImmTOR+pegatricase) failed comparison trial to Krystexxa (Pegloticase) for chronic refractory gout. Complicated Immuno tolerance story
Synthetic Biologics, Inc. SYN-010 is a modified-release formulation of lovastatin lactone that is intended to reduce methane production by certain microorganisms (M. smithii) in the gut while minimizing disruption to the microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C).
Penny stock 1:35 reverse split in 2018, a few GI drugs, very hard area.
was below cash, FDA demand new trial in 2018. Now expecting rolling submission for pacritinib for myelofibrosis with severe thrombocytopenia. Well ahead of previous guidance. Potential 10X candidate
submitted NDA for sulopenem etzadroxil/probenecid for uncomplicated urinary tract infections (uUTI) with a quinolone-resistant pathogen. Previously failed non-inferiority in complicated urinary tract infections (cUTI)
CRL for remestemcel-L for pediatric steroid-refractory acute graft versus host disease (SR-aGVHD) despite 9-1 AdCom. FDA demand additional trial. Alread 8B MCap
$BHC FDA approved Alaway Preservative Free ophthalmic solution, 0.035%, antihistamine eye drops (EM-100) to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander. Previous CRL.
expanding liquid biopsy screening test to various cancers. Across six cancers the test achieved overall sensitivity (ability of a test to correctly identify positive cases) of 86% and specificity (ability to correctly identify negative cases) of 95% in 437 samples.
AC Immune and Roche (RHHBY) Ph2 failure for Alzheimer’s disease with the anti-Tau antibody semorinemab. Miss reducing decline on Clinical Dementia Rating-Sum of Boxes (CDR-SB).
avapritinib (already approved) Kit PDGFRa inhibitor, Ph1 Ph2 success in advanced systemic mastocytosis (SM), analyst thought this indication more important. Up 13%
Ph2 failure of its lead candidate, pepinemab for early manifest and prodromal Huntington’s disease (HD).
pepinemab is a first in class, anti-SEMA4D therapy for neuroinflammatory/neurodegenerative disease. Is expressed by many tumor cells as well as by other cells in the tumor microenvironment.
2020.05.16: $BMY Idecabtagene vicleucel (ide-cel; bb2121) anti-BCMA (B-cell maturation antigen) CAR-T cell therapy for multiple myeloma by Celgene and bluebird bio Refusal to File Letter issued for BLA filing due to CMC defect.
New board member Peter Paradiso, from CEPI R&D and manufacture committee. retired in 2012 from Vice President, New Business and Scientific Affairs for Pfizer Vaccines, a Division of Pfizer, Inc.
CFO to retire
gap closed on a big down day with light volume
2020Oct16Call7: reached contract low of $0.20, Time value decline significant, hard to hold and wait to this late with "data expected September"
2020.09.22 continue to decline, but no option volume
add 4@$4.89 lending rebate, lower than gap
Awarded contract from DOD for clinical practice guideline study, up to $3.6M, in addition to previous SKO deals
Analyst day -10% sell on news:
continue to break up after 200MA and on a big down day.
only release 3 monthly dose data. Cannot compare to single dose data from $ABUS yet.
reverse merger with private AT-1501 (anti-CD40L) company Analixis, Analixis CEO, CSO, President to lead Novus.
$GILD buyout $88 10X since COVID low total $21B
FDA CRL cannot approve the NDA in its current form and requires more information to support a positive risk-benefit profile for terlipressin 三甘氨酰赖氨酸加压素 for patients with hepatorenal syndrome type 1 HRS-1. currently not available in the United States, or Canada, but it is available in New Zealand, Australia, much of Europe, India, Pakistan & UAE.
Ph3 success ganaxolone GABAA neurology drug in CDKL5 deficiency disorder (CDD), a rare, genetic epilepsy with refractory seizures. significant 32% reduction in 28-day major motor seizure frequency, compared to a 4% reduction for those receiving the placebo (p=0.002).
Mediocre stock perfomance
onvansertib, PLK1 inhibitor targeting KRAS pathway Phase 1/2 in KRAS-mutated metastatic colorectal cancer (mCRC) 5/11 (45%) PR and 5 SD. Up 46%.
was $TROV, had good data in 2019.08 $2, but continue to decline to low of $0.70 COVID. Start to rise after AACR. now $9. Changed name to Cardiff in May, new CEO ( was CSO in 2013, pivoted the transition), focus on PLK1 inhibitor and oncology.
Bravo to $MRNA Moderna for disclosing details in https://modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf including its key lipid, SM-102, which is "lipid 8" in its 2018 Cell pub'n http://cell.com/molecular-therapy-family/molecular-therapy/pdfExtended/S1525-0016(18)30118-7 (using 50:10:38.5:1.5 LNP), and sold by Organix ("lipid 8") at http://expocadweb.com/20tides/Data/EC/Event/Exhibitors/95/productBrochure5.pdf as a "cationic lipid"
Also disclosed at Ph1 trial info:
break 200MA the first time since approval. rumoring multiple parties for Europe deal.
$MRNA $VTRX deal on MRNA+LNP genome editing for CF. $75M upfront. Sue?
release 90mg AB-729 single dose 12week data -1.23 (0.18) log decline, trend continues, 1/6 grade 1 ALT/AST flare, testing 60mg Q4W Q8W, 90mg Q8W Q12W. data to release later this year
HCW conference: 1. 30% Q2 2. back to 70% will the awareness increase market? 3. CKD data, 10% 4. Cell mediated may be important, adjuvant will be important, high risk population 5. partnership multiple candidates, up to 1B dose capacity, add partners 6. International market deal coming?
Some vaccine will be in -80C; Valneva or DVAX vaccince will be standard 2-8C
DSUVIA® Added to the U.S. Department of Defense's Joint Deployment Formulary, available to all branches of the military
Valneva and Dynavax Announce Commercial Supply Agreement for Inactivated, Adjuvanted COVID-19 Vaccine VLA2001.
UK deal. 60M dose in 2021 for €470M ($557M), $9.3/dose, $1 for $DVAX?. Option for the rest 130M doses.
7.31 PPT merge ongoing no less than 60% Catheter Precision / 40% Hancock Jaffe; milestones
was 40X Y+300%. $25M direct offering to Pfizer followed with public offering $130M. Closed strong up with offering. CD47 player using SIRPalpha.
Phase 2a ziritaxestat (GLPG1690, autotaxin inhibitor) for diffuse cutaneous systemic sclerosis (dcSSc) success change from baseline in the modified Rodnan Skin Score (mRSS) at Week 24, of -8.3 vs -5.7 for placebo.
2019 IPO Phase 3 #failure STS101 powder for migraine miss endpoints freedom from pain and freedom from most bothersome symptom.
STS101 dihydroergotamine mesylate (DHE) nasal powder, a new formulation other than IV or liquid nasal spray.
-80% to $1.88 on Ph3 failure lenabasum (agonist to the cannabinoid receptor type 2, CB2) for diffuse cutaneous systemic sclerosis (SSc) 全身性硬化症
reverse split 1:30 in 2016, IPO 2007
odevixibat, potent, non-systemic ileal bile acid transport inhibitor (IBATi) that has has minimal systemic exposure and acts locally in the small intestine.
Phase 3 Study 402 lumateperone as adjunctive therapy to lithium or valproate for major depressive episodes associated with Bipolar disorder. The high dose met the primary endpoint for improvement in depression. The company followed up with a public offering of $350m. Shares closed the week up 53% to $27.65.
$AGRX 130k shares option executions and non-open market acquisitions.
Most people at OrbiMed and OrbiMed Asia does not have PhD. At most Master in Science.
$AKCA acquired all remaining shares of Akcea. No real gain since IPO, similar to $IONS in the same period. A marketing company.
$GILD licensed its JTX-1811 mAb anti-CCR8 to deplete immunosuppressive tumor-infiltrating T regulatory (TITR) cells. $85M upfront + $35M equity + $685M milestone.
On Thursday, a three-judge panel of the United States Court of Appeals for the Federal Circuit upheld a March federal court ruling that will allow Hikma Pharmaceuticals (ticker: HKMPF) to sell a generic version of Amarin’s (AMRN) fish oil drug, called vascepa. was $20+ for more than a year since good Ph3 results and later approval. Patent issue down to $4.
previous delayed CaPre (highly purified omega-3 phospholipid concentrate derived from krill oil) TRILOGY 2 Ph3 trial results released fail. $AMRN competitor. Both Ph3 failed. down to $0.24. was $40 in 2013
Ph3 failure cardiovascular trial for vadadustat (HIF prolyl-hydroxylase inhibitor, 马宇) for anemia due to chronic kidney disease (CKD), back to <$3
Nestlé buyout for $34.50 about 2.3B, lower than alltime high of $40. Post approval sell off to $10 $DBVT
panic sell off. $DVAX closed last gap @4.93, low overran to $4.52
#option: Oct 2020 $7 call original order 28@$0.35, chickened changed to 25@$0.40, did not patient enough to wait for overran. Day low $0.32- high $0.55, closed $0.42, not too bad. Contract range $0.20-5.70 (may be wrong)
高瓴invested 1.72亿人民币，call it 黑马 due to its native structure from Trimer-Tag tech.
2020.09.08 next trading day continue to decline; my article did not splash any rally
launch I Am So Done awareness unbranded campaign
commercial launched MyCapssa
veverimer CRL. non-absorbed polymer removes HCl from GI and blood. market cap $500M, $437M cash, early 2022. "magnitude and durability of the treatment effect of veverimer on the surrogate marker of serum bicarbonate and the applicability of the treatment effect to the U.S. population." "concern as to whether the demonstrated effect size would be reasonably likely to predict clinical benefit. "
Tlando oral Testosterone Replacement Therapy needs additional time beyond PDUFA. 2nd submission.
tesetaxel, orally administered taxane,Phase 3 CONTESSA trial for metastatic breast cancer (MBC) met the primary endpoint of improved PFS with median PFS of 9.8 months for tesetaxel plus a reduced dose of capecitabine vs 6.9 months for the approved dose of capecitabine alone, the improvement of 2.9 months was below expectations. side effects, neutropenia, a cause for a previous clinical hold, 71.2% for tesetaxel plus capecitabine vs 8.3% for capecitabine alone.
Phase 3 INSPIRE trial fail of IV rigosertib in higher-risk MDS (HR-MDS). 2013 IPO, 2016 1:10 2018 1:15 two reverse splits.
Phase 3 NORSE 1 trial fail of ONS-5010 (Ophthalmic Formulation of Bevacizumab, Avastin), for wet AMD, no improvement to Lucentis (ranibizumab). Ophthotech $OPTH. 2016 IPO peak $42, lost 98%
Phase 2 APOLLO trial fail of a RTGel hydrogel formulation + Botox (onabotulinumtoxinA) for overactive bladder (OAB) and urinary incontinence
new leadership announced. Paris, Bo Rode, Margrit all gone. Old folks promoted. New website no product anymore. Only partnering delivery tech. Back to scratch with 16% ownership.
Positive view from others: lower risk, less cash burn, perhaps more demand for its tech now?
deal with $ASMB to collaborate on Ph2 AB-729 + ABI-H0731 + NA combo to initiate 1H21
$MRNA CEO now talking abt IP issues: emphasizes that they invested a lot in tech... $ABUS
Enrolls Initial Patients (2/5) for First-in-Human CoreoGraft Study for coronary artery bypass grafting ("CABG") in Italy, popped up again
$GILD FDA CRL filgotinib (selective JAK1 inhibitor), for rheumatoid arthritis (RA). The FDA has requested data from their MANTA and MANTA-RAy studies before completing its review of the NDA. The MANTA and MANTA-RAy studies are designed to assess the effect of filgotinib on sperm. The FDA also expressed concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose. Data from the MANTA and MANTA-RAy studies are due in the first half of 2021. Galapagos shares closed the week down 26% to $117.30 while Gillead shares fell 3% to $66.50.Down 50% from $274 February 2020 to $137.
Poseida 2020.07 IPO P-PSMA-101 Ph1 trial clinical hold due to death from hepatic failure
ridding bodies of senescent cells for ageing. Ph2 UBX0101 for moderate-to-severe painful osteoarthritis (OA) of the knee failed. Down to $3 from peak $22.
buyout by $JNJ. M254 Hypersialylated IgG. 60% premium from my previous note
FDA CRLed valoctocogene roxaparvovec (AAV5 gene therapy for Hemophilia A) on durability concerns. Redose may be needed but AAV5 cannot be redosed. LNP can $ABUS
announced 2 additional 1-year follow up VenoValve patient. Now 8 completed 1-year, 7 success, 1 occluded due to fail to comply to anticoagulant dosing. 3 more coming before IDE filing planned in 1Q21 up 191% intraday, closed up 64%, 462M volume 38M shares outstanding
Dirk: Unmodified RNA. same tech as 20 years ago, 3 Ph1 candidates and MCap of 11B? Lead is CV8102 a TLR agonist ...
PIKA adjuvant (dsRNA poly IC based). Previously used in a Ph2 Rabies vaccine. See link. 投了。被我猜中。PolyIC做佐剂风险太大了。依生生物貌似做了很多年了，也许能在某些国家获批，在美国暂时没戏。建议大家别打。
Raise $12M secondary offering $3.60 per share, cash ~$22m only enough for a year.
up 15% on publication of reduced opioid use in 100 years
You are right. There was indeed separate news from SinoPharma chairman talking about Y400+ per dose, Y900+ two dose regimes. That is more than $60 per dose for a domestic made vaccine, or a "Made-in-China" vaccine.
How come a domestic-made vaccine more expensive than imported vaccine. That never happened in Chinese vaccine market. Nobody will pay for it.
new CMO Paul Korner MD, PHD from Axovant, SVP Clinical Development and Medical Affairs. CMO Elizabeth Garner left company in 07.2019 to join ObsEva as CMO
Buyout by Ligand ($LGND) for $12 or $438M +$2 or $78M CVR on predefined regulatory milestone by December 31, 2021.
FDA CMC CRL for Pedmark (Sodium Thiosulfate) for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients with solid tumors. -37%
-33% Omaveloxolone for Friedreich’s Ataxia, delayed from previous 1Q21 to "re-evaluated if it is required to conduct a second pivotal trial if the FDA deems its upcoming crossover trial to be insufficient for filing. Data from the trial are due next quarter."
Mesoblast, Ryoncil (remestemcel-L) cell therapy for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD), AdCom voted 8-2. Australian company.
Ryoncil (remestemcel-L) IV infusion culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. immunomodulatory.
down -48% Ph2 interim analysis no DUX4 expression separation from placebo.
2019 IPO, Fulcrum Therapeutics Losmapimod, p38α/β MAPK inhibitors as potent suppressors of DUX4 expression in treating FSHD (facioscapulohumeral muscular dystrophy).
Repurposed for COVID-19 to reduce inflammation
SER-109 Ph3 success surge from $4.64 to $33 intraday, purified bacterial spores of multiple Firmicute species manufactured by fractionating targeted bacteria from stool of healthy human donors with further steps to inactivate and remove potential pathogens.
2016 insider selling and crash. Don't have too much emotion attached. Things may change. But I should probably avoid.
Valneva didnot get MF59, only kept Dynavax CpG-1018
Q4 channel stock pile inventory revenue revised down to 1-2 million due to light inventory model. Does not mean anything about market acceptance. refill orders better price.
$MRNA admit patent risk
Partner deal with 极目生物 Arctic Vision (上海) for MicroPine MicroLine in Greater China and SK. 极目 also has deal with ClearSide. Up to a Total of $45.75 million, no upfront amount mentioned.
island reversal after meeting NASDAQ equity requirement
0.3m revenue, poor performance, still touting long term value. Enough cash for a year.
Big cap, sales rise 44% yoy to $463m. +24% day.
Mallinckrodt net loss of $933.1m, or $11.04 a share. Due to pressures from the Acthar Gel Medicaid matter, the ongoing opioid litigation and its current poor debt situation, bankruptcy under Chapter 11 likely.
Denali Therapeutics selected DNL151 for Ph3 Parkinson’s disease with $BIIB $560m upfront $465m equity. Up 36%. orally available, brain-penetrant inhibitor of the leucine-rich repeat kinase 2 (LRRK2)
$ACRX peer, FDA approved Olinvyk (oliceridine) novel μ Receptor G Protein Pathway Selective (μ-GPS) Modulator up 50% AH, CRLed in 2018 with $ACRX approval. market cap now three times $ACRX
as previous AdCom cancelled. FDA CRL requesting new human factor trial and supply additional Chemistry, Manufacturing and Controls data. Down from $48 peak to current $2.
FDA has approved Evrysdi (risdiplam) , the first at-home, orally administered treatment for spinal muscular atrophy (SMA) in adults and children 2 months and older.
FDA approved Epidiolex (cannabidiol) oral solution for seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. Up 4% on the news.
Down sharply -17% after earnings
PPAR agonist seladelpar success in primary biliary cholangitis (PBC), previously failed for NASH
|AGRX||condom sales down 50%, sex toys and contraceptive up 50%|
digital health clinic Nurx told USA Today that it has had a 50 percent rise in birth control requests and a 40 percent increase in emergency contraception orders.
release Ph1 data up 19% to $170.29. I checked nanoFlu data, Ph3 only compared to Fluzone, which was not the best approved vaccine. Had Flublok in Ph2, nanoFlu was numerically lower and had 2.5~4.5 times more SAEs.
Alzheimer drug accepted for accelerated review
Q2 ER: lesser of 20% received by Genevant, tiered low single digit royalties, 16% Genevant after equity dilution.
new HBV DNA positive cohort for 90mg to test DNA inhibition, $ABUS really taking its time to carefully evaluate options
729 1 year dosing planned.
2Q ER: Heplisav Revenue drop to 2.4M,
1: economics: too early, confident to meet supply goals.
Wait IBB pull back to 200mA and fill gaps, DVAX pull back and fill gaps, $BPHEAL and $CPC pull back
SD-101 sold to TriSalus with $9M upfront. TriSalus an intravascular pressure delivery company. Non-event. Byebye SD-101
leadership crisis: CFO left in Jan, CSO left in Mar, now CEO and Chairman both missing on Team page. $ABUS
tafasitamab (MOR208, formerly Xmab®5574) CD19 antibody licensed from Xencor in combination with lenalidomide approved FDA for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
TC-210 2/5 (40% ORR) in mesothelin-expressing solid tumors.
Dr. Elizabeth Nabel, president of Brigham and Women’s Hospital resign from BOD after cashing in $6.5Mil
patent issue Re: @MarkmanAdvisors
Avtive Learner @FAT2FIT7 Many cases have waited until the company succeeds and makes billions before asking for royalties
2019-1Q20 sold 13.5M shares for $31M ~$2.3/share
Data from recently completed NODE-301, Etripamil (fast-acting calcium channel blocker) Nasal Spray, and ongoing NODE-301B trial (renamed the RAPID study due late-2021/early 2022) can be used for future NDA, FDA meeting results. +133% weekly
6y 375X rise from $0.52 to $195 from 2009 bottom to 2015 top. Flat since.
PRS-343 is combining a CD137-specific Anticalin with a HER2-targeting antibody in a bispecific compound with the intent of trafficking an anti-CD137 therapeutic protein to the tumor microenvironment.
partial clinical hold by the FDA while Pieris conducts an additional in-use and compatibility study requested by the agency.
PSIC old candidate. Epic return from ruin. Flat since. around 20-40. Highest point 1y before FDA approval. Highest point for COVID vaccines probably between Ph3 success and FDA approval.
Ph3 failure of pimavanserin as an adjunctive treatment for major depressive disorder (MDD)
BXCL501 Selective α2a Adrenergic Receptor Agonist two Ph 3 success in neurology for schizophrenia (SERENITY I) and bipolar disorder (SERENITY II)
millions of new accounts opened at Robinhood and others. Retail investors rushing into market, will add to fuel next bubble.
USPTO ruled in favor of $ABUS on LNP patent '069, we suddenly have a Ph3 COVID vaccine and rest of $MRNA pipeline, can support HBV research, and dozens other LNP companies.
LNP Biotechs: CureVac, $GSK, $GRTS $ALNY $SGMO $CRSP $NTLA $GBIO $MRNA $RGLS $TBIO $BNTX $BEAM (&Verve)
Raise $10M at $1.06, increase total shares to 90M
Medigen collaboration PR. In preclinical testing, "generated strong virus neutralizing antibody responses and cellular immunity", only with Dynavax, no GSK
ThermoDox+RFA for HCC, beating dead cat, old hype in 2013 美股投资者运用医药知识做空克莱瑞恩全纪录 (ref), failed Ph3 again. 做空很难，不要羡慕
NC-318 (anti-Siglec-15) will not advance to stage 2 for NSCLC or Ovarian, "based on the current enrollment criteria and clinical response data. Continue for HNSCC". CMO departure.
up 20x for intranasal COVID-19 vaccine candidate, AdCOVID, just preclinical data so far.
speculation on patent dispute and Moderna COVID vaccine royalty coming to $ABUS.
"Until there is a product approaching the market that generates revenue, there is no reason for a patent holder to aggressively pursue litigation"
"100% of the (27) redactions are related to descriptions of the LNPs" in Moderna delayed publications.
Also speculation on $JNJ/$ARWR results, and $ASMB/$BGNE deal
#Checkmate IPO to raise $75mil after $85mil venture raise. $DVAX
$BGNE announce deal $40M upfront $500 milestones with $ASMB to develop and market its core/capsid inhibitors in Greater China. $ABUS competitor.
DVAX announced deal with Mount Sinai in developing universal flu vaccine influenza based on its chimeric hemagglutinin (cHA) tech, repeat 3 dose with same stalk but different head HA, direct immune boosting to otherwise subdominant stalk epitopes. HA silencing also allow immune response to other subdominant virus components such as NA. REF. REF2. REF3, Ph1 trial with AS03, combo w. NP, M1
Lots of study on CpG boostingtumor CD8 response. Hard to compare to $NVAX Saponin Matrix tech.
Other Universal Flu vaccines:
Morgan Stanley files 13G holding 3.5M share with 5.1%, so total 68.6M shares
min Mcap 2.99B, medium 5.16B
penny stock acquired Kiq LLC, a biotech focused on precision kinase inhibitors, private placement of $104.4M +655% to $3.32.
Upneeq (oxymetazoline hydrochloride ophthalmic solution eye drop), 0.1%, formerly known as RVL-1201, its novel treatment for acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid that can limit field of vision. Upneeq becomes the only FDA-approved medical treatment for ptosis. Not its Osmodex technology.
Linzagolix (OBE2109) Oral GnRH receptor antagonist, released 2nd h3 75.5% response rate, much lower than 93.9% previous Ph3 trial. High placebo rate put it the lowest placebo adjusted response rate. Safey my give it some advantage. Investors and analysts worried about its competitiveness against Abbvie and Myovant
BLU-5937 a highly selective P2X3 antagonist for chronic cough and chronic pruritus. P2X3 is a key sensory receptor, responsible for irritation and pain, in the cough reflex pathway.
Ph1/2 trial of OTO-313 (sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine) for persistent tinnitus exhibited responder rates of 43% at both Day 29 and Day 57 compared to 13% of placebo patients. up 33%, still way below IPO
up week 10% on Ph3 data Trodelvy (Sacituzumab govitecan) in TNBC, PFS 5.6 vs 1.7, HR 0.41, early approval in April.
CEPI invest $66m upfront in Clover COVID-19 vaccine
tech bubble $TSLA almost quarupled $AMZN almost doubled since March bottom.
company project 5-8% TRx market share, 1% TRx share translates to $200M sales. 1.0-1.6B sales, 5X P/S due to pipeline, 5-8B MCap buyout, $50-80/share.
added to Russell 2000 & 3000 indexes
2020.07.04 FDA noted deficiencies that preclude discussion of labelling and post-marketing requirements/commitments for VP-102, for molluscum contagiosum. -27% week
HTX-011 ((bupivacaine and meloxicam)) for the management of post-operative pain, citing non-clinical issues. There are four non-clinical issues in the CRL, none of which relate to any observed toxicity. Three relate to confirming exposure of excipients in preclinical reproductive toxicology studies, and the fourth relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage. We do not believe that any of the issues are significant barriers to ultimate approval, as all of the excipients have extensive histories of use in pharmaceuticals and the specification can be revised.
$PCRX competitor (with Exparel) non-opioid pain management +19% to $52 on the news.
AdCom delayed twice and cancelled. obeticholic acid (OCA) for fibrosis due to nonalcoholic steatohepatitis (NASH). FDA rejected the drug because they were uncertain if the surrogate endpoint from their Phase III trial — reduction in liver fibrosis — would actually translate into benefit for patients. The FDA invited them to re-submit with longer term data from the Phase III trial. Company complain about "evolving" guidelines.
$77 -> $48. Wiped $1B market cap. On 2014.1.9 morning, the company PR said OCA trial stopped early "for Efficacy Based on Highly Statistically Significant Improvement in Liver Histology. from $72 to $497 in two days. Decline ever since. Eventually gap filled.
Dojolvi FDA approved, is a highly purified, pharmaceutical-grade, odd-carbon medium-chain triglyceride consisting of three 7-carbon fatty acids on a glycerol backbone created via a multi-step chemical process. It is designed to provide medium-chain, odd-carbon fatty acids as an energy source and metabolite replacement for people with long-chain fatty acid oxidation disorders LC-FAOD, a heterogeneous genetic disease.
3month 9X return after IPO $25 -> $235, pull back to $55 in 8 months
famous cannabinoid stock bubbled in the 2H2018 from $25 -> $150 in 2 months after IPO. declining to < $4 ever since. $CGC $ACB 2X same time, now all way below pre-bubble price.
Ph2/3 Zygel CBD gel for behavioral symptoms of Fragile X syndrome (FXS) failed. $GWPH #Cannabinoid
Further data release on efruxifermin AKR-001 long acting fibroblast growth factor 21 (FGF21) for NASH. +40% week. 2019.06 IPO
HDAC inhibitor (Ph3, Pracinostat+Vidaza for AML) discontinued unlikely to meet the primary endpoint of overall survival.
offering $70M at $4
$BNTX BioNTech's latest S1 says a rare disease drug partnered with Genevant will enter the clinic in 1H 2021.
awarded HepB vaccine $27M CDC contract
Astellas acquired Audentes. AT132 (resamirigene bilparvovec) in the treatment of X-linked myotubular myopathy (XLMTM) 2nd death, put on hold. New concern on AAV (AAV8 gene therapy)
5th vaccine with Medigen vaccine biologics corp. 中国台湾
$ACRX chairman Adams Adrian 100k shares @$1.29 CEO 7547 shares @$1.33
Melinta did not win Tetraphase, it is $LJPC who came back again and won with $44M cash and CVR
discontinued Nevanimibe (ATR-101) is an ACAT1 inhibitor for classic congenital adrenal hyperplasia (CAH)
Vecabrutinib (Oral covalent BTK Kinase Inhibitor) discontinued for rrCLL due to lack of efficacy.
up 14% Ph3 trial of once-daily relugolix (small molecule, gonadotropin-releasing hormone (GnRH) receptor antagonist) combination therapy in women with pain associated with endometriosis, met endpts.
deal with CSL Behring for etranacogene dezaparvovec (AAV5-FIX-Padua), its gene therapy for hemophilia B. $450M upfront + $1.6B milestone. Close down 22% as hopes diminished of a buyout of the company.
expanded deal with Sanofi to develop mRNA vaccines for infectious diseases. $425 upfront ($300M cash + $125M equity @$25.59) also raise $125M.
Fintepla approved by FDA-9% sell off on news.
to be delisted from Nasdaq on 6.29
MyCapssa approved by FDA, no action AH. Not much since trial results announcement. 11month 6X rise prior that. Commercial?
6.26 Russel rebalance. Large volume expected, don't interpret too much.
Michael Sofia talk: lack of urgency, lack of clear path forward (unlike HCV was clear dropping viral load works) -> lack of investment
Q: only 30-40 on drug watch: what would be the breakthrough? A: no relavant biomarkers predictive.
$GILD $275M for 49.9% for its TREM1 TREM2 I/O pipeline. Option to buy the rest for $315M
斥巨资$300M购买 GNC 可转换优先股; 已减记 11 亿元人民币。并购海外无前景无技术垃圾公司
after 34 years of failure, 1:15 reverse split in 2019.02, one year flat base around $2-3, cup with long handle. CellDex delivered some positive news on KIT inhibitor CDX-0159: Dose-dependent Reductions in Plasma Tryptase—an Indicator of Mast Cell Burden—and a Favorable Safety Profile.
Microcap+ (>50m) Biotech Belowcash
17 <=1; 81<=2 (541 Biotech); price 144 <=3
24: Y+500% 9:
$MYL challenged Biogen’s ‘514 patent for its multiple sclerosis drug Tecfidera (Dimethyl fumarate) is ruled by a U.S. District Court as invalid due to "lack of written description."
A 2019.11 BelowCash candidate, deal with $GSK for Synthetic Lethality programs MAT2A, Pol Theta, and Werner Helicase programs. $100m upfront and $20m equity. GSK is focused on synthetic lethality and SF bay area.
Key to 2019 IPO Ideaya’s success would be the precise segmentation of patients using molecular diagnostics
A first-in-class dual CD28/ICOS antagonist (vIgD tech), Phase 2-ready drug for systemic lupus erythematosus and Multiple Inflammatory Disease Indications. $60M upfront + $805M milestone.
Was Nivalis (Cystic Fibrosis) 2015 IPO ($15, $60 post split, ended ~$9), failed (S-nitrosoglutathione reductase (GSNOR) inhibitor cavosonstat) in YE2016, Dendreon CEO Mitch Gold startup Alpine Acquired Nivalis in 2017.04, reverse split in 2017.07 ~$9, COVID-19 low $2.05 (2.5 years since merger), lost 75% since. Back to $12 with this deal.
Verzenio (abemaciclib, CDK4&6 inhibitor, approved in 2017 for certain breast cancer) Ph3 in combination with standard adjuvant endocrine therapy (ET), met the primary endpoint of invasive disease-free survival (IDFS), significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant ET alone. Shares closed Tuesday up 16% to $163.71.
2nd CRL due to unable to inspect EU facility CMC amid COVID-19 travel restriction. Resubmitted 12.20.2019 for 6m review. Lost 90% since IPO.
sNDA FDA approval Crysvita (burosumab) for fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia (TIO).
FDA approved sNDA Tazverik (tazemetostat) in patients with relapsed or refractory follicular lymphoma.
Gimoti FDA approval. intranasal formulation of metoclopramide, for acute and recurrent diabetic gastroparesis
Ph3 once-daily Diazoxide Choline Controlled Release (DCCR) tablets for Prader-Willi Syndrome (PWS) miss endpoint.
Viela Bio (MedImmune Spinout) IPO 2019.10 FDA approval Uplizna (inebilizumab-cdon) anti-CD19 IV injection for neuromyelitis optica spectrum disorder (NMOSD). who are anti-aquaporin-4 or AQP4 antibody positive.
Blackstone Life Sciences to invest $300m in return for royalty payments on worldwide net sales of bardoxolone, chronic kidney disease in Alport syndrome and autosomal dominant polycystic kidney disease. Additional $50m equity at $146.72
REGN-COV2 dual antibody cocktail initiate trial four separate study populations: two for treatment and two for prevention.
two antibodies bind non-competitively to the critical receptor binding domain (RBD) of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment. Two science paper on preclinical research.
pulled back to my recent add price ($1.84), low $1.75, always more opportunities. 11 week + 3 week cup and handle
Series C financing $85M, IPO coming? Decheng Capital, Katherine Xu as Partner
IBB FBIOX XBI:XLK finding support the first time since 2015
OP0201 in acute otitis media (study C-006) did not meet the primary endpoint.
OP0201 is being developed as a potential first-in-class treatment option for OM. OM is often caused by Eustachian tube dysfunction (ETD). OP0201 is a nasal aerosol, drug-device combination product comprised of a novel formulation of a surfactant (dipalmitoylphosphatidylcholine [DPPC]) and a spreading agent (cholesteryl palmitate [CP]) suspended in propellant. The product is administered intranasally via a pressurized metered-dose inhaler (pMDI).
Phase 3 trial of OCU300 (brimonidine (an α2 adrenergic agonist) 0.18% nanoemulsion) for ocular Graft vs. Host Disease (oGVHD) discontinued for futility at interim. Penny stock
preliminary results for first 10 patients, 1 stable 9 progression. But company think encouraging saying tumor shrinking. tilsotolimod in combination with Opdivo® (nivolumab) and Yervoy®* (ipilimumab) in immunotherapy-naive micro-satellite stable colorectal cancer (MSS-CRC)
sulopenem failed non-inferiority relative to ertapenem (named Invanz by Merck & Co.) in its trial in patients with complicated urinary tract infection (cUTI) (discovered by Pfizer in 1980s and abandoned due to lack of commercial potential), Licensed by Iterum in 2015
2018 IPO lost 90% value
Mereo $70m private placement complicated deal equity $1.1/share+loan+warrants. Etigilimab (Anti-TIGIT)
shy away from $TTPH after increasing offer 2 times. Keep co-promotion. Pocket $1.8M break-up fee. "Financial disciplined".
more murky data on Remdesivir $5k per round
to merge with Catheter Precision, Inc., a private medical device company focused on cardiovascular diseases, including heart arrythmias. software imaging system called VIVO™
Low cash was the problem.
increased offer 30% to buy $TTPH from 0.6303 $ACRX/$TTPH to 0.7217 + $0.2434 cash per share. $12.5MCVR to $14.5M. Intraday down -10%
2020.05.29 increased offer to 0.7409 /share + $0.5872 cash + $16MCVR
2020.06.01 Melinta increased offer to $39mil cash + 16mil CVR. $ACRX stock tanking, cannot compete.
offering 14mil shares at $5 to raise $70mil, 15% overlot. Right after COVID-19 jump. Fill the gap.
21 <=1; 84<=2 (537 Biotech); price 148 <=$3
Microcap+ (>50m) Biotech Belowcash
LXRX $1.91 204 SGLT2 SGLT1 dual inhibitor sotagliflozin CRL after 8-8 split AdCom, initial up after Sanofi terminated. Then down below cash.
Deal with $GILD $174 upfront and $200m equity. fall 12% week as investors hoped a buyout. was #Belowcash
Efgartigimod anti-FcRn (neonatal) Ph3 success in generalized myasthenia gravis (gMG) 11X 3 years. Straight success from IPO in 3 years.
XMT-1536 ADC targeting NaPi2b, better than Genentech Ph1 interim data success in ovarian cancer. 2/20 CR 5/20 PR 35% ORR. Was #BelowCash now 15X in 7 months
Roluperidone Ph3 for schizophrenia failed.
Arvinas IPO in 2018.09 3x peak, now 2x. -26% Ph1/2 ARV-110 dose escalation in metastatic castration-resistant prostate cancer (mCRPC). Only 2/20 saw PSA level drop >50%. #E3ligase Vividion
ADP-A2M4 SPEAR T cells targeting MAGE-A4 cancer testis antigen. Ph1 success 50% 8/16 synovial sarcoma PR. Was #BelowCash 15X in 0.5y
$DVAX collaborator interviewed by SkyNews, in talk with European countries for Ph3 trial.
announce plan to manufacture 1B dose adjuvant $DVAX
back manufacturing of COVID-19 vaccine developed by Luk Vandenberghe Massachusetts Eye and Ear and Massachusetts General Hospital. AAV vector, better than Adevovirus
Johnny asked me. My A: has a scientists team from Scripps and a hot platform (E3 ligase). There are some competitors Arvinas, Nurix and BeyondSpring. Vividion just received $135 mil from Roche, which is a big thumb up from Big Pharma and a decent amount of cash for financial security.
risk to delist is high, no signs of improvement, ready for OTCBB? CFO resigned.
enter COVID-19 vaccine game with buyout of Austrian firm Vienna-based Themis (+Chikungunya vaccine), collaborate with nonprofit IAVI for a rVSV COVID19 vaccine (the basis for Merck’s successful Ebola Zaire virus vaccine). deal with Ridgeback Biotherapeutics on an early-stage antiviral EIDD-2801
Grunenthal terminates Zalviso EU deal, effective 11.14.2020. $ACRX next day agreed to provide a right of first negotiation (“ROFN”) for a license agreement to replace the Grünenthal License Agreement to a third party with which the Company is currently negotiating a license agreement for DZUVEO for the European market.
$TTPH it is funny to say an all-cash offer is "superior" to an all-stock offer in such market condition. I guess the Board thinks its asset has no future value, all they want is cash-out. Or they are just begging $ACRX for more?
To match $27M cash offer from $MLNT Melinta (a delisted, bankrupted and restructured company), $ACRX needs $1.93
AdCom for obeticholic acid (OCA 奥贝胆酸) for liver fibrosis due to nonalcoholic steatohepatitis (NASH) postponed anticipating additional data submission. A marketed drug.
E2112 Entinostat + Exemestane vs Exemestane alone no difference in HR+ HER2- breast cancer
$GILD collab Phase 2b/3 SELECTION trial filgotinib in moderately to severely active ulcerative colitis (UC). 200mg met not 100mg.
KD025, belumosudil, an oral selective inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2) Ph3 success in cGVHD with at least two prior lines of systemic therapy. 73-74% response. better than Fed readout. NDA in 4Q20.
licensee Sunovion FDA approval for apomorphine sublingual film for OFF episodes with Parkinson's disease (PD) 2019.02 CRL
$AGRX: 126K shares #insider direct buy from three officials. in Feb-Mar
#Genevant CSO Margrit Schwarz left for COO at Draupnir Bio after 14 month. 2~3 programs in clinic by 2020.
hype its neutralizing antibody for COVID-19 as an IV infusion cure. Stock from 2.6 to $10, called upon Fox news and business reporters, "requires fast FDA approval". Only in vitro. Hardly any news, many companies have neutralizing antibodies and way ahead.
SEC filing after hours one or more COVID-19 vaccine using CpG-1018 will enter clinical trials by July up 50% AH
1. added 2k 1125 shares @$1.8144 fill gap order, filled in a flash close gap shakeout before the big news of 60mg. perfect order: gap at 1.84, put limit order @1.80 day low was $1.76 so close!
release data "grade 3 systemic symptoms...following the second dose" Notes: 1) requires two doses 2) immune reaction to repeated dosing 3) bad in-house LNP, better pay $ABUS for better LNP to protect mRNA 4) LNP may break apart in muscle route
$PFE DMD PF-06939926 AAV-dystrophin show serious immune reaction. $SRPT SRP9001 is better. Up 11%. MCap hover around $11B. LNP $ABUS?
Ph3 RESOLVE-IT elafibranor (GFT505, PPARα/δ agonist) failed in NASH, down 74% week. $CBAY failed a year ago.
$PTIE, -74% on failure Ph2b PTI-125 in Alzheimer's disease, really bad history since $PTIE era.
Omidubicel Ph3 for BMT success. consists of NAM-expanded cord blood hematopoietic stem cells and differentiated immune cells, includingT cells. up 44% week.
a muscle company, mediocre stock performance, CK-274 similar MOA to $MYOK mavacamten for HCM, Ph1 due 2H2020, way behind, up 37% week on $MYOK news
After sideways for 3 years, Phase 3 pivotal EXPLORER-HCM trial of mavacamten for symptomatic, obstructive hypertrophic cardiomyopathy (HCM), met the primary and all secondary endpoints. Up 99% week. 10X in 3 years. 5.7B MCap. No failures.
ALLO-501 is an anti-CD19 allogeneic CAR T (AlloCAR T™) for relapsed/refractory non-Hodgkin lymphoma (NHL). #ASCO20 abstract ORR 78% already 5.6B MCap
Rubraca PARP inhibitor approved for new indication sNDA metastatic castration-resistant prostate cancer (mCRPC)
QINLOCK (ripretinib, DCC-2618 dual KIT PDGFRa inhibitor) for gastrointestinal stromal tumor (GIST) – FDA APPROVED
1Q20: $5.4m private placement, Senju license, COVID-19 delay
DOD order about $30m in 3 years.
1Q20 CC: EMA submitted, will benefit from COVID-19 in the travel market, trials intact, to complete in 4Q
1Q20 CC: 1. Remain on track despite COVID-19, data expect 2Q and 2H20
$MRK Nuvaring global sales from 2017-19: $761 $902 $879M, sub $1B product. I expect Twirla to replace Ortho Evra (Xulane) and take a same size market as Nuvaring, making it a $1B product due to its unique formulation. Company projections have been very conservative. Considering its pipeline, a $3-5B buyout not just a dream. $30-50/shr.
vadadustat (HIF prolyl-hydroxylase inhibitor) Phase 3 INNO2VATE trial success for anemia due to chronic kidney disease (CKD) in adult patients on dialysis. Decline since I heard from 马宇
Phase 3 UNITY-CLL trial combination of umbralisib (PI3Kd inhibitor) plus ublituximab (anti-CD20) compared to obinutuzumab (Roche anti-CD20) plus chlorambucil (Chemo) in previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL) success on PFS.
sold to private Italian company Menarini Group upon poor revenue performance of ELZONRIS (anti-IL3R CD123) poor IPO return
$TTPH which agreed to merge in an all-stock deal with $ACRX on 03.26. Received unsolicited offer from loser $LJPC, slightly better. +53% on the week speculating bidding war. Not really any better. Traders have no clue on the deals.
to present at ASCO Ph1 MGD-013 data in solid tumor. A cohort of advanced HER2+ treated with MGD-013 (PD1xLAG3 BiTE) + margetuximab achieved 40%+ ORR
1Q20 revenue 10.5mil, impact from 3.15 COVID-19 closure, will continue rest of year.
acquired by ALXN, Andexxa, poor sales, a Factor Xa inhibitor reversal agent that will mark a change in focus for Alexion, was $66 when hope was high, MCap $4.4B, decline down to $5.31, now buyout $18 at $1.4B
Phase 2/3 ADVANCE-1 AXS-05 trial success, significantly improving agitation in Alzheimer’s disease. NMDA receptor antagonist with multimodal activity under development for the treatment of CNS disorders.
SNDX-5613 small molecule inhibitor of Menin-MLL binding for MLL-rearranged leukemias (ALL & AML). Ph1 2/3 ORR (1PR1CR) +55% week
Phase 3 Voyager trial of avapritinib in locally advanced unresectable or metastatic gastrointestinal stromal tumor (GIST) did not meet the primary endpoint of an improvement in progression-free survival (PFS) versus regorafenib. -19% week.
Tivozanib final OS data to be presented at ASCO, FDA has repeatedly said this data is required for any consideration. Interim data in Nov 2019 was note enough. Europe conditional approval also depends on this.
10-year partnership with Lonza to begin manufacture its unproven vaccine mRNA-1273 in 2020.07 and up to 1b dose per year. Got the most government funding and most hype. Will it deliver? How about $ABUS
Partner with Atreca ($BCEL, 2019 IPO $380M) IGM Biosciences ($IGMS 2019 IPO $1.66B) for COVID-19 antibodies: $BCEL discovery from patient B cells, $IGMS develop and manufacture IgM and IgA antibodies, $BGNE clinical development global. Financial terms later.
announce milestone C approval, military order to come in later this year and beyond. $0.4M Q1 sales. COVID-19 to delay REMS, formulary approvals and reduce revenue.
China to punish $LK fraud.
announce positive news from NIH run trial. Twitter debates on re-opening. Sell-on-news due?
to partner out its anti-CD47
Interim Analysis of Ongoing Clinical Trial Evaluating HEPLISAV-B in Patients Undergoing Hemodialysis, well tolerated with a seroprotection rate of 86.4% (n=44). Reduce from 8-dose to 4-dose
$REGN $SNY IL-6 drug Kevzara didnot work in moderate patient, maybe some effect in severe patient. $RHBBY Actemra boasts anecdotal positive news from France
$BMY Ph3 success evaluating Opdivo + Cabometyx vs sunitinib in previously untreated advanced or metastatic renal cell carcinoma (RCC), PFS, OS, ORR
Trodelvy (Sacituzumab govitecan) received early approval for TNBC after previous CMC CRL. 1st product in 37 years history.
BLA filing of aducanumab for Alzheimer's disease delayed from early 2020 to 3Q20. -13% week. COVID-19 scandal.
$MRNA IPR patent dispute zoom debate on 4.22 arguing over obviousness and prior art on overlapping ranges. Similar to '435 patent dispute, '435 all LNP claims invalidated.
3rd collaboration (with SinoVac科兴生物 尹卫东 潘爱华 美国退市) on COVID-19 vaccine, it seems an adjuvant is needed for 3 different vaccine design. Weak immunogenicity? Poor rates in MERS SARS vaccine
4.19 The #lopinavir study just published illustrated that unblinded studies can lead to bias + early hospital release. #STATNews article may bias ongoing trial.
Conclusion: market downturn after Redemsivir proven to be a hype or mediocre data release.
Dr. Derek Lowe analysis of STATNews leak
CytoDyn ($1B MCap) HIV drug CCR5 antagonist Leronlimab post 1 patient COVID-19 anacdotal results. Hype?
ME-401, an oral PI3K delta inhibitor, deal with Kyowa Kirin Co., for B-cell malignancies. $100M upfront. Other pipeline: HDAC (Ph3, Pracinostat. Vidaza for AML), CDK, mitochondria inhibitors. San Diego based. 2012 1:6 reverse split
Previously synthetic biology hotshot Intrexon ($XON) failed with too many pies in the sky. Pop at $65 in the 2015 bubble. GOing down since. Now $3. Bought CAR-T company Precigen, later refocus everything on it and took its name and CEO.
Ph2 failure of AG013 (genetically engineered bacterial strains #microbiome) in oral mucositis in chemoradiation in head and neck cancer
2013 list on NYSE from OTCBB, had two OTC Probiotics products, 2018 reverse split 1:10, licensed from Intrexon ($XON), which is another failure itself.
Arcus Biosciences, rich cancer pipeline including:
Zika vaccine 1.0 ineffective. Andrew Lo cited 33% vaccine success rate, proposed new business model and government to support vaccine development by buying at early stage. But traditional vaccine is not mRNA vaccine.
1. Advantage: multiple mRNA at the same time, COVID-19 only 1, complex antigen, combination vaccine; T cell response; Fast development; Lower Capex
STATNews report anecdotal Remdesivir Chicago arm results. 125 enrolled 113 severe arm patients, most discharged, 2 death, much better than compassionate use results. Even though Gilead will NOT sell it for profit, investors still super positive. up10% heavy volume. Lack of controlled arm, yet some claim the docs' positive attitude may not be discounted.
Analysts assigned the rise of $15-35B Mcap to Remdesivir is non-sense. Stock long consolidation after Sovaldi is over, due to rise.
BARDA bets $484M for fast Ph3 vaccine from Moderna $ABUS
two dose ESC+ modified VIR-2218 shows about 1-log HBsAg reduction. claim better than parent drug ALN-HBV, expect sell off with 35X MCap.
$ABUS 259-page (I downloaded) mRNA vaccines day presentation shows Moderna is completely dependent on LNP. No wonder so much legal fight.
galidesivir, a adenosine analog, broad spectrum anti-viral drug, former HCV candidate, subsequently developed for deadly filovirus infections such as Ebola virus disease and Marburg virus disease. Now enrolling for COVID-19
init human trial after $MRNA, CanSino
Serlopitant, NK1-R antagonist, fails pruritus associated with prurigo nodularis. Peak after IPO $38 Now $1.2
#endocrine 2018.09 reverse merge with OvaScience.
Ph3 trial Sacituzumab govitecan for Triple-negative breast cancer (TNBC) halted due to compelling evidence of efficacy. up week 109%,
early non-controlled compassionate use data released, far from perfect, not everyone respond, plenty toxicity. More controlled trial data due late April, May. Wuhan trial stopped due to lack of enrollment.
Ph3 STRIDE-1 trial of AXS-05 for treatment resistant depression (TRD) fail.
$ARWR drop from $74 to $20, also closed major gaps.
stopped bardoxolone methyl (bardoxolone) Ph3 trial for connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) due to high risk to COVID-19. DSMB also suggests initial efficacy analysis indicates unlikely to met primary endpoints.
patent invalidated as "obvious". will appeal. Data shows EPA OMEGA-3 level is directly related to CV risk reduction, not Triglycerides
Stock back to pre success level from $26 back to $4
deal with Janssen ($JNJ) for CAR NK and T cell off-the-shelf therapy. $50m cash +$50m equity + $3B milestones
AKR-001 long acting fibroblast growth factor 21 (FGF21) from 1~2 days to 3-3.5 days for NASH. Show Ph2a success +24% week
$PG rise too much due big drop 30-50%
$UN due 50% drop
$XLF already lost 50%, $WFC already more than 50%
6 COVID-19 patients all responded to anti-GMCSFR Mavrilimumab in Italy. Up 43% week. 2018 IPO. Based on Chinese Research.IMAB and Roivant also pursuing anti-GMCSF.
partnership with Biomedical Advanced Research and Development Authority (BARDA) in COVID-19. trial in 2020.09. up 9% week
withdraw guidance due to COVID-19
IntelGenx Tech FDA CRL. RIZAPORT® is the first rizatriptan oral disintegrating film for the treatment of migraines to achieve E.U. marketing approval.
Ph3 nanoflu vaccine success. More antibodies against wild type Influenza which drifted from last year.
Sf9/BV recombinant tech to form stable nanoparticles
deal with Astellas for CD3 and tumor cell surface antigen for cancer. $80m upfront +$1.6B milestones.
FDA approved Zeposia (Ozanimod) for relapsing MS. COVID19 delays commercialization. Was $CELG fiasco.
propose to give vaccine to healthcare workers in Fall 2020, earlier than the previous 12-18 months timeline
rushed for orphan drug status for remdesivir, got criticized, handing it back
Ph3 NODE-301 Etripamil (fast-acting calcium channel blocker) Nasal Spray for paroxysmal supraventricular tachycardia (PSVT) miss endpoint: time to conversion of supraventricular tachycardia (SVT) to sinus rhythm (SR) compared to placebo. -84%. Was $27 post IPO in 2019.05. Now $2. Had famous VCs $80m in 2017.
obeticholic acid (OCA) in liver fibrosis AdCom delayed from 4.22 to 6.9. PDUFA stays the same as 6.26
AB-729 preliminary results, 180mg not safe, 60mg 29 day results not good. But strong potential of multidosing accumulative effect. 50% sell on news. It seems they are not in a hurry to do multiple dosing like $ARWR did. because capsid still far away.
04.04.2020 $0.93 gap filled
CLOVER 三叶草生物S-Trimmer (Trimmer-Tag) COVID-19 vaccine collaboration as adjuvant, previously tried $GSK 's AS03
private placement $6m @$2.21 per unit, include one share, 0.5 share 1y warrant of unknown price, 0.75 share 5y warrant of unknown price
FDA questions its peanut skin vaccine efficacy. APAC AdCom cancelled. -56%
isolated COVID-19 virus-neutralizing fully human antibodies. Select two for cocktail. Trial in early summer.
first patient dosed. mRNA-1273 for COVID-19. Ph2 in a few months.
oral enteric coated AAV (Ad5) delivers pathogen gene and TLR3 adjuvant to intestine to generate mucosal and systemic immunity. Signed deal with $EBS to develop COVID-19. Ph1 in early 2H20
teplizumab Ph3 delayed due to COVID-19
Zimura complement C5 inhibitor Zimura Ph3 delayed due to COVID-19
BNT162 mRNA-LNP vaccine for COVID-19 late April ready, global partners, up 100% in two days.
03.21 closed week $46.50 after intra-day high Wed $105
04.22 approval from Germany to commence human trial, US soon.
|ACRX||merge with Tetraphase (antibiotics) in an all stock deal||2020-03-16|
Sunesis Vecabrutinib (SNS-062): An Oral covalent BTK Kinase Inhibitor for CLL lack ORR downgraded from 20% to 5% success by Wells Fargo
DE-122 (carotuximab) anti-endoglin for angiogenesis, failed wAMD and discontinued.
discontinued development of RTX-134 (red cell expressing enzyme) for phenylketonuria (PKU). Cells are not detected.
2018 IPO was $26, now <$4 MCap $300M
lead: IND enabled. RTX-240 co-expresses 4-1BBL and IL-15TP, a fusion of IL-15 and IL-15 receptor alpha, with the goal of improving anti-tumor activity and overcoming resistance to immunotherapy in patients with solid tumors.
KPI-121 0.25% (loteprednol etabonate) is an ophthalmic corticosteroid formulation for dry eye, 3rd Ph3 success. To resubmit NDA. Small cap $240M. 2018 IPO $19. Now around $4.
huge debt, losing lots of money, Guide 55-62m for 2020, up 70%, pertussis and other research initiatives
confirms type C meeting in April
Phase 1 trial of OTX-TKI showed favorable early activity. Analyst upgrade PT $7 to $15
Xpovio (selinexor) Ph3 success in multiple myeloma
INO-4800 ready for trial in April for COVID-19, similar promises for Zika, MERS, Yellow fever, never brought any to market. +229% weekly
treatment for COVID-19 ready by August for trials. Up 50% since Jan in a month
MSC so prominent, Jennifer Chia also agrees it's shady
announces collaboration with University of Queensland to provide CpG-1018 for COVID-19 vaccine development
Fintepla PDUFA extended 3m to 06/25/2020
Serlopitant, NK1-R antagonist, fails chronic pruritus (itch) of unknown origin (CPUO)
$GILD takeover offer now $58
tumor infiltrating lymphocytes ex vivo expansion tech, 24% CR 56% ORR in metastatic melanoma. Exploring sale of company. $1 in 2013, $5 in 2016 now $31
$350 deal with $BIIB ($125M fee+$225 equity) for genome regulation of Tau and Synuclein by Zinc-finger AAV mediated TFs. Was $23/share in 2018 then setbacks of mediocre data now $8
private offering of $65m ADS. Up 32%.
after analyst raise PT, then came offering.
HTX-011 PDUFA postponed 3 months due to CMC issue.
reverse merged with Forte Biosciences
FDA approved Nexletol (bempedoic acid) for LDL, closed down on safety info on label.
FDA approved Anjeso (meloxicam injection) for pain.
to present 8-patient data at meeting. to file IDE in 3Q2020 for pivotal study in USA
mRNA-1273 anti-COVID-19 vaccine ready for human testing
market fall sharply on coronavirus fear, $VIX spikes. Market rally was over extended, $CPC low, gapindex bearish
issue 15mil shares @$3 with 2.25m overlot, considering 1.4mil warrants, total shares now 88.6+10m options, almost 100m, may need to down adjust target value if more dilution coming.
49 <= 1； 117<=2; (560 biotech); price 158 <= $3
$CCXI C5aR inhibitor
$KOD Antibody Biopolymer Conjugate (ABC) of anti-VEGF
$ADVM ADVM-022 gene therapy for anti-VEGF had clinical issues but still climbing back break out cup-with-handle
$RCEL see previous
$PRVB diabetes drug, see previous, continue to rise after pull back to 200ma
$RLMD neurology NMDA for depression. continue to rise after jump
$APTO rise on ASH19 preclinical data of Flt3/BTK CXCR4 drugs
sold bermekimab to JNJ for $750M cash + milestones + manufacture and clinical collaboration. Dutch auction to return $420m to investors
clinical hold on IND of LB-001 for methylmalonic acidemia (MMA) asking more data. 2018 IPO gene therapy
-12% Phase 3 trial of troriluzole (modulates glutamate) failed Generalized Anxiety Disorder (GAD). eyes on Ph 3 migraine trial.
Part 2 of the Phase 2 Simplici-T1 trial evaluating TTP399 oral small molecule, liver selective glucokinase activator as an oral adjunctive therapy to insulin in adults with type 1 diabetes (T1D) achieved its primary objective by demonstrating statistically significant improvements in HbA1c (long-term blood sugar) compared to placebo at week 12 (p=0.03). Shares closed the week up 38% to $2.90.
CaPre TRILOGY 2 trial data delayed from Feb to 3Q20, to wait for discussion of failed TRILOGY 1 trial results with FDA before unblinding 2nd trial -25% to 0.57
revenue positive surprise, mostly license and milestone, guidance higher as well
BioXCell founded in 2017, IPO in 2018.03, $4 in 2019, now target raised by SunTrust analyst from $25 to $150 purely on BXCL501 Selective α2a Adrenergic Receptor Agonist, opioid withdrawal and schizophrenia success speculation. Pump?
BioXcel soars after SunTrust more than sextuples price target to $150 Shares of BioXcel Therapeutics are soaring after SunTrust Robinson Humphrey analyst Robyn Karnauskas more than sextupled her price target on the shares to $150 from $24. The stock in premarket trading is up 74%, or $17.60, to $41.45. The rarely seen target quintuple came after the analyst did greater due diligence and added sales for opioid withdrawal, adjusted the company's dementia/schizophrenia/bipolar sales to more accurately reflect the market opportunity, and adjusted its operating expenses to more accurately reflect sales synergies and lower R&D costs. With two pivotal trials and two Phase 2 trials this year, "investors are missing how quickly these datasets will come and also how quickly the company can complete additional Phase 3 trials," Karnauskas tells investors in a research note. She believes the opioid withdrawal market represents a meaningful opportunity with 18% of 2M patients seeking treatment. The analyst models $1B in unadjusted peak sales with a 50% probability for BXCL501. Further, Karnauskas believes BioXcel's pivotal Phase 3 trials in schizophrenia/bipolar will be successful and launch in the second half of 2021. She models $1.5B in peak sales for dementia with 30% market penetration. In addition, every additional 10% market penetration in schizophrenia/bipolar would add $17 to her discounted cash flow model and every additional 10% market penetration in dementia would add $2
2.13 bear raid to $2.75 closed gap at 3.09 in a flash drop.
2.14 another drop before FDA approval after hours. BMI > 30 NO. Now sell on news? How bad?
Broke above head and shoulder pattern, set initial $2k 2950 shares order limit at 0.67, triggered next day as low of day. More retrace?
|AGRX||up to $35M loan from Perceptive Advisors. $5 now, $15 upon appoval, $15 revenue milestones. ||2020-02-10|
|ABUS||AB-452 discontinued. Market response not too surprised. Open gap down then pull up. AB-836 IND by 2020.||2020-02-10|
Tonmya failed another Ph3 for PTSD. MCap $4.54m. -62% while issuing shares and warrants $7.5m.
Next focus is TNX-102 SL for Fibromyalgia, similar MOA with Tonmya, actually same drug.
|ZGNX||Fintepla (ZX008) for Lennox-Gastaut Syndrome (LGS) Ph3 results inferior to $GWPH (+7%) approved drug Epidiolex. -39%||2020-02-08|
|ASRT||$COLL Collegium Pharmaceutical acquire its Nucynta (Opioid Pain med) for $375m cash. Opioid crisis lost 95% value||2020-02-08|
|MRNA||Moderna expect Ph1 trial for coronavirus mRNA vaccine by the end of April. Similar to $TKMR in 2014 Ebola outbreak. +17%||2020-02-08|
|INSM||INS1007 (DPP1 Inhibitor licensed from $AZN) administered once daily for non-cystic fibrosis bronchiectasis (NCFBE), met primary endpoint. Analysts expected complete bust. Now OK results. currently nothing approved for NCFBE.||2020-02-08|
$ABUS Onpattro earnings
|Biotech||IBB/XBI/XLV:XLK reached unprecedented low level; healthcare biotech is ignored by investors||2020-02-05|
|CYCN||breakout cup-with-handle without news||2020-02-05|
|MRK||spin off Women's Health, trusted legacy brand and biosimilar business to focus on core strength. Keytruda to become best selling drug||2020-02-05|
|BIIB||Won patent challenge by Mylan on MS drug Tecfidera; preparing Alzheimer drug launch. up 29% mid-day announcement, close up 17.5%||2020-02-05|
|ABUS||upgraded by JMP analyst with $10 target. Up 15.3%. I am not that excited. Disappoints may follow||2020-02-05|
|DVAX||add $1.7k @4.99 200MA||2020-02-04|
#Biotech making round bottom turn around after 5 years of consolidationUpdate: 2020.2.22 3 weeks above 200 week line, long term trend reversed
|ABUS||Updated PPT: |
AB-836 new capsid inhibitor better potency than AB-506.
AB-452 decision in 1Q2020
AB-729 single dose data in late 1Q2020, multidose 1H2020
Cash $90.8M runway to mid 2021. include $18.9M ATM proceeds in Y2019
Principia Biopharma Mcap ~$2B get short report by Kerrisdale Capital noted misleading data and that its drugs do not work and that the data from its Phase 2 trials in the autoimmune diseases pemphigus and immune thrombocytopenia ("ITP") indicate likely failure in Phase 3.
next grave site for BTK in autoimmune conditions. Never worked.
|SNDX||raise $35m at 20% premium. up 41%||2020-02-01|
|XLRN||Ph2 success sotatercept for pulmonary arterial hypertension (PAH). up 74%|
Sotatercept is a ligand trap with high selectivity for multiple proteins within the TGF-beta superfamily, including activins, GDFs, and others. With its believed ability to block the TGF-beta superfamily signaling pathway, sotatercept could promote a rebalancing of BMPR2 signaling and, potentially, restore vascular homeostasis.
|AIMT||FDA approved Palforzia, the first for peanut allergy now 36, was $10. Just Peanut powder||2020-02-01|
|MGEN||anti-miR155 Cobomarsen positive data in adult T-cell leukemia/lymphoma (ATLL) MST 26months vs 7.4months||2020-01-31|
|EYPT||revenue for 4Q19 $6.9-7.6m up from $1m in 3Q. Up 14%||2020-01-30|
|BXRX||Baudax Bio $REPH Acute Care business segment spin out. FDA set 2.20.2020 for IV meloxicam for pain. Very close, never heard of. Up 13% in speculation optimistic.||2020-01-30|
|EPZM||EZH2 inhibitor tazemetostat accelerated approval for metastatic or locally advanced epithelioid sarcoma (ES). Sell on news -16%||2020-01-30|
|HZNP||FDA approved teprotumumab (anti-IGF-1R) for active thyroid eye disease (TED). 1month+ ahead of assigned PDUFA 3/8/2020||2020-01-30|
|NVAX||Novavax an influenza vaccine company, $VCNX cancer/autoimmune vaccine (not influenza vaccine) company both up 30% on speculation of coronavirus in China. ||2020-01-30|
|ASMB||look at HBV companies after chat with friend. pgRNA != RNA? cccDNA decline meaningful? Monotherapy potential? PPT|
$ARWR ARO-HBV+NUC results presentation
|SBPH||Discontinues inarigivir soproxil and entire HBV program after Ph2 liver toxicity and 1 patient death. To focus on STING. Was $18. Now $1.3. Loss 90%+. Dr. Sabb liked it.||2020-01-29|
ELX-02, is a eukaryotic ribosomal selective glycoside (ERSG) designed to increase the read-through activity in patients with nonsense mutations and enable the production of sufficient amounts of full-length functional protein to restore activity.
mixed data from Ph2 for nonsense mutation-mediated nephropathic cystinosis
ELZONRIS (anti-IL3R CD123) was approved by FDA on December 21, 2018, for adult and pediatric patients, 2 years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN)
declining revenue poor performance $13.1M->$11.8M
Ovaprene is a hormone-free, intravaginal ring designed to provide contraception over multiple weeks by releasing a locally acting agent which impedes sperm motility, coupled with a unique knitted polymer barrier that physically blocks sperm from entering the cervical canal.
undisclosed upfront and $20 million if Bayer decides to exercise its option, plus milestones that add up to $310 million
|AQST||FDA denied the company’s Citizen's Petition requesting the FDA stay (postpone) approval of a New Drug Application (NDA) for Valtoco (diazepam nasal spray) submitted by Neurelis, Inc for epilepsy cluster seizures. The FDA noted it had approved Neurelis's NDA on January 10, 2020.||2020-01-19|
|ACST||$AMRN competitor drug $ACST Acasti CaPre (highly purified omega-3 phospholipid concentrate derived from krill oil) failed Ph3||2020-01-19|
|BNTX||buyout $NTGN neoantigen was a below cash candidate||2020-01-19|
|DRRX||AdCom 6-6 for Posimir||2020-01-19|
|NKTR||FDA AdCom voted 27-0 against oxycodegol for chronic low back pain||2020-01-19|
|MNTA||M254 Hypersialylated IgG 5/6 response in idiopathic thrombocytopenic purpura (ITP) up 60% already 3.5B||2020-01-19|
NantKwest reveals "moonshot" one CR with PD-L1.t-haNK — NK cells engineered to express PD-L1 CAR — and N-803, an IL-15 fusion protein developed by ImmunityBio. 1 year base at $1, now 7X
|ADAP||T-cell Receptors (TCRs), chimeric antigen receptors (CARs) and utilize Astellas’ universal donor cell and gene editing platform deal to $897.5M $ADAP +240% poor performance and big market cap||2020-01-19|
|ACRX||Exceeded 2019 goals, yet no revenue. DOD meeting 2Q20. Set 2020 goals.||2020-01-13|
|APLS||Apellis pegcetacoplan (APL-2) for paroxysmal nocturnal hemoglobinuria (PNH) Ph3 success superiority to eculizumab (Soliris) $ALXN analyst worry that the market is hard to switch. Will be bought by $ALXN||2020-01-11|
|APLT||$10 IPO in May 2019 now $40 AT-001 Aldose Reductase inhibitor for Diabetic Cardiomyopathy. AT-007 CNS-penetrant inhibitor of Aldose Reductase for Galactosemia. AT-007 Ph2 success statistically significant reduction in plasma galactitol vs placebo.||2020-01-11|
|AGTC||up 88% to $7.84 positive interim six-month data from its ongoing Phase 1/2 trial in X-linked retinitis pigmentosa (XLRP).||2020-01-11|
|BPMC||FDA approved Ayvakit (avapritinib) unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.||2020-01-11|
|RARE||DTX-301 AAV gene therapy for ornithine transcarbamylase (OTC) deficiency success. 6/9 response Ph1. +23% #Genevant competitor||2020-01-11|
|PTLA||Andexxa poor sales $28mil, –40%. is the first and only specific reversal agent for apixaban- or rivaroxaban-treated patients with life-threatening or uncontrolled bleeding. Fought hard for its approval.||2020-01-11|
|NKTR||revise $BMY agreement to include 2 more trials for its bempegaldesleukin (bempeg) peg-IL-2.||2020-01-11|
|CHMA||NDA submitted. PDUFA expected mid-2020. Commercial launch 4Q2020. MPOWERED Phase 3 results on track 4Q2020 高开低走||2020-01-10|
|HJLI||CoreoGraft CABG Coronary Artery Bypass Grafting super success in animal feasibility study. Spike 50%. Fully open and functional at 6m, no complication, endothelial lined||2020-01-08|
2019.12.18 add 56 @$2.21 with lending rebate money
2020.01.06 add 117 @$2 to bring shares to 10000
|INCY||itacitinib (JAK1 inhibitor) in combination with corticosteroids for treatment-naïve acute graft-versus-host disease (GVHD) Ph3 failure||2020-01-04|
DUR-928 failed plaque psoriasis, other indication alcoholic hepatitis and an oral form in Phase I for nonalcoholic steatohepatitis. Success reported in 11.2019. Posimir post operative pain med pending approval with delayed PDUFA and AdCom.
long-acting injectable HIV candidate deal with Gilead
SB-206 NO tech failed Molluscum contagiosum, 30% vs 20% placebo, 3 years after Acne failure. Statistics claims "significance" hope. Short on cash 22.5m 3Q19. Competitor $VRCA 0.7% cantharidin achieved 46-54% complete clearance v 20% at the same week 12 endpoint
|SVRA||Molgradex, inhaled formulation of recombinant human GM-CSF, for autoimmune pulmonary alveolar proteinosis (aPAP), gets breakthough status from the same failure data on the basis of "totality".||2020-01-04|
|WVE||WVE-120102 antisense oligo targeting mutant huntingtin (mHTT) only 12.4% reduction much lower than Ionis-HTTrx (RG6042) 20-42% reduction. For Huntington's disease||2020-01-04|
|ABUS||$MRNA IPR challenge decision was published on PTAB bulk data. '435 partially (half) valid. '127 completely invalid. Follow link for a Markman Advisors comment||2020-01-03|
|AGRX||New website looking good.|
strengthen leadership with commercial hiring Kimberly Whelan (at $JNJ since 1987) for Vice President of Market Access, Charles S. Grass, CMA, for Senior Director, Finance and Matthew Riley for Product Manager.
|SLGL||Twyneo®, an investigational, combination of microencapsulated tretinoin 0.1% and microencapsulated benzoyl peroxide 3% cream, which demonstrated statistically significant improvement on all co-primary endpoints in the treatment of patients with acne vulgaris|
on my watch list with nice chart
|ACRX||Mark Edwards and Vincent Angotti 33k share buy #insider @$1.79 on 11.11-12.2019||2019-12-31|
|SELB||license to Asklepios Bio to develop and commercialize Selecta’s immune tolerance platform, ImmTOR, for use in adeno-associated virus (AAV) gene therapy for the treatment of Pompe disease. It inhibits immune response to AAV vector. My opinion: will be disasterous.||2019-12-23|
|CBIO||deal with $BIIB Biogen for $15 upfront Pegylated CB-2782 for Dry Age-Related Macular Degeneration. Pegylated CB-2782 is a protease derived from human membrane type serine protease 1 (MTSP-1) that cleaves complement factor 3 (C3).||2019-12-23|
|EPZM||EZH2 inhibitor tazemetostat AdCom 11-0 for metastatic or locally advanced epithelioid sarcoma (ES)||2019-12-23|
|NERV||MIN-117, antidepressant drug candidate, has a differentiated mechanism of action targeting adrenergic alpha 1a, alpha 1b, 5-HT1A, 5-HT2A receptors, serotonin and the dopamine transporter, fails MDD -16%||2019-12-23|
|PTI||disappointing data from Phase 2 trial in F508del homozygous and heterozygous cystic fibrosis, company claim positive, launching two Ph3||2019-12-23|
|ADMS||ADS-5102 high dose slow release Amantadine (nicotinic antagonist and noncompetitive NMDA antagonist) for MS will not initiate Ph3 due to 1st Ph3 failed at lower dose.||2019-12-23|
|GOSS||$NVS DP2 antagonist, fevipiprant (QAW039), fails Ph3 in asthma. $GOSS also DP2 antagonist, GB-001, -37% week||2019-12-23|
|MIRM|| maralixibat inhibits the apical sodium dependent bile acid transporter, for pruritus associated with Alagille syndrome. After FDA meeting, to file a rolling NDA in 3Q 2020. week up 188% to $23.57||2019-12-22|
discontinue suvodirsen (a stereopure oligonucleotide) exon 51 skipping for DMD
|AXSM||up 115% AXS-05 met Ph3 success major depressive disorder (MDD) 50X in 1y||2019-12-22|
|BigPic||$SSEC 头肩底 牛市要来了||2019-12-19|
|CHMA||added to Nasdaq Biotech Index $IBB||2019-12-19|
|DVAX||Ryan Spencer as new CEO and Novak as new president||2019-12-16|
|XBIT||bermekimab (anti-IL1a) True Human antibody screened from human blood donations. Also economic manufacture capacity. 2015 IPO at $19. Low $2.13. Now $20||2019-12-15|
|FATE||NK cell therapy leader. IPO in 2013 at $6. down to $1.5 in 2016, 3y 15X to $22.78 2019. ASH release positive data.||2019-12-15|
|FTSV||2018.06 IPO $16. down to $5.53. Now ~$40 with ASH CD47 success in high risk MDS, new pipeline anti-CD47+anti-cKit for HSC transplant. offering 4.86mil at $35 to raise $170M||2019-12-15|
|ARQL||buyout by Merck $MRK for $20/shr $2.7B. 9X in 1 year, 20x in 2 years after triple bottom $1. did not know this company before 2019.03 anyway.||2019-12-15|
|THOR||1 year after IPO, buyout by Sanofi for $2.5B $68/shr vs $15 IPO, 6X in 2 months. no set back.||2019-12-15|
|CORV||adcom voted 11-2 against approval. Old drug approved in Europe Canada etc. Rejected in 2008->Ph3 had hold due to patient death->now CRL again. Despite other products including 2 antibiotics, company now seeking to sell itself.||2019-12-15|
|ASRT||privately-held Alvogen will purchase its Gralise (gabapentin) for pain after shingles $75M cash||2019-12-15|
|SRPT||Vyondys 53 (golodirsen) for exon 53 skipping approved 4 months after initial CRL. 0.1% to 1% expression. Postmarketing Confirmatory results needed.||2019-12-15|
|AMRN||approved Vascepa (pure EPA) for reducing CV events. 2 weeks ahead of PDUFA||2019-12-15|
Quen: access model may be interesting. Hurdles: small volume. last resort, no clinical data on target population; No incentive to make it safer
|CORV||bad website showing stock stuff. Brinavess (vernakalant) for the rapid conversion of recent onset atrial fibrillation (AFib) to sinus rhythm (SR). FDA briefing doc for AdCom did not believe benefit outweighs risk.||2019-12-07|
|CARA||Korsuva met Ph2 primary for pruritus in CKD but missed key 2nd endpts. -35%||2019-12-07|
|SAGE||SAGE-217 miss 17-item Hamilton Rating Scale for Depression (HAM-D) for MDD. PPD success in 2019.01. 58% haircut||2019-12-07|
|AXSM||Ph2 success AXS-12 (reboxetine) for narcolepsy. 20X in one year||2019-12-07|
|ALLK||rumor for sale. 3X in a few months since IPO||2019-12-07|
|AUPH||Voclosporin, potentially best-in-class CNI (calcineurin inhibitor), could become 1st drug for Lupus Nephritis. Met Ph3 success||2019-12-07|
capped 4.5% royalty right of KSI-301 to Baker Bros. Advisors (BBA) for $225m and then followed up with a public offering of $317.4m.
KSI-301 Antibody Biopolymer Conjugate (ABC) of anti-VEGF to replace Eylea by extend ocular bioavailability and half life. Website front page highlight its IPO in 2018.12.10X in half a year.
|DVAX||Partnership with Albertsons Companies’ Pharmacies to Offer HEPLISAV-B® Hepatitis B Vaccine to Patients Nationwide||2019-12-05|
|AGRX||Perceptive Advisors bought 5.8mil shares $1.68 back after FDA delayed PDUFA. Previous sold 4.6mil @$0.44-0.51||2019-12-05|
|AQST||FDA approved Exservan (riluzole) Oral Film for amyotrophic lateral sclerosis (ALS)||2019-12-04|
|LJPC||to discontinue LJ401-BT01 for iron overload in beta thalassemia (BT), due to lack of efficacy||2019-12-04|
|ADMP||CMC CRL for Zimhi high-dose naloxone injection for opioid overdose||2019-12-04|
|CBAY||discontinuing seladelpar due to interface hepatitis in non-alcoholic steatohepatitis (NASH). -76%||2019-12-04|
|GBT||FDA granted accelerated approval for Oxbryta (voxelotor) tablets for sickle cell disease (SCD)||2019-12-04|
|CCXI||avacopan (CCX168) oral inhibitor for complement C5a receptor C5aR Ph3 success for ANCA vasculitis up 275%||2019-12-04|
|ABUS||$GSK $IONS GalNAc ASO horrible efficacy and safety, cannot compete with RNAi||2019-12-03|
|DVAX||Ph4 Similar rates of acute myocardial infarction between the two treatment arms at the interim analysis||2019-12-03|
|BOLD||Astellas acquire AAV gene therapy company for DMD Audentes, more deals to come||2019-12-03|
|MDCO||$NVS 9.7B buyout, mainly for inclisiran, formerly also owns IONSYS. 4x in one year||2019-11-25|
|CORT||-22% on USPTO IPR review challenged by TEVA||2019-11-24|
P-gp pump inhibitor, encequidar (formerly known as HM30181A), in combination with widely-used cytotoxic agents, enables oral administration of currently injectable-only drugs.
Up on abstract announcement
|MYOV||relugolix, Relumina, is a gonadotropin-releasing hormone antagonist (GnRH antagonist) medication which is used in the treatment of uterine fibroids in Japan. Meet Ph3 in advanced prostate cancer||2019-11-24|
|MDCO||Inclisiran trials showing LDL reduction further.||2019-11-24|
KarXT combines xanomeline, a muscarinic receptor agonist that preferentially stimulates M1 and M4 muscarinic receptors, and trospium, an approved muscarinic receptor antagonist that does not measurably cross the blood-brain barrier, confining its effects to peripheral tissues. So only CNS no peripheral side effects
Meet Ph2. Up 381%. 2019.06 IPO
|ALNY||GIVLAARI (givosiran) approved by FDA for acute hepatic porphyria, a rare, genetic metabolic disorder.||2019-11-20|
|DRNA||Another deal with $NVO on rest of liver: a potential list of 40 genes in the cardiometabolic disease. $175M cash + $50M equity||2019-11-19|
|CRSP||$VRTX first in human data promising: CTX-001 in sickle cell disease and beta-thalassemia. $CRSP is leader $EDIT $NTLA||2019-11-19|
|RUBY||RTX-134 Ph1b phenylketonuria data release delayed 1 quarter.||2019-11-16|
|KDMN||ROCK inhibitor KD025 works on cGVHD. Ibrutinib ($ABBV/Pharmacyclics) approved and Jakafi ($INCY) trying. $KDMN CEO former insider criminal||2019-11-16|
|SLDB||another SAE and clinical hold on its DMD AAV gene therapy. Still way above cash. Was $50 2018, now $3.5, will go lower||2019-11-16|
|LPCN||Tlando oral Testosterone Replacement Therapy received CRL. Was $18 in 2015. Now $0.39. Efficacy not convincing||2019-11-16|
|ASLN||Pan-HER inhibitor varlitinib failed biliary tract cancer. $10 post IPO. Now $0.45. $8mil cash. Pipeline random||2019-11-16|
|NXTC||no further response since abstract. Market disappointed. -57%. CR response in lowest dose 8mg, compared to recommended 400mg dose. Maybe PD-1 effect from prior treatment.||2019-11-16|
|VTGN||AV-101 failed Ph2 major depressive disorder (MDD). Similar to ketamine. See previous note. Has other pipeline neurology. Only 4 mil cash. Was $16 in 2015, now $0.30||2019-11-16|
|TORC||TORC1 inhibitor RTB-101 Ph3 failed in preventing clinically symptomatic respiratory illness (CSRI) in adults age 65 and older. Novartis spin out. Now below cash. Hope on Parkinson's due mid-2020.||2019-11-16|
|AMRN||Vascepa pure EPA omega-3 indication and label expansion AdCom voted 16-0||2019-11-16|
|NVS||$665M deal 3 year ago now approved. crizanlizumab anti-P-selectin for Sickle cell disease. Peak sales $250M||2019-11-16|
|ACRX||breaks down descending triangle. weekly RSI touches 30 for the first time.||2019-11-15|
PDUFA extented 3 months; AdCom too close to PDUFA; not surprising. -30% AH. touch 200MA/500MA. Fill gap?
PDUFA extension history: Xeris, Karyopharm, Sage, Regeneron, $DVAX all approved right before new PDUFA.
XERS: selling off till annoucement, rise after extension announcement.
KPTI: rise after announcement
SAGE: not significant price driver
DVAX: drop then rise (to top)
REGN: not significant price driver
Update: $1.36 gap closed second day after PDUFA delay.
Update 2: down gap closed in 8 days.
|BGNE||BTK inhibitor Brukinsa 泽布替尼 approved by FDA||2019-11-14|
|ABUS||AASLD posters 1 AB-506 tox in asian cohort 2 new capsid inhibitors||2019-11-12|
$ACRT regained rights from Curevac (leadership change) in 2019.02 to go alone. preclinical show 10% level in mice.
$TBIO Translate Bio is developing MRT5201 for the same indication. IND by year end. Using lipid nanoparticle LNP
Koss has lost its innovation. Outdated Bluetooth line, no TWS. China as the manufacture country has innovation edge on electronics. Sennheiser is doing well
|BIIB||Lemon Liming Wang defends GV-971 as Alzheimer's is in really bad need. Real world evidence trial? He also predicts Aducanumab will be approved.||2019-11-09|
ATM contract with H.C.Wainwright to sell $20M shares. When will they actually sell? -10% AH on Friday. $1.36 gap.Update 2019.11.11 No change
|TRPX||weed cannabinoid company. Proposed merger with Density Bio nixed||2019-11-09|
|SUPN||Ph3 SPN-810 fail in ADHD. From $6 to $60, now down to $20||2019-11-09|
|ALNA||reloxaliase ALLN-177 a crystalline formulation of the enzyme oxalate decarboxylase, specifically degrade oxalate within the GI tract, thus limiting systemic absorption of oxalate into the bloodstream. Did not work.||2019-11-09|
Ph3 nolasiban in women undergoing embryo transfer (ET) did not show higher pregnancy rate. (OBE001), an oral oxytocin receptor antagonist. -62%. Linzagolix (OBE2109) Oral GnRH receptor antagonist. Obstetrics focused.
|FGEN||so many expertise. roxadustat, for anemia in chronic kidney disease (CKD), global Ph3 release. slightly better than Epo||2019-11-09|
|ANAB||etokimab (anti-IL33) Phase 2b ATLAS trial moderate-to-severe atopic dermatitis failed. lost 90% value since 2018. $DERM anti-IL13 rally 18%. Strong pipeline||2019-11-09|
|NXTC||2019.5 IPO. Immunotherapy. NC-318 (Siglec-15 inhibitor) monotherapy Ph1/2 1CR 1PR out of 7 in NSCLC up 200%. NC-410 LAIR-1 fusion protein||2019-11-09|
|CNST||EZH2 inhibitor and BET inhibitor for cancer. CPI-0610 (BET inihibtor) Ph2 success in myelofibrosis. Up 119%. 2018.7 IPO||2019-11-09|
DOD milestone C meeting takes average 13 months to complete. Dsuvia purchase coming soon? Be Patient
$SAGE also has REMS: REMS certification is one step in the process for sites of care to be treatment ready. Given the need to achieve formulary approval, establish protocols for administering ZULRESSO and secure satisfactory reimbursement, full activation of sites can take an estimated 6 to 9 months or more.
|ABUS||retail investor on IV board dumped at "huge loss" and ranted angry languages at company and management||2019-11-08|
|DVAX||Investigator sponsored trials are still going. OX-40 in solid tumors; Prostate; Pancreatic; I-SPY2 breast cancer||2019-11-07|
|Checkmate||SITC show 25% ORR in refractory PD1 patients; preliminary neo-adjuvant data in melanoma; Monotherapy responses to CMP-001 $DVAX||2019-11-07|
|CHNA||Loncar China Biotech ETF||2019-11-07|
|China||$AZN setup venture fund after $LLY and Merck KG&A||2019-11-06|
MicroCap Biotech Below Cash 11.03.2019
KZR $3.09 59 KZR-616 immunoproteosome inhibitor for lupus, too much stock stuff on websiteNLNK $1.55 58 IDO inhibitors, lost 97% value
NTGN $1.92 54 personal neo-antigen
TRVI $3.51 63 neurology, nalbuphine ER, activator of kappa opioid receptor, inhibitor of mu opioid receptor, leading indication Prurigo Nodularis (PN), lots of bold languages
CYCN $2.11 58 guanylate cyclase (sGC) stimulators, Riociguat already approved, also has a sickle cell trial going 2019.04 spin off, some insider buy https://www.biospace.com/article/ironwood-pharma-announces-spin-off-of-cyclerion-therapeutics/
https://www.sciencedirect.com/science/article/pii/S1089860318300715AGTC $3.02 55 gene therapy for genetic blinding rare diseases
CBIO $5.74 69 coagulation Factors for hemophilia
ACRS $1.62 67 Immuno-inflammatory p38/MK2 inhibitor as oral alternative to TNF mabs; JAK inhibitors
SYBX $2.25 71 Synthetic biotic microbiome
OTIC $2.27 70 Neurotology, old drugs for hearing and balancing disease
ABUS $1.45 82 HBV
VSTM $1.10 82 PI3K and FAK inhibitor
ADRO $1.11 89 STING April
MRSN $1.98 95 XM-1536 ADC targeting NaPi2b, better than Genentech
FBIO $1.33 92 lots of programs lack focus
CMRX $1.54 95 polysaccharide heparinoids for AML, licensed from Cantex; smallpox
APTX $3.18 107 Neurology NMDA receptor modulator
IDYA $5.81 118 PKC inhibitor and synthetic lethality for oncology
ACOR $2.49 120 MS drug; ARCUS inhale tech; BTT1012 MOA unclear
JNCE $3.73 123 ICOS activating ab failed; PD1 ab
PRTK $4.06 132 antibiotic
FPRX $4.01 147 lost 93% since BMY data weak; Zai Lab deal; antibodies FGFR2b
CLVS $3.59 196 PARP, VEGFR PDGFR FGFR inhibitors (company webpage typo)
CTMX $6.10 277 Protease activated antibody and ADC
ADAP $0.92 578 TCR Pipeline Targeting Solid Tumors
|ACRX||130 REMS certified by October, 2months ahead of YE goal. 125 formulary goal on track. Expect to expand usage. Revenue increased from 0.055M to 0.116M. Zalviso continue on hold pending FDA policy change||2019-11-06|
|DVAX||10.2mil vs 8.3mil 2Q. Up guidance Y19 34-36mil. 3Q Loss 36.7mil. New website. Account market share 18%. Revenue market share 8%? Website redesigned.||2019-11-06|
3Q19: 1. AB-729 due 1Q2020
2. next Capsid inhibitor to select for IND in 2019.12
3. AB-452 go/no-go in early 2020
4. continue to develop oral PD-L1 inhibitor, delay cccDNA program
5. 90 mil cash to last till early 2021
|CPRX||not to be confused with $CBIO both are Catalyst||2019-11-05|
|ISEE||Rebranded $OPHT complement C5 inhibitor Ph2b success in dry age-related macular degeneration (AMD) +300% 1day||2019-11-03|
|CYCN||praliciguat (systemic sGC stimulator) boosts NO nitric oxide signal fails heart failure with preserved ejection fraction (HFpEF) and some effects in diabetic nephropathy. to refocus on Olinciguat (Vascular sGC Stimulator) for SCD||2019-11-03|
|MRTX||MRTX849 KRAS G12C reported Ph1/2 in solid tumors. up 23%. 3/6 NSCLC 1/4 Colorectal PR. First release, on par to AMGN||2019-11-03|
|CPRX||Amifampridine phosphate failed symptomatic treatment of Congenital Myasthenic Syndromes (CMS) Ph3||2019-11-02|
73 <=1; 163<=2 (554 biotech); price 185 <=$3
|ILMN||3Q19 earnings 6% sales growth. Analyst citing "sales of microarrays — tools used to read DNA — were soft. This implies 'that consumer genomics remains a sore spot'". What a joke! Evercore ISI analyst Vijay Kumar ||2019-10-31|
$AMGN invested $2.7B for 20.5% of Beigene to setup a China cancer alliance
Deal is very complicated. Rights, options, products, pipelines, limited years, equity, cost share, profit-loss share. Cong did lots of design, less negotiation. Shorts screwed. Short China, no fruit。 No need to be approved by US government. Not part of US-China trade war deal。小心过两年以后和他们打官司。Amgen的历史就是和合作伙伴打官司的历史。崔霁欣 “安进是以医药为主要关注方向的律师事务所”。
|Roivant||Vivek Ramaswamy trades top execs and adds stealthy vant to $3B sale, while his new partner tosses Myovant $350M||2019-10-31|
天境生物 赴美Nasdaq IPO 募资$100M pathway for the fast-track approval of drugs supported by solid overseas clinical data and granted priority reviews.
|DRNA||deal with Roche ($RHHBY) to develop DCR-HBVS for HBV $200M upfront and $1.47B milestones $ABUS up 75%||2019-10-31|
|AGRX||10K and S-1 SEC filings stated competition from Bayer's patch containing gestodene, 1.6X VTE risk v LNG. No gestodene approved in the US despite Wyeth and Bayer's attempt.|
Ortho Evra 2013 sales $153M, Xulane sales 2016 $211M, 2017 $233M 11% CAGR 3X opportunity for Twirla
|BigPic||Margin debt down again in September 2019. Fed cut rate and signal no more cut in the future||2019-10-30|
CMO Elizabeth Garner left company in 07.2019 to join ObsEva as CMO. still serving as consultant. Presented at AdCom
CFO Scott Coiante left company in 08.2019 to join Aprea Therapeutics. New CFO Dennis P. Reilly
|ACRX||6.48% heavy drop ahead of key earnings report. testing $2 resistence. Volume came after drop.||2019-10-30|
|AGRX||BRUDAC AdCom voted 14Y-1A-1N in favor of approval Twirla, Reverse FDA negative briefing. Buyout target $30-50 ($2.4-5.0B by 80-100M shares) up +350% next day||2019-10-30|
|ARWR||40x 70x in 2 years $ABUS||2019-10-29|
|GILD||revenue flat, R&D hurt profit||2019-10-29|
re-started manufacturing development at Corium, aim to complete commercial manufacturing process validation in 2H2020
Commercial plan: 1Q managed care and payer access 2Q 60-90 persons sales team 4Q commercial launch significant number of samples in the early stageBuyout in 2021? Was too optimistic when I init at $7 in 2016
|AMAG||2011 accelerated approval of Makena failed confirmatory trial. AdCom voted 9-7 to withdrawl now vs a new trial||2019-10-29|
|EYEN||reprioritization: advance MicoLine for Presbyopia into Ph3. Deter MicroTears (red eye and itch relief/lubrication) and MicroProst (glaucoma and ocular hypertension). Continue MicroPine (Myopia) and MicroStat (Mydriasis). save $1.5~1.9M in 2020||2019-10-29|
Added $1.5k 2000 shares at $0.75 as planned gap fill. Closed at $0.45 -60%
PR says FDA briefing doc (released shortly after PR) expresses a number of concerns regarding Twirla’s approvability, including, but not limited to, concerns related to Twirla’s efficacy when balanced against its safety. The FDA also did not appear to agree with the Company’s proposal to include a limitation of use based on patient weight and BMI in the product label.
Further down to $0.35 the next day.
I got my planned 2000 shares at a lower price ($0.75) than planned ($0.90). Did not know it will go further down. Didn't get the cheapest. No regret, only missed a few hundred dollar, not planning to buy more than 10000 shares anyway. $ACRX and $DVAX did not. This one is so negative, per previous review record with the FDA team and FDRR.
|ACRX||Add $2.1k 970 shares at $2.20 flat base||2019-10-28|
1. FDA approved triple Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for CF
2. NHS England deal for access its cystic fibrosis medicines
|ASRT||CRL for injectable formulation of long-acting cosyntropin for the screening of adrenocortical insufficiency.||2019-10-27|
|SGEN||all time new high on tucatinib (small molecule Her2 inhibitor) Her2+ advanced breast cancer news||2019-10-27|
|MGNX||margetuximab anti-HER2 Ph3 OS 21.6m vs 19.8m not significantly better. Market sell off||2019-10-27|
|ANIK||proprietary technology is based on hyaluronic acid (HA), a naturally occurring polymer found throughout the body vital for proper joint health and tissue function. 20x return from 2009. Products of many categories. $30M quarterly revenue, $1B market cap. Revenue and EPS surprise||2019-10-27|
|BigPic||Yale professor Robert Shiller predict stock bubble is now.||2019-10-27|
|RAPT||Formerly FLX Bio return to IPO with CCR4 small molecule inhibitors, after Kyowa Hakko unveiled positive Phase III data for the anti-CCR4 therapy mogamulizumab.||2019-10-23|
|ALKS||lost -80% since 2015. Cut R&D cost and slash 160 jobs. save $150mil. Seems lots of restructuring in biotech||2019-10-23|
|TDG||TransDigm used to be IBD50 stock, aerospace leader, up 10X since 2010.||2019-10-22|
|BIIB||Alzheimer’s drug aducanumab may have subset effect, FDA suggests filing. Up 40%. IBB +3%. People not convinced.||2019-10-22|
Dirk's open letter to urge BOD to focus on RNAi AB-729 and sell the company for $5. Dirk called it a retirement plan for old pharma execs [paraphrase]
Relmada Ph2 REL-1017 (dextromethadone, an N-methyl-D-aspartate (NMDA) receptor antagonist), as an adjunctive treatment for resistant depression. success. up 76% to $19.81.OTCBB IPO Jun 25 2014, uplisting to NASDAQ 10.10.2019 Flat for 3 years on OTCBB 1:4 reverse split
up 73% to $15.05. Mizuho Securities initiated coverage $20 target. CEO is $GILD CSO John McHutchison
|SYRS||SY-1365, its intravenous (IV) CDK7 inhibitor to be discontinued. To focus on SY-5609 (Oral CDK7 inhibitor)||2019-10-19|
|ACHN||buyout by $ALXN complement pathway pipeline, including a danicopan (ACH-4471) — a complementary therapy for PNH patients taking Alexion’s Soliris (FDA gave break through therapy after Ph2 results). Was $16 in 2015. Now sold for $6.30||2019-10-19|
|RETA||omaveloxolone Keap1/Nrf2 activator met Ph2 Friedreich’s ataxia (FA). Precise MOA related to Mitochondria, Oxidative stress, and inflammation. |
“(T)he Street had been broadly negative on OMAV’s potential in Friedreich’s ataxia (FA) – as earlier P2 results were viewed as mixed, and FA is well-known to investors as a notoriously difficult indication to crack,” Stifel’s Adam Walsh wrote in a note.
Put more efforst on these precise MOA and rare genetic disorders. #positive surprise
|DVAX||OX40+SD101 trial suspended||2019-10-18|
|Y--95%||$VIVE weird women health collagen generation device|
$SNNA bankruptcy after SNA-120 (TrkA inhibitor with polymer) fails
$JAGX see previous
$MTFB see log, Iclaprim ABSSSI FDA demand additional trial
$ADXS see log, axalimogene filolisbac attenuated Listeria Immuno-oncology FDA hold + CMC
$XBIO Scripps XCART company, but lead drug is immuno-modulator IFN/TLR9. MCap $5M
$TOCA see log, MOA too complicated
|Y+300%||So few gains:|
$AXSM see previous.
$RCEL australian company RECELL Spray-on Skin Cells regeneration system. just transferred from OTCBB to Nasdaq
|Biotech||House push bill unlikely to pass. At least 50% NMEs come from small biotechs. Given potential devastating impact of H.R. 3 on capital markets, ONLY 8-15 fewer NMEs approved is FAR too low. ||2019-10-15|
|AKCA||license agreement with Pfizer (NYSE:PFE) for AKCEA-ANGPTL3-LRx (antisense to angiopoietin-like 3 in liver a key regulator of triglycerides, cholesterol, glucose, and energy metabolism), for certain cardiovascular and metabolic diseases. Akcea, and Ionis, each receive $125m upfront, and milestone payments of up to $1.3b.||2019-10-12|
FDA approved PF708 (Teriparatide equivalent) for tosteoporosis. Pfenex has engineered Pseudomonas fluorescens expression technology "Rapid, high-quality, high-yield production and analysis of difficult-to-produce proteins"
2014 IPO $6, from ~$24 in 07.2015 to $2.3 in 12.2017, now $9. Mcap $280M
|CLVLY||Australian company Clinuvel received FDA approval for Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria. up 37% to $24.80. OTCBB||2019-10-12|
|ONCS||received $30M from China Grand Pharma (CGP远大健康) at $2.50/share, 53% interests, option to buy the rest. Exclusive License to TAVO™ (IL-12) in Greater China and 35 Other Asian Countries. CGP Obtains a 12-Month Option to Offer to Acquire the Remaining Shares of OncoSec at the Greater of $4.50 Per Share or 110% of the Market Price.||2019-10-12|
IPOed in 2016 at $11, slightly up till 03.2018. Rise to $92 in 09.2018
Regain right to bardoxolone methyl, activator of Nrf2, inhibitor of NfkB, for $330M from $ABBV, who invested $850M around 2010. $ABBV later left renal-cardiovascular field and understood patient need. Ph3 readout coming. up 19%
bought Rhofade (Oxymetazoline HCl) from Allergan for $65M in 12.2018, previously acquired the rights in 2011 when it bought Malvern-based Vicept Therapeutics. Vicept was led by several members of the current senior management team at Aclaris including Walker, who was Vicept's co-founder, president and CEO.
Divested to EPI Health for $35M+$20M sales milestones to focus on immuno-inflammatory assets
|VIR||IPO at the lower range. Pipeline not so impressive. Only HBV candidates VIR-2218 ALN-HBV02 RNAi VIR-3434 entry blocking antibody. And flu vaccine. ALNY deal only $10M upfront. ||2019-10-11|
|Biotech||Deal number similar to 2018 deal size smaller. China money huge decline.||2019-10-11|
|BigPic||Phase I deal reached between US and China up +1% in larger volume. Previous worry disarmed.||2019-10-11|
|Softbank||Uber WeWork投资持续亏损 调整策略 加强盈利模式 和 IPO路径考量||2019-10-11|
|BNTX||BioNTech IPO $3.4B Genmab $GMAB $11.5B VIR Biotechnology $VIR $2.4B BridgeBIO Pharma $BBIO||2019-10-10|
|RARX||take over $2.1B by UCB 8X since low, 3.5X IPO Complement C5/C5b inhibitor; as Alexion C5 inhibitor competitor||2019-10-10|
|NKTR||removed from SP500 as the worst performance on 10/2/2019 After Market||2019-10-09|
|ALLY||follow Schwab TD E*Trade IB TS $0 commission. Vanguard Fidelity still remains||2019-10-08|
|DVAX||CSO Robert Coffman to retire, no plan for replacement||2019-10-07|
ATM sold 143K shares at ~$1.43, raised $205K, hence offering.
I over estimated value peak sales $300M. $7 way too expensive in 2017
|SGEN||enfortumab vedotin combined with Keytruda triggered an impressive 71% overall response rate in frontline patients — 32 of 45 patients — who were ineligible for chemo. vs 29% ORR Keytruda alone||2019-10-06|
|GTHX||G1T48 is a potential best-in-class oral selective estrogen receptor degrader (SERD) for estrogen receptor-positive (ER+) breast cancer. clinical benefit rate (complete response + partial response + stable disease for at least 24 weeks) across all doses was 15.8%. down 33%||2019-10-06|
|NERV||Roluperidone is a 5-HT2A and σ₂ receptor antagonist to treat negative symptoms in schizophrenia. Ph3 recruitment delay due to cyber-attack at external contractor.||2019-10-06|
|SVRA||down 67% to $0.93 FDA advised not to submit a Biologics License Application (BLA) for Molgradex, for autoimmune pulmonary alveolar proteinosis (aPAP) due to insufficient evidence of efficacy and safety.||2019-10-06|
|DOVA||acquired by Swedish Orphan Biovitrum AB for $27.50 + $1.50 CVR close to IPO price||2019-10-06|
AB-506 capsid inhibitor two acute hepatitis in Ph1a 28-day healthy volunteers study, to discontinue
Poor track record? AB1467 AB1740 AB452 AB506 AB423
Always wait for data, especially for mysterious safety signal. AB506
Opinions: 1. capacity of small molecule drug design 2. cash low 3. AB-729 may also fail 4. LNP IP erosion 5. falling behind competitor 6. need outside capsid inhibitor cannot wait
Pessimistic. Very little value left.
|MRNS||up 23% open-label, dose-finding Ph2 trial IV ganaxolone in refractory status epilepticus (RSE), met the primary endpoint||2019-09-28|
|CNCE||Concert Pharm -37% on Avanir Pharm failed Ph3 AVP-786 for moderate-to-severe agitation in patients with Alzheimer’s dementia. AVP-786 like Nuedexta, is a combination of dextromethorphan and quinidine. But it also contains deuterium, an isotope of hydrogen.|
"exact mechanism of action by which AVP-786 reduces agitation in Alzheimer’s patients is not known. However, scientists think that its penetration into the brain leads to the activation and repression of certain neuronal pathways, which help to ease agitation."
|AKCA||down 20% on departures of Paula Soteropoulos, chief executive officer, Sarah Boyce, president, and Jeff Goldberg, chief operating officer.||2019-09-28|
|AZRX||2016 $5.5 IPO raised $5M. Yeast derived MS1819 lipase in Ph2 trial to replace porcine derived products for exocrine pancreatic insufficiency in cystic fibrosis (CF). 56% in MS1819 vs 81% in PERT. Not so "comparable" as company claimed. https://scr.zacks.com/News/Press-Releases/Press-Release-Details/2019/AZRX-OPTION-Trial-Readout-article/default.aspx||2019-09-28|
|MDCO||Inclisiran Ph3 ORION-9 in Heterozygous Familial Hypercholesterolemia (HeFH) and ORION-10 in atherosclerotic cardiovascular disease (ASCVD). Flat. Expected by market?||2019-09-28|
|ENTA||a viral and liver disease company. has EDP-514 HBV core inhibitor in Ph1. EDP-305 FXR agonist and Enanta’s lead product candidate just met primary endpts (p=0.049), 51% of high dose cohort has itching. 1B company -16%||2019-09-28|
2017 merger of older companies since 1990. Focus on sleep medicine and our suite of sterile injectable products. FT218, nightly Micropump®-based formulation of sodium oxybate, the only approved drug for excessive daytime sleepiness (EDS) and cataplexy in patients suffering from narcolepsy. #newformulation
2019.09.28 FDA lower enrollment required. half year time saved$25 in 2015 to $1 in 2019
|China||海航扩张过快 债务高企 艰难返航 不同的领导人不同性格||2019-09-28|
|MRNA||Immunotherapy Research Collaboration with Harvard HMS immunology community for mRNA and nanoparticle delivery tech. ARTiMIS Alliance for RNA Therapies for the Modulation of the Immune System||2019-09-26|
|China||pkubio.com PKU Biologics 北大生物 未名集团旗下 安徽巢湖 ATCG ANTIBODY十几幢字母形状大楼||2019-09-24|
Margin Debt down more than 6% in AugustTrump trick Biden and Demo into impeachment. China deal may come sooner than expected. Don't predict.
A-101 45% Topical Solution met Ph3 THWART-2 trial for common warts. up 38%. But already lost 95% value since 2017.Eskata not on website product page anymore.
|SNNA||LA company Sienna files bankruptcy after SNA-120 (TrkA inhibitor with polymer) fails and cash struggle. Once $24 now $0.18||2019-09-21|
|ZYNE||Ph2 data show safety concerns: 96% TEAE 60% TRAE 10/46 SAE||2019-09-21|
|ALDR||sold to Lundbeck for $18+$2CVR total $1.95B 2014 IPO price $10. Only 2x return in 5 years. Overpriced IPO. Peak $45 Low $9. Could not compete with Erenumab.||2019-09-21|
|Biotech||FDA lays out TMAP Technology Modernization Action Plan e.g. infrastructure that can accept, evaluate and analyze novel sources of data (e.g., real-world data) and apply that data to regulatory decision ...||2019-09-18|
Fed lowers interest, the second time. ; Biotech IPO trend normal
|Biotech||Twitter: 1) Boston traffic exit, CEO pulled up to VC for exciting NHP data. 2) Follow on dead. Low sentiments political||2019-09-17|
|RTTR||2.5 years after Ph2 failure. The company reported Ph3 failure. Done.||2019-09-14|
|ADVM||formerly Avalanche Biotechnologies (failure in 2015) merged with Annapurna Therapeutics to form Advertum Biotechnologies, Inc. |
Early 6 patient ADVM-022 wet AMD results failed again with wide variation. One patient may lost 10 letters
|TOCA||final results Ph3 Toca 5 trial confirm interim analysis lack of efficacy. TOCA 511 delivers cytosine deaminase (CD) gene, then TOCA FC been converted by CD to 5-FU, which kills tumor cells. Too complicated. 2017 IPO, raised $86M. Lost 90% value.||2019-09-14|
|FCSC||after 1:3 in 2017 1:5 in 2018, finally sold to Castle Creek for $3 per share. Lost 97% 2015 value. I was right.||2019-09-14|
|NTRP||Ph2 trial Bryostatin-1 miss endpts for Alzheimer's -80% to 0.88|
2013 reverse merger OTCBB
2017.01 reverse split 1:32 to uplist on Nasdaq before trial announcement in 2017.04
2017.03.29 a price run after announcement, began trading on Nasdaq
2017.05.01 touted "positive results" in a small trial. stock plunge.
Now lost 95% value, touted as the "natural compound from the deep ocean", "unique PKCe activating mechanism" that stimulate synapse growth, anti-amyloid, anti-tangle. Turns out it does nothing, failed just like every other Alzheimer drug
|LXRX||Sanofi pays termination fee of $260M. Up 70%. And Lost 90% value since 2016 peak.||2019-09-14|
|MNK||sell CDMO business to BioVectra for $250M, previously reported bankruptcy risk gone, up 76%||2019-09-14|
|AIMT||AdCom FDA briefing good, vote 7-2 efficacy 8-1 safety for AR101 peanut allergy PDUFA 01/2020 up 40% week||2019-09-14|
|ABUS||added $1k 568 share @$1.77 prior to pending patent decision. No decision came from USPTO. AB-506 then discontinued.||2019-09-12|
|MRNA||show off Ph1 results of mRNA-1647 (mix 5 mRNAs) CMV vaccine and mRNA-1944 antibody to against chikungunya infection||2019-09-12|
|Biotech||Golden age 1. technology advance 2. human biology understanding 3. new modality 0. NIH/HHMI||2019-09-11|
|ACAD||pimavanserin met Ph3 for dimentia||2019-09-09|
|Biotech||Janet Woodcock comment on drug pricing: “The science is fabulous, but that’s not enough.” “The goal isn’t just improving knowledge. The goal isn’t FDA approval. The goal is to improve human health.” Poor people should afford new medicine||2019-09-09|
|MDCO||ORION-11 Ph3 data release 54% LDL-C reduction at Day510, average 50% LDL-C reduction from Day 90 to 540||2019-09-07|
|EBS||awarded HHS contract $2B over 10 years for continued supply of ACAM2000, (Smallpox Vaccine, Live) into the U.S. Strategic National Stockpile (SNS)||2019-09-07|
2014 IPO rise to $20.90 in 2018 on no news, start dropping with no insider selling, general biotech bearish sentiments?
|ARDX||Tenapanor met all Ph3 goals. Designed to act only in Gut to inhibit NHE3, tighten epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate, the primary pathway of phosphate absorption.|
Tenapanor IBS-C PDUFA 9.12.2019
2014 IPO mediocre performance since. NO rise even with IBS-C NDA. mysterious rise around 8.16.2019 no news.
|Opioid||$EGLT bankruptcy 2018 used to be $250M MCap|
$PTIE pain therapeutics changed name to neurodegenerative focused Cassava $SAVA down 90% from 2014
$MNK $1.87/shr -98% from 2015 peak of $132/shr
$ENDO $3.48 / $94 lost 96% value
$DEPO changed name to Assertio focus on neurology, orphan and specialty medicines. -96%
$KMPH lost 96% Apadaz approved no abuse-deterrent label, licensed out, now focus on ADHD
$DRRX non-opioid injection Posimir approved, no price rise.
|MNK||Mallinckrodt Plc explore options seeking bankruptcy $1.87/shr -98% from 2015 peak of $132/shr||2019-09-07|
|GBT||FDA accepted voxelotor (increasing hemoglobin’s affinity for oxygen) NDA for SCD. No AdCom planned.||2019-09-07|
|Roivant||sell 10% AND 5 vants to Sumitomo Dainippon||2019-09-05|
|BigPic||Follow-through-day, GapIndex, $CPC all confirms a new uptrend on the way||2019-09-05|
|IDRA||Phase 1b collaboration with $ABBV OX40+TLR9+Chemo/PD1, $ABBV conduct study, $IDRA provide tilsotolimod||2019-09-05|
|Biotech||reputation sink to rock bottom after federal gov||2019-09-04|
|AERI||issuing $250M convertible debt w. $937M market cap||2019-09-03|
|ALXN||Rumor $AMGN will buy it out, news USPTO will review IPR challenge of Soliris from $AMGN||2019-09-02|
|PRTA||EcoR1 capital 23.6% ownership Schedule 13D, up 22%||2019-09-02|
artificial vein for deep vein insufficiency and CABG Coronary Artery Bypass Grafting. potential buyout candidate orange county
|MDCO||Inclisiran licensed from $ALNY PCSK9 siRNA met all Ph3 endpts. half year dosing, much better than Praluent / Repatha twice monthly or monthly doing, safety OK. siRNA is better than antibody||2019-08-27|
|ACRX||bearish SA article full of non-sense||2019-08-27|
|JNJ||$TEVA $ENDP $MNK $JNJ all jump on $572m fine for opioid crisis, much smaller than $17B claimed, will still appeal $ACRX||2019-08-27|
|ACRX||Mark Edwards 15,000 shares #insider buy $2.19||2019-08-26|
|AMGN||bought Otezla from $CELG. $BMY clears anti-trust path to buy $CELG||2019-08-26|
|SYBX||SYNB1020 did not lower blood ammonia in Phase 1b/2a interim analysis||2019-08-26|
|RTRX||fosmetpantotenate in pantothenate kinase-associated neurodegeneration (PKAN) did not meet its primary endpoint||2019-08-26|
|ENDP||$10m settlement with Cuyahoga and Summit counties for Opioid epidemic||2019-08-26|
|CLSD||CRL Xipere (triamcinolone acetonide suprachoroidal injectable suspension). FDA requested stability data for its new manufacturing process||2019-08-25|
|VNDA||CRL sNDA Hetlioz (tasimelteon) for Jet Lag Disorder (JLD): measures demonstrating improved sleep in its previous trials were unclear clinical significance||2019-08-25|
|SRPT||CRL golodirsen injection for Duchenne muscular dystrophy (DMD) in confirmed mutation amenable to exon 53 skipping due to infections related to intravenous infusion ports and renal toxicity seen in preclinical trials.||2019-08-25|
|TROV||new clinical data from its Phase 2 trial of onvansertib, first-in-class, 3rd generation, oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, in combination with anti-androgens (anti-testosterone) Zytiga (abiraterone acetate)/prednisone, in metastatic Castration-Resistant Prostate Cancer (mCRPC), will be presented at the Asia-Pacific Prostate Cancer Conference, on August 24 in Australia. up 47%||2019-08-18|
|RHHBY||FDA approved Rozlytrek (entrectinib) for the treatment of patients with any type of solid tumor that has a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. This is just the third time the FDA has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated. ||2019-08-18|
|ABBV||FDA approved Rinvoq (upadacitinib), a once-daily oral Janus kinase (JAK) inhibitor, for moderately to severely active rheumatoid arthritis (RA)||2019-08-18|
Ripretinib DCC-2618 dual KIT PDGFRa inhibitor success in 4th line patients, great PFS, 6.3m vs 1.0m, ORR 9.4% vs 0% not significant. week up 58%. raise $400M
$BPMC down 9% with same MOA drug Avapritnib in NDA stage
|SRPT||case submitted to FDA Adverse Event System, later says error, still down 14%||2019-08-12|
|CLVS||Competitors AstraZeneca and Merck announced positive data from a Phase 3 trial of Lynparza in men with metastatic castration-resistant prostate cancer (mCRPC). Clovis also announced an offering of $225m of convertible notes. ||2019-08-12|
|KALA||KPI-121 for dry eye disease CRLed. FDA requires 3rd Ph3 data coming in 4Q19. Previous 2 Ph3 data were mixed.||2019-08-12|
|AMRN||surprising AdCom scheduled 11.14.2019, no ADCom was expected, PDUFA extended 3 months. down 17%||2019-08-12|
|NKTR||down 29% to $20.92 on news that suboptimal batches of NKTR-214, in combination with Bristol-Myers’ Opdivo, were given to some patients in trials, which caused a softening of responses. |
reducing $BMY collab scope
FDA suspended new opioid app
|GKOS||iStent inject Eye pressure Glaucoma relief company bought Avedro $AVDR corneal health business, up 28%||2019-08-12|
|AMGN||won litigation against Sandoz on Enbrel patent. extend Enbrel to 2029||2019-08-12|
|MRNA||heavy selling since #ASCO19||2019-08-12|
a therapeutic antibody that targets Siglec-8, an inhibitory receptor found on the surface of mast cells and eosinophils. We are testing AK002 in a number of diseases where eosinophils and/or mast cells have been shown to play a role in the disease pathology.
met all primary and secondary endpoints in its Phase 2 trial of AK002 in patients with eosinophilic gastritis and/or eosinophilic gastroenteritis. up 174%, recent IPO straight success
|ACRS||discontinue Eskata commercialization efforts to focus on immunology assets. Blame Physicians Patients acceptance not drug||2019-08-08|
|IDRA||making progress on its TLR9 program||2019-08-08|
|RGLS||2Q19: private placement, debt restructure, office move, new CFO, and focus on RGLS4326 for ADPKD, perclinical NASH anti-miR132 to seek partner||2019-08-08|
|CLSD||to out license XIPERE, R&D expense only $0.7mil. Up 28% fron $1, penny zone||2019-08-08|
IV post: 1. priced above open market price $3 vs $2.99 close. 2. demand $70.1M more than proposed $60M 3. some buyer prefer not to be identified. A potential buyer?
Compare to my desperate emotion of bankruptcy?Me: SD-101 may be a dead asset, at least in the near term. Could not find any buyer, hence the raise.
|CHMA||expect NDA YE19, MPowered trial results 2H19, 58mil cash, 8m/Q burn||2019-08-08|
sales up, canada and japan approval, CEMEA progress, 2B cash, 1B/year cash burn, CFA change, strong pipeline, $400M upfront +$400M equity deal with Regeneron.Vutrisiran a risk factor for ONpattro and $ABUS
Vir.Bio licensed $ALNY ALN-HBV02 as VIR-2218 ESC+ GalNac RNAi. trial started 11.2018. $ABUS 8 months late. Single agent
Johnson & Johnson's Janssen unit paid $ARWR 25mil related to the start of dosing of a patient cohort in the phase 1/2 clinical study evaluating a triple-drug combo of JNJ-3989 (formerly ARO-HBV), JNJ-6379, and a nucleotide analog in Q2. $ABUS a year late triple combo
$BHC $ETON over-the-counter (OTC) preservative-free formulation eye drop for the treatment of ocular itching associated with allergic conjunctivitis
|PIRS||PRS-060 serves to treat moderate to severe asthma through direct delivery of a potent IL4Ra-targeting Anticalin protein to the lungs. Announced late-breaking presentation of Phase 1 multiple ascending dose trial ||2019-08-07|
|MYL||Mylan to Merge wit Pfizer's Upjohn.||2019-08-07|
8.3 million Q2 sales, 32-36mil FY19. No deal. public offering 60m. Bankruptcy / Reverse Split coming?
Ph4: The interim analysis in the study are not time based analyses, rather they are event driven. And thus, the timelines for data are based on projected rates of cardiac events, which have been consistent with original expectations.
Priced: 23.365mil shares at $3 for $70.1mil. 0.25 share warrant per share priced at $4.5, expire 02/2022. Not bad.
|GLYC||rivipansel (GMI-1070) for sickel cell disease miss endpoints||2019-08-07|
|ACRS||ATI-501 JAK1/JAK3 Inhibitor Oral also mediocre in Alopecia areata, Pfizer better. Topical failed in June.||2019-08-07|
|ACRX||2Q19 still no revenue, making progress. Zalviso on hold pending FDA policy change||2019-08-06|
new fear on trade war, sharp drop in big market. TA looks good.08-14-2019 Trump blinked, postpone the deal for Christmas Season
|Biotech||Arie Belldegrun and the crew at Vida reap a $600M harvest for fund II — and they've got LA in their sights||2019-08-02|
Q2 raised ATM cash $1.4m ~1m shares at $1.4; public offering announced when current cash till end of 2019. Priced $0.95 for $12MOver-Allotment fully exercised. Total net proceeds $12.6mil on 14.5mil shares. Bring shares to 59.1mil
|BigPic||Fed lower rate by 25 base points, and hint "midcycle adjustment", not a start of new trend||2019-07-31|
|AMGN||up 5.7% on increasing demand for its new drugs||2019-07-31|
|ABUS||$MRNA Moderna is trying really hard to challenge LNP patents. '069 patent IPR was instituted on 7.24.2019 IV post||2019-07-30|
|MRNS||Ganaxolone; GABAA neurology drug fails in women with postpartum depression (PPD) down 71%||2019-07-29|
|ACAD||miss Ph3 Enhance trial of pimavanserin as an adjunctive treatment in adult schizophrenia patients||2019-07-29|
|NTEC||Accordion Pill-Carbidopa/Levodopa (slow release) miss Ph3 in Parkinson's. Down to penny||2019-07-29|
|ACHN||2nd gen complement Factor D inhibitor ACH-5228 pass Ph1 MAD in HV, up 95% week||2019-07-29|
|LXRX||Sanofi $SNY terminated collaboration to develop Zynquista (sotagliflozin) in all diabetes following mixed Ph3 data. Lexicon considered it invalid and in breach of contract||2019-07-29|
|ITCI||adcom cancelled schizophrenia drug, lumateperone tosylate capsules||2019-07-24|
|IONS||$BIIB posted Q2 earnings, Spinraza (licensed from IONS) sales only 15% increase, disappoints||2019-07-23|
OPTIMAL trial met primary and secondary endpoints 2 months ahead of schedule. up 40%. 90% choose to stay, 58% vs 19% placebo maintained IGF-1 response.sell off on news, 2 days to below pre-news level. Proposed offering. $5.5 per share 10mil shares
|AMGN||first cancer biosimilars approved Mvasi (bevacizumab-awwb) and Kanjinti (trastuzumab-anns). Rituxan biosimilar also coming. Uptake will be slow.||2019-07-21|
|SGEN||Adcetris (Brentuximab vedotin, CD30 ADC) doing well. enfortumab vedotin (anti-Nectin-4 ADC) for urothelial cancer may gain approval.||2019-07-20|
|SCPH||FDA says no further clinical safety, efficacy, or pharmacology trials required. To resubmit NDA in mid 2020||2019-07-20|
|AVRO||06.2018 IPO. Lentiviral gene therapy. Success in early trials of Fabry disease.||2019-07-20|
|BHVN||disappoints due to manufacturer Apotex problem affect bioequivalence study||2019-07-20|
|GILD||$5B cash+equity deal with $GLPG galapagos. Why didn't I find this research powerhouse? then preclinical deals with $NVS||2019-07-20|
deal in 2017 popped stock to $220. Now cool off, BMY dismissed PD1 deal, $172M/Q cash burn, 1.6B cash ~9 quarters, need to raise cash in 2020, to fill gap at $55.
王婷：CMO keep changing, manufactured outsourced, will have supply problem, too many trials, PD1 approval keep delayed ...
|AGRX||Previous Chief Commercial Officer Renee Selman (07.2016-06.2018) left in 2018 during the cash saving lay off, now appointing new CFO with commercial experience Dennis P. Reilly from Invisible Sentinel, Inc., sold to BioMeriux, a French biotechnology company. All previous 3 small companies were sold.||2019-07-18|
|ABUS||Replicor shown 04.10.2019|
Transaminase flares are rare during natural course of infection or with approved therapies
- Safe and correlated with declining HBV DNA, HBeAg seroconversion, HBsAg loss and functional cure
During REP 2139/pegIFN therapy, flares are highly prevalent (96% of participants)
- Not correlated with baseline HBV DNA, HBsAg, ALT or median hepatic stiffness
- Occur in HBeAg negative, HBeAg positive and HBV / HDV co-infection
In 98% of these cases (49/50) liver function remains unaltered
- Flares are otherwise asymptomatic in patients with mild to advanced fibrosis
HBsAg clearance during flares may define their prognostic value:
< 3 log10from baseline (typically > 10 IU/mL): 61% HBV rebound, no functional cure
> 3 log10from baseline (typically 1 –0.00 IU/mL): 97% HBV functional control / cure** With completion of th
AB-506 data: NO SAE, 2.0-2.8 log DNA reduction, 2.4log RNA reduction, 4/24 Grade 4 ALT flares with 1 HBsAg/HBeAg reduction of 1.4log 2.0log. Not drug induced liver injury (DILI), Possible immune mediated. to do 28d in healthy volunteers to confirm flare reason. Next day: 10% sell on news on small volume. Data seen as "intriguing"
ABI-H0731 no ≥3 grade flare. No new flare on treatment. No HBsAg reduction. About 2.0log RNA reduction, less on lower dose.
min Mcap 2.02B medium 3.86B
$ADPT TCR sequencing 06.2019 IPO
$MOR MorphoSys Antibody Partner of Xencor
$CRON first cannabis listed on NASDAQ 02.2018
$EBS a broad biologics company
|ETON||2019 new IPO. Generic formulation company. Little information on technology platform. CRL EM-100||2019-07-14|
|AMRX||a company put stock quote on front page. Indian background. slogan "make healthy possible". generic business. lower revenue guidance. Poor stock performance since 2015, down 90%+||2019-07-14|
|AMGN||$NVS discontinues BACE1 inhibitor CNP520 for Alzheimer's prevention||2019-07-14|
|ITCI||mixed Ph3 results on lumateperone for major depressive episodes associated with Bipolar I or Bipolar II disorder. Down 17%||2019-07-14|
|Elysium||8 nobel prize winner advisory board, flop?||2019-07-14|
|HOOK||Hookipa engineered ArenaVirus to deliver tumor antigen to DC to induce anti-cancer immune response. IND cleared for HB-201 HPV-positive cancer. Lots of buzz word "supercharge" "nobel prize". Flop?||2019-07-14|
|SLGL||Sol-Gel silica microencapsulated drugs for slow release to overcome side effects of drug direct contact. Released successful Epsolay microencapsulated benzoyl peroxide cream, for the treatment of papulopustular rosacea||2019-07-14|
|ILMN||revenue miss, guidance lower due to array business weak. down 17%||2019-07-12|
|Biotech||review BIIB/CELG/GILD/AMGN/REGN historical P/S ratio, at low level||2019-07-11|
|TSLA||might have topped, triple top break down $250, find support at $175, bounce back in small volume, to fill gap at $38?||2019-07-11|
share price ran down sharply to $3. Anticipated raise come 3 days after my reading. Priced $2.78 for $12.2M proceeds (need to raise again in half year?)option fully exercised increase to 5.05mil shares, net proceeds $13.0M
|ACRX||Credit Suisse initiated with $7 target. up 10%||2019-07-10|
finished reading 10K FY18. Great products, same efficacy, less side effects, more convenience and tech assisted compliance, microStat+microTears 2020 -> microProst for IOP lowering 2021 -> MicroPine 2023
01.30 - 02.25.2019 MIST-1,2 success to file NDA for mydriasis in 2020, one year delay due to manufacture batch stability data requirement.
expand microProst to CACG OAG OHT patients. The only with all three.
Management experienced. CEO Sean Ianchulev, MD MPH Key.
Next miles stone: microTears reg, MicroStat NDA 1Q20, Approval 2H20, launch both MicroStat and MicroTears 2021, MicroProst results 1H23.
only 14.3 mil left (2 quarters of cash burn), need to raise capital soon.
Founder Fredric Eshelman, co-founder Sean Ianchulev.
|CRVS||targeting Adenosine-Cancer Pathway tumor -> adenosine -> AA2R on T cells||2019-07-06|
|UMRX||Antibody coupled T cell receptor ACTR (CD16 Fc domain + 4-1BB + CD3z) + Rituximab for r/r CD20+ B cell NHL. FDA put on clinical hold after severe adverse event. I feel CD16 Fc not a good safe strategy.||2019-07-06|
|AMRN||increase revenue guidance and up sales efforts||2019-07-06|
|KPTI||selinexor, FDA compromised with a conditional approval as 5th line therapy for RRMM after AdCom and PDUFA delay. Continued approval will depend on Ph3 results||2019-07-06|
|Hanmi||Korean pharma company, full of failure and scandals, big pharma ends all deals||2019-07-04|
|ABUS||sold royalty to OMERS for $20m. Will revert back after $30m. 1.00-2.33% LNP licensing + undisclosed Acuitas royalty not included. extend 1 quarter cash burn||2019-07-02|
|ACRX||added to Russell 2000 & 3000 indexes||2019-07-01|
|ABUS||hearing transcripts out||2019-07-01|
|Semma||animal studies in primate and pig show their device protected stem cell-derived islets. Clinical trial next step||2019-06-30|
|SRPT||up 17% $PFE PF-06939926 AAV9 mini-dystrophin had 1/6 patient had severe antibody response||2019-06-30|
|CNAT||new failure emricasan in NASH cirrhosis. quit. CTS-2090 pipeline caspase 1 inhibitor. $NVS Novartis had $50 upfront deal.||2019-06-30|
|NERV||success Phase 2b seltorexant (MIN-202) for insomnia. chart not so interesting. Better than Ambien. marketing challenge.||2019-06-30|
KB103 (bercolagene telserpavec) topical gene threapy, for Recessive Dystrophic Epidermolysis Bullosa, or RDEB. Ph2 success. 5/6 wound closed. Raise $100M. A topical gene therapy company with STAR-D platform for skin gene therapy. KB105 IND initiated for TGM1-deficient ARCI. 2017 IPO at $10. Very successful so far.
|ACER||FDA CRL on EDSIVO™ (celiprolol) for vEDS. additional trial required. It was repurposed on market beta blocker drug originally developed for hypertension. ||2019-06-30|
|ACRS||ATI-502 JAK1/JAK3 Inhibitor Topical failed Alopecia areata, an autoimmune disease that results in partial or complete loss of hair.||2019-06-30|
|DOVA||Back up trend after FDA approves sNDA. Avatrombopag (Doptelet) oral small-molecule thrombopoietin receptor (c-Mpl) agonist. Approved May 2018, low revenue, management shake off in December 2018. Need to read more about commercial progress. ||2019-06-30|
|ONCS||1-to-10 reverse split after PhIIb failure. Deal the Dana Farber on bispecific CAR-T||2019-06-30|
|ZGNX||Resubmit Fintepla (ZX008) without the inclusion of the new chronic toxicity studies discussed with the FDA a root cause analysis to explain the incorrect clinical dataset||2019-06-30|
|ABUS||$SCYX SCY995 NTCP receptor inhibitor against HBV entry||2019-06-29|
|P/C||42 <=1; 130<=2 ( 519 biotech only)||2019-06-28|
more insider buy small amounts. increased authorized shares to 200M from 100M, hopefully they don't need that much. up 20%. REF
|CHMA||OPTIMAL trial results now expect mid Q3; MPOWERED trial 2H2020; added to Russell 3000||2019-06-28|
|DVAX||TLR9 actually protects mice from cardiac rupture after myocardial infarction in mice independently of inflammation.||2019-06-27|
|ACRX||read about abuse concerns and REMS ||2019-06-27|
|Biotech||Gottlieb goes of BOD $PFE Pfizer||2019-06-27|
FED cool off rate cut expectation. Sell off good economy
listen to JMP fireside chat, AB506 no HBsAg, 729 once monthly, 452 hope, oral PD1L to boost immune response in some patients (antibody may be too long PKPD with side effects). Small molecule PD1 inhibitors, Immunotherapy review, PD1 -HBV human trial 9-14% sAg response PPT
|ABBV||buy Allergan 63B deal: 1 $AGN worth 0.8660 AbbVie and $120.30 in cash. Analysts pessimistic no synergy. Was $PFE target Peak $330 in 2015. Drop to $114.||2019-06-25|
|AGRX||AdCom meeting scheduled for 10.30.2019. Sell on news to fill the 90c gap? Yes, down next day.||2019-06-24|
|ABUS||read about motion to strike arguments. still confusing. new broad argument theories, no time to test and reply. Morgan Chu was lately recruited to represent $MRNA. Unconfident?||2019-06-22|
|MLNT||FDA accepted sNDA for Baxdela in community-acquired bacterial pneumonia (CABP). PDUFA October 24, 2019. +198%||2019-06-22|
|ARCT||LUNAR mediated delivery of RNA into cells. Expand deal with Ultragenyx $RARE discover and develop mRNA, DNA and siRNA therapeutics $6m upfront 2.4m shares at $10 equity investment||2019-06-22|
|OCUL||FDA approved sNDA for Dextenza in ocular inflammation following ophthalmic surgery. Well before PDUFA 11.10.2019||2019-06-22|
|AMAG||Vyleesi (licensed from Palatin $PTN) approved by FDA for hypoactive sexual desire disorder (HSDD) in premenopausal women.||2019-06-22|
|BYND||Beyond Meat plant based meat los angeles based. IPO $25. reach $201. 700%+||2019-06-20|
|ABUS||AB-729 to initiate Ph1 after revising protocol, up 60%||2019-06-20|
|BHVN||$300 mil offering wipe out buyout speculation, 30% and 1b market cap||2019-06-18|
Xi Agrees to "extended meeting" Trump at G20, market break out upwards. I was right. Decline in fear, rise in news. #FTD Follow through day.2019.6.29 Truce agreed. Continue to talk. Future up 1%.
$SLS Galinpepimut-S (NeuVax) cancer vaccine failure on failure
$INSY bankruptcy lawsuit and fraud
mostly junk companies
$CRMD see log Neutrolin a non-antibiotic anti-infective for catheters.
$CHMA my watchlist anticipating pending Ph3 results
$AMRN same catalyst and flat since last watch
$AXSM see log: AXS-05 success. chiral chem, metabolism combo, carrier chem. neurology drugs
short list, poor sector performance.
|AGRX||CEO 20,000 shares 6.10.2019 #insider||2019-06-17|
|ACRX||CEO bot 5,000 shares 6.5.2019 #insider||2019-06-17|
|VYGR||$SNY sanofi give up rights to Parkinson’s disease program after FDA refused to review Ph2 and demand Ph3 trials. Still up 10% on $ARRY news||2019-06-17|
|ABUS||William Collier (age ~60 undergrad 1978-1981) from VIIV Healthcare to replace Mark Murray as President and CEO, too bad I don't have new cash to add||2019-06-17|
|BGNE||$BMY terminated $CELG PD1 deal with $150m fee||2019-06-17|
|VBIV||$DVAX competitor fails 2 dose secondary endpoint succeeds higher protection rate, esp in diabetes smokers||2019-06-17|
|ARRY||11.4B deal by $PFE 62% premium||2019-06-17|
PPAR agonist seladelpar for NASH failed to reduce liver fat. -45% . Biopsy pending in mid 2020. Competitive landscape crowded. $GNFT also has PPAR. $ICPT Obeticholic acid (OCA) targets Farnesoid X receptor (FXR) better for now. $MDGL
|ACHV||missed 1 of 4 arms in Ph2 trials. Down 32%. Achieve Life Sciences bring Cytisinicline to US, a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. established smoking cessation treatment in Central and Eastern Europe 20+ years.||2019-06-15|
|SYBX||$80m equity investment from Ginkgo Biowork. Company Designing Synthetic Biotic™ Medicines. SYNB1020 converts ammonia to arginine||2019-06-15|
Molgradex an inhaled formulation of recombinant human GM-CSF, failed to spur significantly improved treatment outcomes for patients with a rare respiratory disease called autoimmune pulmonary alveolar proteinosis, or aPAP. Management tout patients reported life quality improvement.Other pipeline: inhaled vancomycin and other antibiotics
teplizumab Ph2 type I diabetes success, median 2 year delay in high risk children and adults. up 169% week. binding of PRV-031 to CD3 triggers events that differentially inhibit the activation of self-reactive T cells, without affecting regulatory T cells. This restores the important state of immune tolerance and may prevent self-reactive T cells from attacking beta cells in the pancreas. If administered shortly after T1D diagnosis, PRV-031 has the potential to intercept the T1D disease process and slow or prevent the complete destruction of insulin-producing pancreatic beta cells.
|ARQL||ARQ531 more success overall response rate (ORR) of 66% (4 responses in 6 evaluable patients) in heavily pretreated relapsed or refractory chronic lymphocytic leukemia (CLL).||2019-06-15|
|CPRX||sue FDA for bowing to drug pricing pressure||2019-06-12|
|DVAX||ClinicalTrials.gov update SD101 and DV281 trials now active not recruiting. Planned cohorts scraped. ||2019-06-11|
|ABUS||Replicor presents final REP 401 data demonstrating persistent functional cure (40%) of HBV, 43% functional control. So the strategy works.||2019-06-10|
|XERS||a formulation company. The solutions or suspensions formulated using our technology have high stability and solubility. NDA of Gvoke (ready-to-use glucagon injection) by three months to September 10, 2019. -22%||2019-06-08|
first-in-class antibody targeting the complement activation product C5a failed Ph2b IFX-1, in moderate to severe Hidradenitis Suppurativa (HS) 化脓性汗腺炎 down 91%
|MTFB||FDA formally demanding additional trials for iclaprim ABSSSI after CRL||2019-06-08|
|BHVN||cancel Goldman Sachs Global Healthcare conference. speculate company sale coming||2019-06-08|
LJPC-401 in patients with hereditary hemochromatosis (HH) met Ph2 interim. up 139%. synthetic human hepcidin. Hepcidin, an endogenous peptide hormone, is the body’s naturally occurring regulator of iron absorption and distribution. In healthy individuals, hepcidin prevents excessive iron accumulation in vital organs, such as the liver and heart, where it can cause significant damage and even result in death. La Jolla is developing LJPC-401 for the potential treatment of iron overload, which occurs as a result of primary iron overload diseases such as hereditary hemochromatosis (HH), or secondary iron overload diseases such as beta thalassemia, sickle cell disease (SCD) and myelodysplastic syndrome (MDS)
|AMGN||AMG-510 KRAS G12C inhibitor 5/10 PR, ORR 50% up 3.4%. $MRTX MRTX849 up 47%||2019-06-08|
the sharp decline looks scary. After careful review, I don't think the market has peaked or a bear is coming. So many stocks has been consolidating for years. Sharp decline of ABUS ACRX DVAX are scary but too sharp to last.
2019.06.10 update: $INDU a follow through day, a bullish Kilroy consolidation. Consolidation is driven by threat of trade-war. Will be solvable.
|AGRX||initiated at Oppenheimer target $5 citing regulatory box checked, potential to expand patch market||2019-06-07|
|Portfolio||down -51%, loss $51k, overall loss $75k. Had profit with ABUS 200%, DVAX 100% ACRX 60% AGRX 20%.|
reduce debt, raise cash when 1) high 2) at resistance 3) gap behind, exhaustion gap ($DVAX) 4) negative news could come 5) positive expectation may not come especially for $DVAX and $ABUS
|AGRX||expect AdCom announce ment in July-August for a September-October meeting||2019-06-06|
|BigPic||a little panic today after $ACRX liability problem. $CPC #GapIndex reaching climax, $VIX still calm.||2019-06-03|
2mg ORR improved from 70% to 76% (34/45) with 8/45 CR (18%). 2mg 18m PFS 72%. $BMY perhaps can buy SD-101 and combine with NKTR-214 that has excellent CR but mediocre ORR.
|ACRX||25mil new debt including payment of 9mil old debt; I am seriously concerned about failure of Zalviso in Europe and its consequences (bankruptcy).||2019-06-03|
|NKTR||response remains 53% but 4 new complete response (13/38). really deepening response. up 12%||2019-06-03|
|BMRN||three-year data from its Phase 1/2 trial of valoctocogene roxaparvovec, for adults with severe hemophilia A. efficacy still impressive with durability dropping||2019-06-01|
|AMRN||Vascepa (icosapent ethyl) pure EPA Omega-3 derivative priority review for sNDA||2019-06-01|
|KZR||Kzr-616, a selective inhibitor of the immunoproteasome, blocks the disease progression in multiple models of systemic lupus erythematosus (SLE). Both safety and efficacy data were disappointing. two healthy volunteers who received the 60 mg dose required hospitalization||2019-06-01|
|CARA||CR845 Kappa Opioid Receptor Agonists (KORAs), provide pain relief (peripheral opioid analgesia) without producing significant CNS and mu-opioid mediated side effects. met the primary endpoint in its Phase 3 KALM-1 pivotal trial of Korsuva in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP)||2019-06-01|
|ZFGN||ZGN-1061 (METAP2 inhibitor) clinical hold still after type A meeting with FDA, working on animal model||2019-06-01|
|DVAX||disappointing SD-101 in HNSCC 24% ORR 2mg worse than 8mg barely better than PD1 alone, poster says "not mature", many had only one scan, but not on-going. May not improve over time.||2019-06-01|
|AMGN||Porges praise KRAS:G12C program|
Moderna has mRNA-5671 for KRAS mutation mRNA vaccines
JNJ team with wellsprings (Yi Liu San Diego) for small molecule KRAS:G12C inhibitor
Brad Loncar preview ASCO19:
|Biotech||executive sentiments lower, but not yet the worst||2019-05-28|
|Biotech||top 10 blow off of 2H18||2019-05-28|
|NKTR||spin out opioid, may not be as successful as touted||2019-05-28|
|ACRX||add 617@$2.628, $1621.5. Gap filled.||2019-05-28|
|TOCA||Independent Data Monitoring Committee (IDMC) recommended that its Phase 3 Toca 5 trial evaluating Toca 511 and Toca FC in patients with recurrent high-grade glioma (HGG), to continue through to final analysis. Investors had hoped that the trial would be stopped due to sufficient efficacy. Shares closed the week down 48% to $4.59 on the basis the lack of efficacy in the interim analysis will also be reflected in the final analysis due towards the end of this year.||2019-05-26|
|OCUL||my old target, did very poorly ever since. failed Ph3 OTX-TP, for the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension||2019-05-26|
|BCRX||oral BCX7353 for the prevention of hereditary angioedema (HAE) attacks, less efficacy than expected, may not be competitive. Was $IDRA merge target||2019-05-26|
|ARRY||Braftovi (encorafenib), Mektovi (binimetinib) and Erbitux (cetuximab) for colorectal cancer, met OS and ORR||2019-05-26|
|NVS||FDA approved Zolgensma, the first gene therapy for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA). Novartis will price Zolgensma at $2.125m, or an annualized cost of $425,000 per year for five years.||2019-05-26|
|DVAX||I want to add that these SD-101 trials are the "only" trials Dr. Antoni Ribas is presenting at ASCO19. He is a big name in immunotherapy. He just got elected president-elect at AACR. Like you said, I wish he does not go to ASCO19 just for the embarrassment.||2019-05-25|
|BGNE||178 mil quarterly R&D ... waiting for gap fill around $50||2019-05-24|
|DVAX||$175mil loan was a red flag, no partnership for 1.5 years, could not raise enough by offering. High debt is bad.||2019-05-24|
|AGRX||resubmission accepted in 5 days. PDUFA 11/16/2019. 6 months review. Potential AdCom in August to October||2019-05-23|
|ABUS||near cash again if not considering convertible notes. Sentiments very negative. oral argument 6.6.2019||2019-05-23|
divest immuno-oncology programs to focus on vaccine business, CEO Eddie Gray to retire. Layoff 37% staff.
|MRK||$1.05b for Peloton Therapeutics, $1.15b milestones. PT2977 targets hypoxia-inducible factor-2α (HIF-2α). Big Deal overdue||2019-05-22|
|MGTX||Ph1/2 dose escalation of AAV-RPE65, for the treatment of RPE65-deficiency, a condition that causes blindness, success||2019-05-20|
|INSY||opioid company INSYS pending bankruptcy due to opioid market (fentanyl) decline and lawsuits||2019-05-20|
|IMGN||FDA has requested the company conduct a new Phase 3 trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with ovarian cancer. Its previous FORWARD I trial did not meet the primary endpoint.||2019-05-20|
|MYOV|| Ph3 relugolix for uterine fibroids met its primary endpoint, but shares -28% due to Abbvie Elagolix competition||2019-05-20|
|ADVM||FDA lifted clinical hold on ADVM-022 for 2nd cohort in its Ph1 for wet age-related macular degeneration (wet AMD).||2019-05-20|
|DVAX||$6 gap closed||2019-05-20|
|AGRX||resubmit Twirla. no pop. -3.42%. Get ready for next week||2019-05-17|
$IOVA 44% ORR for its TIL therapy LN-145 in 27 evaluable cases of advanced cervical cancer
|DVAX||abstract old data except 2mg HNSCC encouraging: 2CR 3PR (n23) at first scan vs 8mg 6PR (n22) multiple scans||2019-05-15|
|ISEE||$OPHT rebranded to IVERIC BIO to focus on gene therapy. No reverse split yet.||2019-05-11|
|AXSM||substantial gain after AXS-05 success. chiral chem, metabolism combo, carrier chem. neurology drugs hard to understand||2019-05-11|
|FGEN||roxadustat, for anemia in chronic kidney disease (CKD), "no clinically meaningful difference in risk of MACE between roxadustat and epoetin alfa". So not safer than SOC||2019-05-11|
|QURE||more promising data on Phase 2b AMT-061 for severe and moderately severe hemophilia B||2019-05-11|
|CPRX||FDA to approve Ruzurgi by Jacobus Pharmaceutical Company for Lambert-Eaton myasthenic syndrome (LEMS) in children. $CPRX competitor||2019-05-11|
|FLXN||ZILRETTA is an extended-release corticosteroid approved to manage osteoarthritis knee pain. It is not intended for repeat use. approval from the U.S. Food and Drug Administration on October 6, 2017 and the company initiated the full commercial launch on November 20, 2017. Similar time to Heplisav Q4 2017: 0.36M 2018 revenue: 2.2 3.8 7.0 9.5; 19: 10.6||2019-05-11|
|PBYI||earnings miss 46m vs 66m estimate||2019-05-11|
online article on patent dispute: PTAB has not yet made any final decisions, and it has explicitly reserved certain highly material factual issues for later determination. The IPRs thus remain worth watching.
US-China talk may not reach a deal; Fed may step in, yet will be disaster; Trump will be re-electedUpdate 5.10: talk continues with 25% tariff on.
|ABUS||read about CEO pay, top CEOs get 15-25 mil, Mark Murray got 500k salary + 1.6mil options||2019-05-09|
|DVAX||read DV281 poster again, patients were pretreated, 20/23 were treated with PD1 or PD1 chemo combo.||2019-05-09|
Zalviso resubmission by YE19, pending REMS and Europe data. No hospital declined. Diverse use. ERAS. ER efficiency: keep vertical, no witness needed for disposal leftover
Q: ASC, 5 of 46 approval other ongoing, REMS not a problem for hospital. Non-invasive, flat PK, opioid shortage continues. Investigator initiated ERAS trial pending. Initial revenue mostly whole saler. Approvals came in April.
We have performed a variety of studies in vitro to look for signs of toxicity or other off target effects. We cannot find them. The compound looks clean. We have knocked out several cellular proteins involved in the mechanism, there appears to be no deleterious effects on the cells. And finally we have made a competitive position in this space and we'd like to maintain that with the first RNA-destabiliser to the clinic.
1. Changed Vehicle. "what I can say is that the vehicle we used was really somewhat unusual." - Sofia going standard vehicle
these vehicles are - are only used in animal studies, they're not used in humans. We have solid dosage formulations for human studies. If we are able to move forward.
2. AB729 package enough for healthy, wait study results for HBV patients
3. AB506 not expecting HBsAg effect
|DVAX||CC: 2-dose causes a hurdle for change: Protocols and EMRs, 2-dose needs to be marked as complete.|
no new oncology commitment before partnership deal by mid-year?
new CKD study is to find the right dosing regime than new additional patients.
ASCO: 2mg PD-1 resistant; 2mg HNSCC
Inventory growing as demand grows
557/1420 yes, 863 nos. Nos are small number, not permanent, some converts, we keep in touch. One had wrong price to P&T.
|DVAX||sales slow, $30m covenant should easily met. Moving into new bigger office and lab space. 1, 2. 41k -> 76k sqft.||2019-05-08|
|ACRX||Q1 minimal revenue. ambulatory surgical center network with over 300 locations. "On track"?||2019-05-08|
|RGLS||New private placement of equity, term loan restructure, $MGEN miRNA no signs of turning around||2019-05-07|
|IDRA||AACR19 Tilsotolimod monotherapy data: 13/29 45% SD, 5 maximum tumor shrinkage >10%, duration of SD 1.3~9.7+ m||2019-05-06|
|DVAX||new Heplisav-B trial on end stage dialysis kidney disease patients||2019-05-06|
|ABUS||1Q19 CC PR: Delay, delay, delay ...|
AB-506 delayed from Q2 to July
AB-729 delayed from Q2 to unknown
AB-452 go/nogo decision delayed from H2 to early 2020. the nonclinical safety study resulted in several confounding observations which included clinical observations with no histological correlation, a lack of dose response regarding some key findings and an unexplained vehicle effect. Because of these confounding observations, we have determined that repeating the 90-day preclinical safety study in two species is appropriate before making a go/no-go decision.
|HRTX||CMC & non-clinical CRL HTX-011 for the management of postoperative pain. Competitor $PCRX up||2019-05-05|
|NBRV||CMC CRL of Contepo (fosfomycin) antibiotic for complicated urinary tract infections (cUTI). ||2019-05-05|
|VTGN||AV-101 failed phase 2 treatment-resistant depression (TRD). ketamine is a classic channel-blocking NMDA receptor antagonist. AV-101 is a NMDA receptor GlyB antagonist that inhibits NMDA receptor function rather than blocking it. We believe this difference (modulating NMDA receptor activity rather than blocking it), together with the activation of AMPA receptor pathways, can potentially bypass the adverse side effects that occur with ketamine while still achieving fast-acting ketamine-like antidepressant effects.||2019-05-05|
a common example of a nano/mirco cap company announcing largely insignificant news, in the hope of garnering the attraction of day traders, and following it up with an offering to raise cash through the sale of shares and warrants, taking advantage of the price spike.
Annamycin: The Next Generation Anthracycline for AML, and lung cancer mouse model. Other pipeline candidates MOA not clear/disclosed
down 21% to $10.79 offering 6.5m share @$11.50 $ABUS LNP licensee went IPO in 2018.11. work on neoantigens
|CTRV||ContraVir $ABUS competitor CRV431 cyclophilin inhibitor not doing well. Penny stock. Just offered 0.12 per share for total proceeds of $2.14m. $ABUS discontinued cyclophilin progam in Oct 2015. Promised a lot at 2015 for 2016, 2017, but significantly delayed now at 2019. cccDNA program in lead optimization||2019-04-27|
|RGEN||long time ago they failed this target therapy. now back with C Technologies buyout, a biomanufacturing analytics company.||2019-04-27|
|ALKS||schizophrenia drug, Aristada. Revenue disappoints of $30m v. guidance in February $40m. down 13%||2019-04-27|
|Politics||MD Anderson oust three Asian researchers due to foreign connections||2019-04-24|
|Biotech||late stage productivity is rising fast and most are due to emerging biopharma not big pharma||2019-04-24|
RX-1117 only activated by UCK2, high in tumor cells. then acts as nucleotide analog, kills that cell. Deal with BioSense China. Nano cap. Reverse Split.
|FCSC||FCX-007 Col7 gene therapy small deal with Castle Creek Pharmaceuticals with 7.5mil upfront. Nanocap. Reverse Split.||2019-04-21|
|MBIO||data released in May 2018, published on NEJM. share price down 60% since data release, but up 112% for NEJM. Gene therapy cured XSCID "Bubble Boy" in 3-4 months.||2019-04-21|
|WVE||Phase 2/3 patients will receive only 3 mg/kg or 4.5 mg/kg doses of suvodirsen, low dosage too low to show sufficient efficacy and higher doses not possible due to safety.||2019-04-21|
|ABUS||combo strategy is not a reason for price unless proven by data. LNP deals did not come as expected.||2019-04-19|
|ASMB||core-inhibitor ABI-H0731 show 2.x log HBV DNA RNA reduction, but no HBeAg HBsAg reduction||2019-04-19|
|Immune-onco||‘Patients are not a company’s resource’: FDA cancer czar Richard Pazdur warn top R&D execs; call for collaboration, reduce harm and waste||2019-04-18|
|Biotech||healthcare sector crashing today despite new high in big market; made the right decision to wait for gap fill; "Medicare for all" scares healthcare sector||2019-04-17|
|Biotech||#FDA acting commissioner Ned Sharpless not playing with the FDA’s gold standard, continue Gottlieb's policy||2019-04-17|
|AKAO||bankruptcy, no revenue half year post approval. Was a $2B company. Antibiotics is a bad business||2019-04-16|
|AMGN||Evenity price $21,900/y, compete on monthly dosing and 1 year course; Cons: high CV risk, non-vertebral reduction soso||2019-04-16|
|UTHR||licensed from Lung Biotechnology esuberaprost Beraprost 314d modified release (BPS-314d-MR) is a single isomer prostacyclin analogue oral tablet. Miss Ph3 endpts in pulmonary arterial hypertension (PAH)||2019-04-13|
|TCON||TRC105 (carotuximab) antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis. Phase 3 TAPPAS trial evaluating TRC105 in combination with Votrient (pazopanib) in patients with advanced or metastatic angiosarcoma was terminated for futility. Other TRC105 trials terminated.||2019-04-13|
$DVAX 200k shares sold in last 3month
$ACRX heavy buying from all officers around 2.7~2.9 in Feb
$AGRX Buying by 2 insiders on 3/29/2019, multiple options executions
a delay in readouts from its two ongoing Phase 1b/2a clinical trials evaluating WVE-120101 and WVE-120102 for patients with Huntington’s disease (HD). 1 month ago says this quarter, now delayed to YE. Poor enrollment. Both drugs are antisense oligonucleotides (ASO) against HTT gene
|ZGNX||Fintepla (ZX008) refused to file. dataset missing or incorrect||2019-04-13|
|PHAS||BTD for PB2452, a reversal agent for the antiplatelet drug ticagrelor||2019-04-13|
|CMRX||antiviral medicines for patient with weakened immune systems. got Michael A. Sherman, former CEO of Endocyte||2019-04-13|
|BHVN||exploring a sale of the company, oral CGRP inhibitor, $AMGN $NVS Aimovig doing well||2019-04-13|
|SBPH||Inarigivir Ph2 results 1.5log DNA reduction 1.1 log RNA reduction, 26% see >0.5 log HBsAg reduction with a mean of 0.8log. select 400mg for Ph3||2019-04-12|
|DVAX||HDAC inhibitor poster||2019-04-11|
|BGNE||deal with San Diego-based BioAtla BA3071, a CTLA-4 blocking “conditionally active biologic” that gets turned on or off based on whether it’s inside the tumor microenvironment.||2019-04-09|
|AMGN||Romosozumab (Evenity) FDA approval despite CV risk||2019-04-09|
|AMGN||$NVS breach partnership by partnering with Alder||2019-04-08|
|Immune-onco||exosome carries PD-L1 away||2019-04-08|
$MNK FDA Rejects Mallinckrodt’s Abuse-Deterrent Opioid Painkiller MNK-812
$MTFB $ADMA $IMMU $ALKS $TRVN $AQST $LXRX $REPH $EVOK
$SBPH Inarigivir RIG-I $ASMB core inhibitors cccDNA inhibitors $ALT HepTCell
|MACK||MM-310, EphA2 receptor targeted nanoliposome Docetaxel ADC, discontinued for solid tumors||2019-04-06|
|REPH||50% reduction in employees||2019-04-06|
|EVOK||Gimoti CRL, intranasal formulation of metoclopramide, for acute and recurrent diabetic gastroparesis||2019-04-06|
|ADMA||FDA approved Asceniv (RI-002, 10% IVIG) for Primary Humoral Immunodeficiency Disease.||2019-04-06|
|SGMO||up 32% to $12.58 interim data Phase 1/2 Alta trial SB-525 gene therapy for severe hemophilia A. ||2019-04-06|
|ABUS||submitted Objection to Evidence in patent dispute against Janoff's opinion||2019-04-04|
|DVAX||DV-281 data not so exicting. There is no response (CR/PR) in 20 evaluable patients. The SD/PD ratio is the same as the before the treatment. So we don't know if DV281 did anything at all, or just PD-1 did its job. ||2019-04-02|
|PTI||Proteostatis disappoints triple combination trial of PTI-428, PTI-801 and PTI-808, for cystic fibrosis.||2019-04-01|
|CANF||Can-Fite fails Ph2 liver cancer. Gi protein coupled A3 adenosine Technology Platform - A3Areceptor (A3AR) is highly expressed in inflammatory and cancer cells. Company make A3AR agonists||2019-04-01|
|ALDX||reproxalap (RASP inhibitor to reduce aldehyde) for allergic conjunctivitis met Ph3 primary endpoint.||2019-04-01|
|OSMT||Arbaclofen, or R-baclofen, acts upstream of the mGluR5 receptor to increase inhibitory neurotransmission. met just 1 of 2 endpts in 2nd Ph3 spasticity in Multiple Sclerosis (MS)||2019-04-01|
|FCSC||promising wound closure rates of 63% from its ongoing Phase 1/2 clinical trial of FCX-007, market sold on new.||2019-04-01|
|GLPG||$GILD partner Phase 3 filgotinib (JAK1) in adults with moderately-to-severely active rheumatoid arthritis more success||2019-04-01|
|TCDA||Tricida veverimer met Ph3 CKD. TRC101 is a novel, non-absorbed polymer that is designed to treat metabolic acidosis by binding hydrochloric acid in the gastrointestinal tract and removing it from the body through excretion in the feces, thereby decreasing the total amount of acid in the body and increasing blood bicarbonate||2019-04-01|
|PRTO||vonapanitase fails Ph3 CKD. Exact mechanism unknown, perhaps vonapanitase fragments elastin fibers in the vessel wall and thus may augment endogenous elastase activity in the fistula. ||2019-04-01|
|DVAX||EMA Heplisav-B submission||2019-04-01|
|CHMA||offering 6.3mil shares at $4.75||2019-04-01|
|REPH||IV meloxicam for pain, 2nd CRL||2019-03-24|
|LXRX||$SNY SGLT2 SGLT1 dual inhibitor sotagliflozin CRL after 8-8 split AdCom||2019-03-24|
|UROV||Ph3 vibegron for overactive bladder success. 220% pre-data release run, down 20% upon news||2019-03-24|
|SAGE||Zulresso (brexanolone) injection for postpartum depression (PPD). Approved.||2019-03-24|
|CNAT||fails biopsy-confirmed nonalcoholic steatohepatitis (NASH) and liver fibrosis||2019-03-24|
|ARPO||AKB-9778 a small molecule inhibitor of VE-PTP fails Ph2 non-proliferative diabetic retinopathy (NPDR)||2019-03-24|
|DERM||Phase 2b lebrikizumab (anti-IL13) for atopic dermatitis success. to compete IL-13/IL-4 drug Dupixent Regeneron/Sanofi||2019-03-24|
|DVAX||Extensive SD-101 clinicaltrials.gov registration update 4 new cohorts Q3W dosing match Keytruda. Previously weekly||2019-03-24|
|BIIB||Alzheimer’s drug aducanumab implodes in a PhIII disaster; but Eisai still believes it||2019-03-22|
|SPPI||withdrawn its Biologics License Application (BLA) for Rolontis (long acting G-CSF), compete Neulasta||2019-03-17|
|MCRB||Seres got $20M equity investment from $AZN 's immuno-oncology deal||2019-03-17|
|ZFGN||suspend IND ZGN-1258 (MetAP2 inhibitor), for rare metabolic disorders including Prader-Willi syndrome (PWS) due to tox||2019-03-17|
|AERI||Rocklatan 0.02%/0.005% to reduce elevated intraocular pressure (IOP) approved, no big change||2019-03-17|
|KPTI||selinexor, for relapsed refractory multiple myeloma, PDUFA extended by three months to July 6, 2019. ||2019-03-17|
|ATOS||Atossa Genetics Inc. misleading PR: making a 1-patient expand access approval sounded like marketing approval, up 400%||2019-03-17|
|BioNTech||to IPO raise $800mil with $4B valuation #Genevant $ABUS||2019-03-12|
|Biotech||NCI’s Ned Sharpless to run the FDA in wake of Scott Gottlieb’s surprise exit; expect favoring policy to continue||2019-03-12|
|AMAG||Hydroxyprogesterone caproate (OHPC), (Proluton and Makena), progestin to prevent preterm birth miss Ph4||2019-03-10|
|EVOK||Gimoti, intranasal formulation of metoclopramide, for acute and recurrent diabetic gastroparesis||2019-03-10|
|ASND||Ascendis once-weekly TransCon hGH success Ph3 in pediatric growth hormone deficiency (GHD) v. Genotropin $OPK||2019-03-10|
|ARQL||ARQ531 Ph1 success in B-cell Malignancies. BTK inhibitor designed to inhibit both wild type and C481S-mutant. FY18 CC||2019-03-10|
|SEEL||seelos nano cap in-licensed peptide inhibitors of alpha-synuclein for Parkinson. Rise in speculation||2019-03-10|
|BPTH||Prexigebersen (Liposomal Grb2 Antisense) for Acute Myeloid Leukemia (AML) show promising Ph2, plan to file NDA||2019-03-10|
FY18 CC launched Jan-Feb. expected formulary approval 100->125, accelerate Q4 sales hiring to Q3. Manufacture automation cost reduction and consolidation of Zalviso will help ex-US licensing. Zalviso US prident wait for REMS and more EU data for compliance and abuse. Sales team experienced, Physical therapy and burn patients, military talking, Enhanced recovery after surgery ERAS, timing P&T, embrace REMS
FY18 CC, AB-506 Ph1b data due Q2, AB-729 Ph1 Q2-Q419, AB-1467 discontinued. owns 40% Genevant. 85m shrs. Commit to RNA destablizer, take time to complete; Onpattro royalty nonmaterial this year, open to deal
|ONCE||bidding from 70 - 73 cutoff collab talk - 75 B - $450M C, upfront - 84 C - 91 Roch final - 105 C final - 114.5 Roche back||2019-03-07|
|ALNY||promising top-line Ph3 snapshot for givosiran for acute hepatic porphyria, but safety issues. Risk/Benefit? ||2019-03-07|
|Biotech||Popular #FDA ccommissioner Scott Gottlieb has handed in his resignation||2019-03-05|
|ACRX||flash crash bear raid, I resisted the tempt to look twitter for explanation. 25% intraday spread||2019-03-05|
|NextCure||Lieping Chen's new company. immune suppressor Siglec-15 (S15). Targeting S15 to overcome PD1 resistence||2019-03-05|
|BIIB||bought $NITE Nightstar Therapeutics 800M for rare inherited eye disease gene therapy, each could generate 100-200M/y||2019-03-04|
|AGRX||Private placement 8.4mil shares at $0.93 raise 7.8mil, no discount, confidence, total 43.5m shr. Target 60M, $40/share?||2019-03-04|
|KPTI||AdCom 8-5 recommend wait for Ph3 results selinexor for relapsed or refractory multiple myeloma, citing toxicity||2019-03-02|
|NVAX||ResVax RSV-F vaccine failed in pregnant mothers to protect infants 39-48% protection severe consequences||2019-03-02|
Horizon Pharma teprotumumab (anti-IGF-1R) for active thyroid eye disease (TED) met its endpoint, autoimmune inflammatory disorder: eye muscles and fatty tissue behind the eye become inflamed.
|TGTX||TGR-1202 umbralisib (PI3Kd inhibitor) meet ORR in MZL Ph2b||2019-03-02|
|IMGN||ImmunoGen mirvetuximab (anti-folate receptor alpha FRa) soravtansine IMGN853 ADC failed PFS for ovarian cancer. Endocyte/Merck vintafolide and Eisai’s farletuzumab have suffered the same fate.||2019-03-02|
|LXRX||sotagliflozin CHMP positive opinion after AdCom 8-8.||2019-03-02|
|PBYI||Back on track with Nerlynx Sales improvement 4Q from 20m to 60m||2019-03-02|
|ADRO||Strategic reset to focus on core strength: STING APRIL. Deprioritize CTLA4 SIRPa pLADD||2019-02-28|
|DVAX||#AACR19 domatinostat (4SC company) SD-101 combo further boosts response in mouse model||2019-02-27|
|BMY||8% stake largest shareholder Wellington oppose merger with $CELG 1) offering $BMY at too low price 2) execution harder than mgmt imagine 3) alternative way to create value.||2019-02-27|
down -10%, sentiment bearish; Nothing fundamental has changed. $DVAX still has the best I/O combo in clinic. Heplisav still the best Hep-B vaccine - improves response with 2-dose/1-month. TLR still the Nobel prize winning pathway that started the whole concept of "innate immunity". It seems all about business for now; science will prevail eventually. $IDRA is flat; so today's selling is mostly speculators selling on news. Nothing about TLR9.
|DVAX||FY18 CC: 1. not suitable for younger patients, no plan; 2. partnership deal pending 2mg data in HNSCC and Melanoma R/R trials 3. Q1 revenue could still be disappointing 4. lots of plan: EU, Pertussis, I-SPY2, HPV tumors, DV281 AACR ||2019-02-27|
|DVAX||Could $GSK be the long sought partner for $DVAX SD-101 program, given CEO Mr. Eddie Gray's tie with GSK?||2019-02-26|
|ICPT||Phase 3 trial of obeticholic acid (OCA) with liver fibrosis due to nonalcoholic steatohepatitis (NASH) meet fibrosis but not NASH resolution endpoints||2019-02-25|
|VYGR||deal with $ABBV AAV vectorized antibodies for Parkinson’s disease and other disorders of misfolded alpha-synuclein protein||2019-02-25|
|KPTI||selinexor oral XPO1 inhibitor, FDA briefing, slam their case on the efficacy of a cancer drug with “significant toxicity”||2019-02-25|
|DHR||Danaher to buy GE Life Sciences for $21.4B with $3B revenue||2019-02-25|
|CMTA||Clementia bought by $IPN Ipsen for upto 1.31B $25+$6CVR ($14.92previous close)||2019-02-25|
|BigPic||Trade dispute to be resolved. It is all about negotiation. Nobody wants trade war.||2019-02-24|
|BMRN||$2 million or $3 million per patient, 5000 pts per year capacity, $10-15B /year||2019-02-24|
Roche to buy Spark gene therapy for $4.3B, 122% premium
|NTLA||October 2018 data on LNP CRISPR+AAV gRNA $ABUS||2019-02-23|
|MRK||$IMDZ $DVAX clearly $MRK IS interested in activating DCs via TLR pathway AND intratumoral delivery route. However, TLR4, is a mediocre TLR target comparing with CpG-TLR9.|
1. TLR4 is on cell surface, TLR9 is in the endosome
2. TLR4 is less APC specific, TLR9 is DC specific.
3. TLR4 is a poor interferon inducer, TLR9 is excellent IFN inducer.
The first two points will lead to toxicity, and the last point may suggest inferior efficacy.
|XNCR||CD3 bispecific antibodies run into trouble with toxicity $JNJ $MGNX||2019-02-20|
|MRK||overdue for a deal, last one was with $STRO, a discovery biologics therapeutic protein, ADC, BiSpecific company ||2019-02-17|
|Clinigen||$CLIN.LN acquired Proleukin original IL-2 rights from Novartis||2019-02-17|
|Passage||Passage Bio got Penn and James Wilson for a startup AAV #genetherapy company after Wilson abruptly resigned from $SLDB||2019-02-17|
|DBVT||plans to resubmit 3Q19 after withdrawal in 2018.12. $AIMT already under review||2019-02-16|
|CLBS||Caladrius CD34+ and T-reg cell therapy. CLBS03 autonomous T-reg failed type 1 diabetes to protect recent onset residual beta cells||2019-02-16|
|MTFB||picked up failed drug ABSSSI antibiotic from Roche spinout Arpida in 2009, ran 2 Ph3 to show non-inferiority. FDA rejected again CRL, demanding liver toxicity data. Similar to $CEMP||2019-02-16|
|ACRX||gap up on credit suisse coverage||2019-02-15|
|BigPic||IPO market low, $WLSH $GapIndex break 200MA in rising volume||2019-02-15|
|AZN||dropped pipeline anti-OX40 MEDI0562 and dual TLR7/8 agonist MEDI9197 (too toxic even designed to stay in tumor). $DVAX||2019-02-14|
|DVAX||Usually announce CC 1 week ahead, This time announced 2 weeks ahead on 2.12 for 2.26 event.||2019-02-14|
|ABUS||More delays, still working on AB-452; AB-506 Ph1 data Q2. -4.88%||2019-02-14|
drug pricing. Only 1 drug company ($JNJ) in fortune 50, mostly due to its consumer business. 3 out of the top 10 and 8 of the top 50 most successful businesses in the world based on total revenue are health insurers, PBMs, or drug distributors. drug manufacturers only receive 39% of initial gross drug expenditures
|GILD||selonsertib (ASK1 inhibitor) fails Ph3 NASH $MDGL $VKTX||2019-02-12|
|MRK||TKI/IO combo in Renal cancer; priority review for HNSCC||2019-02-12|
|ABUS||#genetherapy AAV summary: AMT-061 liver FIX AAV5; SB-913 liver albumin promoter driven IDS AAV2/6; SGT-001 muscle microdystrophin AAV9.||2019-02-11|
|DVAX||Intalere (group purchasing and logistics) signs volume purchase pricing agreement with $DVAX||2019-02-11|
|AGRX||Twirla adheres non-inferior, potentially better than FDA approved Xulane. ||2019-02-11|
|QURE||AMT-061 update FIX level sustained up to 16 weeks after a single dose in all 3 patients. How durable is this in longer term? All 3 pts had pre-existing anti-AAV ab. No chance for redosing.||2019-02-09|
|SLDB||DMD dad's Solid Bio disappointing data Ph1/2 dose-ascending SGT-001 microdystrophin gene transfer. Low expression. This week two setbacks in AAV gene therapy: Sangamo's SB-913 for MPS-II and Solid Bio's SGT-001 for DMD. Both suffer from poor efficacy. AAV does not work. low dose -> poor efficacy, high dose -> toxicity, repeat dosing -> immune response. AAV guru James Wilson quit. LNP gene therapy is the future.||2019-02-09|
|SGMO||Gene Editting disappoints, dragging down peers. Had immune response, AAV vector||2019-02-07|
|MGNX||margetuximab anti-HER2 met Ph3. Not much details.||2019-02-06|
|XNCR||$160M IL-15 alliance with $RHHBY||2019-02-05|
|ACRX||$PTIE gave up on Remoxy||2019-02-05|
|BMY||Activist investor Starboard Value eyes on $BMY. may derail Celgene buyout and push for $BMY sale.||2019-02-04|
|GILD||Write down BCMA CAR-T, 900M, just the beginning of write downs 12B? Not enough revenue Yescarta despite first and best in class. Field moving on to off-the-shelf.||2019-02-04|
|ABUS||Lipid Nanoparticles Enabling Gene Therapies: From Concepts to Clinical Utility. (Nucleic Acid Ther. 2018)||2019-02-02|
|AQST||licensee Sunovion got a CRL for apomorphine sublingual film for OFF episodes with Parkinson's disease (PD)||2019-02-02|
|ACIU||AC Immune and Roche (RHHBY) is discontinuing Ph3 trials of crenezumab against human 1-40 and 1-42 Beta amyloid, for Alzheimer’s disease (AD) $BIIB||2019-02-02|
|AVEO||FDA rejects preliminary OS data VEGFR Tivozanib wait for mature interim OS data due 4Q19||2019-02-02|
|MGTX||$100 upfront from Janssen ($JNJ) on AAV Gene Therapy Treatments for Inherited Retinal Diseases||2019-02-02|
|TRVN||FDA will agree on labeling to a maximum daily dose of 27 mg for oliceridine for the treatment of pain relief. CRLed when ACRX approved. up 87% week.||2019-02-02|
|VYGR||Voyager AAV gene therapy deal with $NBIX $115m upfront and $50 equity. Parkinson's in Ph2||2019-02-02|
Eyenovia (2018 IPO) nanocap met the primary endpoint in its Phase 3 MIST-1 trial of MicroStat for the treatment of mydriasis (dilation of the pupil). Microdrop technology for precise eye drug delivery. #insiders buy small quantity since IPO
|FBIO||Fortress Biotech incubator's Caelum Biosci got $60m from $ALXN for CAEL-101 anti-Amyloid antibody for light chain (AL) amyloidosis, previously Prothena NEOD001 failed in a similar hypothesis.||2019-02-02|
|CTIC||Flt3 JAK2 dual inhibitor Pacritinib myelofibrosis EMA withdrawn||2019-02-02|
|ALKS||FDA CRLed ALKS-5461 after refuse-to-file, 2-21 AdCom, and horrible trial design, changes and poor efficacy.||2019-02-02|
|EOLS||FDA approved Jeuveau (Botox) for glabellar lines up 31% AH||2019-02-02|
|Biotech||6B cost per approval. Cannot recoup investment. Unsustainable model? Why exist, missing something?||2019-02-01|
|ADRO||Aduro to refocus on STING and anti-APRIL. Shelf LADD, CTLA4, SIRPa programs after GVAX, Listeria, and STING setbacks. Below cash.||2019-02-01|
|ACRX||to present in the first meeting upon launch, 41st Annual Boswick Burn & Wound Symposium (Feb 2-7, Hawaii)||2019-01-31|
|AMGN||biosimilars eat into Neulasta revenue, generic Sensipar coming; Repatha and Aimovig launch well; look at deals of all size||2019-01-30|
Big Pharma (represented by PhRMA) Should Accept Cap On Drug Price Increases by inflation rate. HHS may stand down proposal to link to international price. Uncertainty to the industry may be cleared soon.
|ADXS||FDA partial hold Ph3 axalimogene filolisbac (AXAL) of cervical cancer (AIM2CERV). additional information on AXAL CMC matters. ||2019-01-27|
|ABBV||Humira international sales -14.8% due to biosimilars||2019-01-27|
|BMY||sBLA for Opdivo combined with Yervoy for frontline NSCLC cases with high tumor mutational burden — or TMB withdrawn. new data reading needed||2019-01-27|
|EDIT||CEO Katrine Bosley resigned abruptly prior to initiation of key trial||2019-01-27|
Margrit Schwarz of Roche is coming to Genevant; Jackie Fouse left Dermavant; CFO set. up 12.8% on big volume.
|DVAX||Nat. Immunol. paper on CpG-TLR9 overcomes CD47 block||2019-01-23|
Cabometyx (cabozantinib) sNDA approved for HCC. tyrosine kinase inhibitor.
First approval in thyroid cancer in 2012, invested heavily in other cancer, failed prostate in 2014, laid 70% off, share price drop below $2. Won approval in Melanoma 2015, licensed to Ipsen in 2016, approval in 2016.04 for 2nd line Kidney cancer, 2017.12 for 1st line.
Kinase inhibitor leader. Indication expansion. 20x in 3 years. 7x in 21 months.
|TYME||SM-88, a modified tyrosine analog to be uptaken by cancer cells and mess up stop their protein synthesis. ||2019-01-19|
|AIMT||FDA will not commence review of its BLA for AR101, for peanut allergy until the shutdown has ended.||2019-01-19|
|VRNA||RPL554 dual inhibitor of PDE3 and PDE4 and stimulating the CFTR, fails COPD.||2019-01-19|
|LXRX||Lexicon's SGLT2 SGLT1 dual inhibitor Sotagliflozin receives 8-8 split AdCom vote due to increase in the risk of diabetic ketoacidosis (DKA). SGLT2 inhibitors are blockbusters. But SGLT1 also absorbs glucose. company MOA, DiabetesInControl.||2019-01-19|
|IMMU||David M. Goldenberg Immunomedics received CMC CRL. Rose from 2 -> 26. Now retrace back to $13. See 2017 drama||2019-01-19|
|LLY||Lilly’s approved cancer drug Lartruvo (Olaratumab, anti-PDGFR) fails confirmatory study in Soft Tissue Sarcoma, to withdrawal. $OPHT Fovista (pegpleranib, PDGF-B inhibitor) failed wet AMD.||2019-01-19|
|Alzheon||withdraw 2nd IPO attempt. 3mil cash left. 1st try $80mil. 2nd try $30m||2019-01-17|
|Citron||attacks $LGND for unfocused overstated pipeline and partnership. Attacked $ABBV (Humira) $ESRX $MKD (Acthar) to suffer from drug pricing pressure||2019-01-17|
|AMGN||Romosozumab 18-1 AdCom 1 against is patient wanting CV risk sorted out||2019-01-17|
NMDA modulator NYX-2925 fails in PhII neuropathic pain study
|DVAX||Heplisav-B available to Military; bullish SA article, negative comments||2019-01-15|
|JPM||JPM golden pill with golden DNA inside was stupid. Atlas venture partner Booth says farewell. Public company CEO defends its value. I agree with Booth.||2019-01-15|
|MRK||PD-1 reduce death risk 31% in esophageal and esophagogastric junction carcinoma subgroup: 222 out of 628 squamous cell carcinoma or adenocarcinoma, who had progressed after standard therapy and whose tumors expressed PD-L1. But not in overall or another subgroup: 401 patients with squamous cell carcinoma||2019-01-15|
|AMGN||Romosozumab CV risk OK at FDA briefing||2019-01-14|
|Pancreatic||Jim Allison paper about VISTA and stromal cells in pancreatic cancer||2019-01-14|
|LJPC||Giapreza angiotensin II for IV sales fall short again expect FY2019 $24-28mil||2019-01-12|
|INSM||Arikayce approved 09.28.2018 first quarter 4Q18 $9.7 mil sales. liposome for lung delivery to avoid charged enviroment in lung infection||2019-01-12|
|DVAX||OX40 paper: eradicates tumor unlike PD1 only delays; TLR7/8 not as great; Costco vs Sam's||2019-01-12|
Heplisav sales (mil):
|SAGE||Phase 3 success of SAGE-217 in women with postpartum depression (PPD); Ph2 success in YE2017; waiting for MDD||2019-01-12|
|AXSM||AXS-05 for major depressive disorder (MDD) Ph2 success. "right" mix of dextromethorphan and bupropion, but individuals are claiming some success by using their random mix of dextromethorphan and bupropion. Maybe a commercial problem. +180%||2019-01-12|
|MGEN||Cobomarsen miR155 inhibitor show some activity in TALL. but 20% sell off on this news||2019-01-12|
|Neoleukin||IL-2 computationally designed for IL2 b g receptor but not CD25 to reduce tox. $THOR||2019-01-11|
meeting minutes on wear study: ~80 healthy BMI<35 women crossover design 1wk Xulane 1wk Twirla vice versaassume: raise $25M (50M shares at $0.5 currently discounted price), $500M peak sales 4X PS, target price will be 2000/85 = $24/share
JPM19 slides, transcripts: Good:
* Solid Q4 vaccine sales 3.7mil +147%
* new Pertussis vaccine using 1018 in the pipeline
* EU EMA MAA 1H19
Not so good:
* the company now put "on our own" before "partnership": own PD1RR, HNSCC, I-SPY2, other HPV cancers, mostly 1Hor 2H19; PD1 naive ($150m, 700pts) multiple partner discussions
* SD-101 decision postponed to 1H19 after postponed to early 2019 from End of Year 2018
It seems DVAX has a hard time to get a partnership despite 70% ORR. I wish it is just good things take longer to develop.
|AMGN||$NVS NICE rejects migraine drug Aimovig, months after declining to endorse pricey Kymriah for adult use||2019-01-10|
|Cygnal||Developing exoneural treatments for cancer, immunological, and regenerative diseases, a Flagship venture, Roche exec Pearl Huang as CEO||2019-01-10|
|NKTR||surge above 50MA after JPM showing $1.85B cash and extensive trials and collaborations ongoing and planned||2019-01-08|
|DVAX||Sam's club deal represents chain pharmacy||2019-01-08|
|ABUS||$ALNY Onpattro (patisiran) 4Q sales $11-12M early launch, up 8%||2019-01-07|
|LOXO||$LLY $8B buyout TRK fusion drug VITRAKVI and other RET TRK mutation pipeline||2019-01-07|
|GNMX||AEVI-001 (oral non-stimulant pan selective activator/modulator of mGluRs.) miss on ADHD. 5mil cash left. Penny stock.||2019-01-06|
|SESN||Vicinium ADC anti-EpCAM+Pseudomonas Exotoxin A + PDL1 for high-grade non-muscle invasive bladder cancer (NMIBC). positive results but sell on news. Penny stock.||2019-01-06|
|VRCA||VP-102 [0.7% (w/v) Cantharidin] for molluscum contagiosum or common warts. Website boasting "innovation in its DNA". Not really an innovation.||2019-01-06|
|EPZM||EZH2 inhibitor tazemetostat seek accelerated approval for relapsed/refractory follicular lymphoma (FL). NDA 4Q19||2019-01-06|
|GILD||ASK1 (selonsertib), TGFb for NASH||2019-01-06|
|Poseida||IPO, CAR-T primarily of long-living early memory T cells, or TSCM cells||2019-01-06|
|UroGen||Liz Barrett (Novartis Oncology) Arie Belldegrun MD FACS - Chairman UGN-101 is (formerly known as MITOGEL™) (mitomycin) urothelial gel, 0.4%||2019-01-04|
|Immunocore||get Bahija Jallal president of the big MedImmune||2019-01-04|
|AAPL||Buffett average price so far ~$146-149 underwater||2019-01-03|
|NeuBase||Peptide nucleic acid (PNA) platform, better than $IONS||2019-01-03|
|BMY||$CELG $74B merger $50cash+1share $BMY for 1 share $CELG. Bad for $BGNE?||2019-01-03|
|ABUS||ABUS IPR challenge Heyes, Thompson, Janoff (Alnylam) depositions, 3-rounds long process up to July 2019||2019-01-01|
mesothelin-positive solid tumors, HLA-independent TCR tech, TCR2 Therapeutics TCR2
|DVAX||cGAS-STING is highly expressed in cancer tissues, negatively correlates negatively correlated with the infiltration of immune cells and prognosis||2018-12-31|
Ph3 PFS 4.7m vs 4.9m, numerically poorer, 12m OS same 74%, ORR 34.2% vs 31.5%
new Sanofi vaccine Vaxelis combines 6 diseases; but require 3 doses. a combo of old stuff. Not primary for Hep B
$ONCS sponsored research on Immunity show PD-1 requires DC/IL-12 to work$NKTR 214 deal came three month later with complete terms
|EGLT||delisted in September. Once a hot stock||2018-12-26|
|CAPR||LA-based Capricor to test CEO Linda Marbán’s husband, Eduardo Marbán, developed at Johns Hopkins. stem cell operators, repeated setbacks.||2018-12-26|
|ADMA||focus on immunodeficiency. Bivigam 10% Ig. relaunch got CRL. Was shutdown for CMC deficiency. -46%||2018-12-22|
|SPPI||poziotinib inhibits EGFR, HER2/neu, and Her 4 covalently, denied Breakthrough Therapy Designation (BTD) -39%||2018-12-22|
|DBVT||ViaSkin Peanut patch BLA withdrawn due to CMC and QC data insufficient. Now Aimmune $AIMT will be standard of care (patient will advocate nothing available) and $DBVT will lose this 1st mover advantage||2018-12-22|
|GTHX||Trilaciclib a first-in-class short-acting CDK4/6 inhibitor, failed 2/3 line SCLC, 13% ORR vs 23% placebo||2018-12-22|
|HSGX||Terminate NeoCart after FDA demanding additional trial down to $0.08 AH 2014 $11 IPO||2018-12-22|
|SPHS||Topsalysin, PSA-activated perforin, additional dose has no clincal benefit, 2013 IPO $5, now $0.85. But 1st dose has decent reponse. Designing Ph3||2018-12-22|
|SURF||CD47 SRF231 have low dose hematologic dose-limiting toxicities (DLTs) , no Ph1 expansion||2018-12-22|
|AGEN||est. 1994 $18, reverse split 1:6 2011, antibody platform, HSP cancer vaccine, AI discovery. Running 20 programs and 20+ trials, short on cash, deal with Gilead. Nice website.||2018-12-22|
|ADRO||$LLY deal $12M upfront ($620M) for cGAS-STING autoimmune and other inflammatory diseases||2018-12-22|
|FGEN||Fibrogen roxadustat approved in China for anemia in chronic kidney disease (CKD). expertise include: collagen HIF-PHI prolyl 4-hydroxylase enzymes, recombinant collagen synthesis, and extracellular matrix-associated processes and pathologies||2018-12-22|
|ACRS||Aclaris ESKATA (40% H2O2 Hydrogen Peroxide Pen) for age spots, seborrheic keratoses (SKs)||2018-12-22|
|BigPic||after fixing barchart and regression, gapindex have signaled trouble in early October 2018, churning throughout 2018 was also a warning sign, 2015 bear two legs for gapindex||2018-12-19|
|CHMA||after making a stellar +300% rise from $1.2 -> $4.87, now back to consolidation the last bottom? Data expected 3Q2019||2018-12-19|
lumateperone Ph3 for Agitation in Alzheimer discontinued. Main indication is Schizophrenia
|ACRX||added to Nasdaq Biotech Index ($IBB) effective 12/24||2018-12-18|
|ABUS||$ARWR ARC-520 was using its DPC EX1 dynamic polyconjugate delivery vehicle via IV infusion, not GalNac subQ||2018-12-15|
up 32% on patent "Differential diagnosis of ectopic cushing's syndrome"; Korlym, orphan drug approved 2012 for Cushing's. Also trying to venture GR antagonists into IO combo
licensed 2 more assets from UMass GM1 and GM2 gangliosidosis – also known as Tay-Sachs and Sandhoff diseases
Amgen $AMGN return rights of axalimogene filolisbac attenuated Listeria back to company after 2y and $78M
could not renegotiate debt, file bankruptcy. Management failure on costly launch and debt financing. See link to BloombergWas a PSIC candidate proposed by Zhou Bo for project 10 in Aug 2015. along with $GWPH $NBIX
valbenazine (Ingrezza, vesicular monoamine transporter 2 (VMAT2) inhibitor) fails Ph2b Tourette syndrome, approved for Tardive dyskinesia, another neurological disorder with involuntary movements
|IDRA||Tilsotolimod + anti-CTLA4 data update 32.4% ORR in PD-1 experienced patients. - 40%; dropped -86% more than $DVAX||2018-12-14|
index makes new low, biotech holds OK? fear of breaking downwards. Sector bullish percent indices at multi year low. Buffett's AAPL price $109
12-18-2018 $BPSPX $BPCOMPQ need to touch below 25; $RUT approaching 200wk MA.
12-19-2018 $RUT $TRAN touch 200wk MA; $BPSPX <25 $BPFINA <10 $BPHEAL <15 $BPINFO <20 $DVAX $ABUS holding strong while $XBI -4% to 200wk MA
12-20-2018 $BPSPX < 20 $BPCOMPQ <25 $BPFINA <8 $BPHEAL <10 $BPINFO <15 $VIX touch 30; big panic on option expiration day 12-21-2019. $CPC 1.82 all time high (previous 1.70: 2.26.2007, 1.69: 8.17.2015) MACD 20,200,12 sharp rise to 0.15
12-21-2018 $VIX >30 $WLSH approaching weekly 200MA $CPC MACD 0.172 current shiller PE is about 22~24 after forgetting 2008~2010 low earnings. If SPX normalized Shiller PE 16, it will be SPX1760. XBI, IBB. CNCR weekly RSI <30 first time in years, $CNCR lost almost 50%, IBB:XBI weekly spike
12-24-2018 $VIX >35 $WLSH below weekly 200MA, $CPC MACD 0.183 $BPCOMPQ <20, $BPSPX $BPINDU <15 $BPFINA $BPINDY $BPENER <5 $BPINFO $BPHEAL $BPDISC $BPMATE <10
12-26-2018 $DJI +1000, 5%, the biggest gain ever. Wait for second legs.
1-1-2019 CNBC positive outlook for 2019
1-4-2019 follow-through day FTD 周一中美谈崩 2nd leg down (1-30-2019: did not happen)
New CEO Barry Labinger from Biothera, Art Krieg now CSO. Biothera uses Imprime CGG (soluble 1,3/1,6 beta glucan from yeast) to combine anti-PD-1
Applied Genetic Technologies Corp fails Ph1/Ph2 rAAV2tYF-CB-hRS1 for X-linked retinoschisis with mutated RS1; $BIIB drops
|ACRX||continuous insider buying by multiple executives post-approval||2018-12-13|
Meets With FDA on Comparative Wear Study of Twirla® and Xulane: in healthy women with a Body Mass Index (BMI) less than 35 kg/m2 who will be randomized to either Twirla or Xulane for the first week and then switched to the patch not initially worn for the second week.
|CAR-T||cytokine storm can be inhibited through Adrenaline pathway. $GILD $CELG $NVS $KITE $JUNO||2018-12-13|
|ACRX||STATNews hit article released on investors' day. Pretty biased. Good investment. 越是唱衰越要买. Comments are sharp. Zalviso sales flat.||2018-12-11|
nelotanserin failed again on Lewy body dementia
LA company. SNA-120 (TrkA inhibitor with polymer) fails mild-to-moderate psoriasis
SPN-812 Viloxazine hydrochloride for ADHD, met endpts, size too small to compete. a morpholine derivative and is a selective norepinephrine reuptake inhibitor used as an antidepressant in some European countries,
another Ph2b failure ENCORE-PH trial for the treatment of NASH cirrhosis. Emericasan pan-caspase inhibitor and has antiapoptotic and antiinflammatory effects
tradipitant (NK-1R antagonist) Ph2 success in gastroparesis
rimegepant (Zydis orally dissolving tablet (ODT) formulation) Ph3 success. CGRP receptor antagonist
up 48% to $46.62 FDA will allow an accelerated approval pathway for voxelotor for sickle cell disease (SCD)
|MRNA||$600mil $23 midrange 20% more shares 7.5B cap largest biotech IPO in history||2018-12-06|
|ABUS||Brii Bio (Zhi Hong, ex-GSK) partnership with VBI, Vir (Alnylam RNAi) and Wuxi (bispecific Ab) for HBV cure||2018-12-06|
|BigPic||Huawei Wanzhou Meng arrested by Canada, market sell off after the interest rate inversion panic; but all my stock and XBI reversed and enter green mid-day, SPY reversed as well. Endpts: NYCEDC build space for life science ||2018-12-06|
|ABBV||ROVA-T may associate with lower survival||2018-12-05|
|Grail||poor HKEX IPO performance and volatility urged Grail to go for US only IPO, as well as Moderna $MRNA||2018-12-05|
off-the-shelf CART UCART19 needs prevent rejection by lymphodepletion plus immunosuppress 14/17 CR
$GILD Yescarta great survival but only $183mil revenue 9 month
|TSRO||$GSK bought at $75/share 5.1B 60% premium, compare to all time high $190, recent low of $23.41, PARP inhibitor Zejula and PD-1, TIM-3, LAG-3||2018-12-03|
best in class PD-1 antibody tislelizumab doubled CR rates (30% -> 60%) in treatment-resistant classical Hodgkin’s lymphoma. Western patients were typically pre-treated with Seattle Genetics’ Adcetris, which isn’t available in China.
$TNDM insulin pump
ALKS 3831 Olanzapine/samidorphan (antagonist of the μ-opioid receptor) for the treatment of schizophrenia Ph3 success showing less weight gain compared with olanzapine,
|HSGX||NeoCart BLA delayed||2018-12-01|
Amifampridine phosphate, a nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization, to improve LEMS patients whose nerves suffer from autoimmune disease.
see previous notes, recent IPO, antibody to treat bacteria disease failed, now reverse merger after only 1 year IPO
VX-659, tezacaftor and ivacaftor in patients with cystic fibrosis meet Ph3 success. patients with one F508del mutation and one minimal function mutation
MetAP2 pathway (metabolize fat) for type 2 diabetes on clinical hold for CV risk
$AQST PharmFilm Sympazan™ (clobazam) Oral Film approved but Erectile dysfunction CRLed
|ABUS||PPT: AB-506 data Q2 2019; AB-729 Ph1b start Q2 2019; to combine the two in Q2 2020; RNA destablizer AB-452 or backup postponed to Q2 2020. $ALNY: revenue light upon launch||2018-11-30|
|DVAX||$AZN AZD1419 Ph2a asthma fail, speculation was wrong||2018-11-30|
I/O R&D explode +67% in 2018; China #2; Opioid crisis continue with fentanyl; US life expectancy declines11.30.2018 CTLA-4 still dominates PD1 combo landscape, chemo etc.
$ABUS competitor, newly founded by Pharmasset SVP Abel De La Rosa, PhD and Idenix CMO Douglas Mayers, M.D, raised 25M Series A
VITRAKVI (larotrectinib) won approval for TRK fusion cancer regardless of cancer organ. share price drop on news
head-and-shoulder bottom (post to IV 11.28.2018); $ACRX head-and-shoulder bottom; $ABUS base on base
Opdivo+Yervoy fails NSCLC checkmate-451; VR475 nebulized budesonide fails severe uncontrolled asthma
|AIMT||Ph3 results published on NJEM||2018-11-21|
|BigPic||Big drop new low, $VIX third leg, Tech stocks drop big, $XLV $IBB hold well||2018-11-20|
Genevant promoted CSO Hansen to CEO
|THOR||Synthorx files IPO based on IL-2 lead $NKTR||2018-11-17|
|TSRO||looking for sale||2018-11-17|
|INFI||IPI-549 PI3K-gamma inhibitor + PD-1: 2 PR out of 44 patients in solid tumor||2018-11-17|
|EIDX||AG10 small molecule to stabilize TTR||2018-11-17|
|QURE||three patients average 31% expression FIX after AMT-061 for hemophilia B||2018-11-17|
licensed Ralinepag APD811 for $800m upfront
|DVAX||$AZN PD1+CTLA4 $HCM VEGF+PD1 both failed NSCLC. Good more DV281? or $AZN buyout if AZD1419 good?||2018-11-16|
|ABUS||$MRNA moderna S-1 no mention of LNP patent dispute||2018-11-15|
|DVAX||a patient cured melanoma posted on twitter using SD-101||2018-11-14|
|BigPic||people talks about shorting $XBI very bearish; moderna IPO signals IPO window closing?||2018-11-14|
|NKTR||$DVAX NKTR-214 may have some effect to boost T cell from exhaustion. See my post on IV||2018-11-12|
|TSRO||TSR-022 TIM3 + TSR-042 minimal effect; all the investors fall in love with their own stock, anything is encouraging :)||2018-11-10|
AAV-FVIII SB-525 for hemophilia A delayed
|NKTR||NKTR-214 53% ORR but CR improved to 24% #SITC $DVAX||2018-11-10|
|ADRO||STING has no effect as monotherapy #SITC as $MRK shows. $DVAX||2018-11-10|
|ABUS||Moderna $500 mil IPO $MRNA largest biotech IPO||2018-11-10|
|ACRX||12mil shares offering at $3.15 20% dilution||2018-11-09|
|DVAX||$ONCS phase IIb only 2 in 9 PR similar to SD-101, down 50% to penny stock, no longer a threat to $DVAX||2018-11-06|
|DVAX||$AZN sold older asthma drugs to other firm, reflecting its strong pipeline, including AZD1419||2018-11-06|
|ACRX||Zalviso revenue declines; people worry about Tmax vs IV morphine. Forgot about blood brain equilibrium||2018-11-06|
|DVAX||ER CC, 3 more CR after #ESMO as I predicted in June after #ASCO, may not >20% (11.13.2018)||2018-11-05|
XIPERE (formerly “suprachoroidal CLS-TA”) + Eylea combo no better than Eylea alone in retinal vein occlusion (‘RVO”) to focus on Uveitis, NDA filing by YE2018 down 63% to $2.07
3.5% QoQ growth, Nerlynx sales continue to disappoint
|CLVS||Rubraca PARP inhibitor sales disappoints, re $TSRO||2018-11-03|
|SBBP||$AEZS Macrilen sold to Novo Nordisk $145m, paid $24m||2018-11-03|
ARGX-110 cusatuzumab anti-CD70 for AML MDS 92%(11/12) ORR 75% (9/12) CR
brexanolone (SAGE-547) allosteric modulator of GABAA receptors AdCom 17-1
ALKS-5461 a combination drug formulation of buprenorphine and samidorphan for adjunctive treatment of major depressive disorder (MDD) failed 2 phase III trials but success 1 phase III trial. 2-21 AdCom vote
pegfilgrastim biosimilar candidate CHS-1701 (Udenyca) approved
approved close up 16%. No big jump. 52-week new high. FDA issued Gottlieb PR about opioid and DOD. see link for news. Media bashing FDA and $ACRX without telling the truth. Yahoo boards full of short term speculators. $TRVN CRL ask for more data
|AGRX||ER says cash enough to fund through wear study and into Q2 2019||2018-11-02|
|TRVN||rose +30% prior to PDUFA date, many people speculating an approval on StockTwits||2018-11-01|
|DVAX||patents about Heplisav-B licensed agreement reached with GSK and Merck ref1, ref2||2018-10-29|
|Sunli||not many companies have the expertise in process development of biologics like Amgen and Genentech. Even Pfizer or Merck may not match them.||2018-10-28|
UX007 (a highly purified, synthetic seven carbon fatty acid triglyceride) fails in patients with glucose transporter type-1 deficiency syndrome (Glut1 DS) experiencing disabling paroxysmal movement disorders Phase III
Entinostat HDAC inhibitor plus exemestane miss PFS endpts in breast cancer see previous failure notes
|SGYP||could not find a buyer even with a product Trulance||2018-10-27|
Clementia RARg agonist Palovarotene file NDA for FOP bone disease, BMP pathway regulation for rare bone disease
sitravatinib+Opdivo disappoints in NSCLC 16/56 28.6% ORR
|ADAP||Engineered SPEAR TCR MAGE-A10 MAGE-A4 no response at ESMO||2018-10-27|
|DVAX||46-47% PFS for Pembrolizumab; 85% SD-101 combo at ESMO; $MRK $BMY ready for deal derby (see link)||2018-10-26|
Oligo-mannurarate (marien derived Oligosaccharide) GV-971 meet Phase III endpts. targets Amyloid for clearance
|DVAX||10.22 ppt highlights: cellular biomarker data compare 2mg vs 8mg TME; phase III decision early 2019, neo-adjuvant I-SPY 2 breast cancer study initiated||2018-10-25|
$BMY reluctant to move NKTR-214 to Phase III, want randomized phase II trial
market bounce $BPHEAL down to 23.81 lowest in years
public advocates Dr. Raeford Brown Jr. and US senator Ed Markey urged FDA to reject Dsuvia
another big down day. IBB -6% XBI -7%. REGN to 200MA. BPI further down $BPFINA <20 $BPHEAL 33.33
|BigPic||-2205 net gap. index spike down, needle downward. $VIX didn't make new high. Sectors Bullish Percent Indices below 30||2018-10-23|
|ADRO||$MRK STING agonist 3-3-cGAMP (Invivogen) is indeed a bacteria product. Human cGAS makes 2-3-cGAMP, $ADRO c-di-GMP||2018-10-23|
|AZN||could it buyout $DVAX? had deal with Innate Pharma for anti-NKG2A monalizumab checkpoint inhibitor||2018-10-23|
|ADRO||Janssen terminated Listeria license and Aduro discontinued that program.||2018-10-22|
|MRK||STING agonist MK-1454 ESMO mediocre results 0% mono 24% combo in indications with little info on PD1 efficacy $ADRO -30%||2018-10-22|
|DCPH||DCC-2618 KIT PDGFRa dual inhibitor ORR dropped to 21% from 24% for GIST||2018-10-22|
|ECYT||acqurie by Novartis for $24/share and $2.1B||2018-10-22|
|MACK||MM-121 (seribantumab, anti-HER3) + docetaxel failed NSCLC futility||2018-10-22|
|REGN||dupilumab (anti-IL4R) approved (new indication) for asthma||2018-10-22|
|EYPT||extended release platforms for eye drug release||2018-10-22|
ESMO PD1 naive continue 70% response
|DVAX||HNSCC 30.4% ORR 8mg||2018-10-19|
DV-281 dose escalation is done, now Nivolumab is selected as anti-PD1 drug - good approach to have BMS drug on board as another potential SD-101 partner besides Merck. Enrollment number is extended from 80 to 167, all 5 trial site locations are published. 4 Cohorts (Squamous, PD-1 naive or not, EGFR/ALK mutation ) are specified.
|BigPic||MID cap and small caps dropped more than big cap, a big cap rally coming?||2018-10-16|
Serlopitant, NK1-R antagonist, failed cough after failing AD in April. to focus on pruritus (itching)
|AFMD||TandAbs novel NK or T cell engager. AFM11 on clinical hold due to SAE in 3 patients of NHL and ALL trial||2018-10-13|
|IMDZ||Cancer neoantigen and vaccine company. NY-ESO-1 based CMB305 failed Tecentriq combo in synovial sarcoma, focus on G100 intratumoral TLR4 agonist for NHL.||2018-10-13|
Nature Biotech: Setbacks shadow microRNA therapies in the clinic
|ALLO||Allogene, IPO big||2018-10-12|
Capsid: AL3778 withdrawn before recruiting, ABI-H0731 Ph2 started mid 2018
|CORI||Swiss billionaire Bertarelli purchase Corium $AGRX||2018-10-12|
|ACRX||AdCom 10-3 favorable votes||2018-10-12|
|TRVN||Trevena announced "successful" meeting with FDA when FDA didn't agree with it. AdCom negative (7-8). $ACRX||2018-10-11|
|DVAX||UCLA Ribas article and 13G show Healthcor 5.5% ownership||2018-10-11|
|AdCom||interesting novel companies I follow should have an AdCom, no Adcom no good. $DVAX 2nd CRL, $AGRX 2nd CRL (it was intended after adhesion issue solved for efficacy and safety), $ACRX 2nd CRL (an AdCom was required for all opioids)||2018-10-10|
|ACRX||briefing doc and question released, pre-market down to $1.62 due to false interpretation, open flat and then up, close +36%||2018-10-10|
|DVAX||AZD1419 Ph2a completed on 9.25.2018, ESMO PD-1 experienced abstract 1262P not so interesting||2018-10-10|
$ACRX competitor IV-PCA novel μ Receptor G Protein Pathway Selective (μ-GPS) Modulator, mediocre results in Phase 3, slightly better at safety in lowest dose, slightly better at onset time in higher doses. Down 64% with AdCom briefing doc
Today I finally realized that day-to-day follow-up and analysis of ABUS is pointless. I will go silence on this board, as if it matters :) I am ready to join Vivek as the long term investor (a.k.a bag holder). My average cost is less than $4. Wake me up when Sofia leaves. Pharmasset founded in 1998, IPO 2007.04, acquired 2011.11. Oncore founded 2012, Public in 2015.04
$NVS novel MS drug by binding S1p1 to prevent lymphocyte brain migration
|ABUS||-33+% ARB-1467 disappointing response, AB-452 RNA destabilizer delayed due to nonclinical safety findings, AB-506 capsid progress, new development chief from Janssen. My cost is lower than Roivant $5.28||2018-10-09|
|AGRX||completed FDRR nominally denied provided path forward to do a wear study comparing to Xulane, AdCom afterwards||2018-10-09|
|DVAX||6 month PFS for Pembrolizumab was 34-38% for Ph2 melanoma; 3 abstracts at ESMO||2018-10-08|
OMS721 MASP2 (mannan-binding lectin-associated serine protease-2) failed in renal disease
Tegsedi (inotersen) for ATTR approved
emicizumab (Hemlibra), a BITE antibody that mimics Factor VIII which lack patients with hemophilia A by bridge F9 F10
Thanks for sharing my post :) And thank fairvalueforyou for reminding the previous post, and most importantly for the inspiration. It is really an original way to look at clinical trial updates.
I shared that article to my college classmates. One of them is a fund manager in China. He was excited but was not sure that is a known or proven way to look at trials. Any previous examples. He was anxious that no analyst or even the company itself talks about AZD1419. It seems it is not important to them.All I can say is, look at the logic. Make your own judgement. Being ignored is a blessing in investment.
deal with $JNJ 175M upfront $75M equity @$23. $ARWR just dumped ARO-HBV to focus on other pipeline. JNJ will have worldwide license to develop and market it. Good luck to JNJ.
|DVAX||came down from $24 to $10 to close AdCom gap in July 2017 despite approval, SD-101 early results||2018-10-04|
PlainView respond to company's response. Peg-IL2 is not going to turn tumor hot.
|ABUS||extra-hepatic LNP targeting screening method by Scripps||2018-10-03|
Replicor drive 70% (28/40) patients < 1IU/ml, 60% (24/40) non-detectable. AB-1467 can only do 5/12 <50IU/ml
mRNA vaccination with charge-altering releasable transporters cures established tumors; not LNP $ABUS
29% flash crash when XBI down 2% to 200MA.
In a 2013 interview with Nature, Allison described the resistance he met when he first tried to get pharmaceutical companies interested. “It was very frustrating,” he said. “They said, ‘It may work in mice, but it’ll never work in people’. The concept was new and it was so unusual.” Allison marched from company to company in search of one that would take on the project. Ultimately, Bristol-Myers Squibb of New York City was the one to push ipilimumab over the finishing line.
|CHMA||Completed enrollment early, now expect OPTIMAL results Q3 2019||2018-10-01|
Cantor talk 24:46 $AZN anticipate AZD1419 high level results by year end 2018. Completed as planned.
goes to James P. Allison and Tasuku Honjo “for their discovery of cancer therapy by inhibition of negative immune regulation.”
Ex-Kerrisdale analyst Aaron Wedlund short attack on NKTR-214: ‘It doesn’t work’. 2% peak conc. <1% activity
Dr. Woodcock is acting director of OND and director of CDER; OMPT is vacant. If no favored opinion from Woodcock in the coming weeks, it may take many months and Dr. Gottlieb to get a final call on Twirla
etokimab (anti-IL33) show 8-11% FEV1 lung function improvement over placebo
topical ocular reproxalap for dry eye disease. RASP inhibitor to reduce aldehyde and inflammation. Hsp90 inhibitor
ublituximab (anti-CD20) plus umbralisib (PI3Kd inhibitor) combo for CLL could not be analyzed for ORR, to focus on PFS
Imetelstat: first-in-class telomerase inhibitor. Rights returned by $JNJ surprised from expectation
Vascepa (icosapent ethyl) pure EPA Omega-3 derivative for Cardiovascular. was approved in 2012 for limited indication, now reported positive for broader indication up 444%
The Incredible Expanding Universe of Biotech Stocks: IPO outpaced market, more public companies, higher valuation
|DVAX||actual enrollment larger than assignment, then split between arms?||2018-09-27|
|DVAX||at least two abstract at ESMO, melanoma and HNSCC||2018-09-26|
Selective Androgen Receptor Modulator (SARM) enobosarm in post-menopausal women with stress urinary incontinence (SUI) failed Ph2, down 92%
up 87% success on Ph2 NAFLD $MDGL competitor same MOA,
Engineered Toxin Bodies (ETBs) platform Forced Internalization, enzymatic and permanent ribosome inactivation, De-Immunized Toxin Scaffold, Payload Delivery? RNAi? deal with Takeda for CD38-ETB
FDA safety inspection came positive: no new or unexpected safety findings
|AGRX||add 3000 shares ($1k)@$0.3413 (3000*$0.33+penny stock fees), island reversal; Great decision (2018.10.12)||2018-09-25|
|ABUS||IPR instituted Patent Inter Partes Review ||2018-09-15|
ELAD System is an extracorporeal human allogeneic cellular liver therapy failed to improve survival in Ph3. had IPO problem in 2013, tried again in 2014, failed Ph3 in alcohol-induced liver decompensation in 2015
met just 1of2 co-primary endpoints in Ph3 of 1404, imaging agent to visualize prostate cancer
$GILD partner Phase 3 filgotinib (JAK1) in adults with moderately-to-severely active rheumatoid arthritis success
pivotal trial required of AT-GAA for Pompe disease, current data insufficient.
|ACOR||4 Ampyra patents invalidated; FDA extended PDUFA of Inbrija 3 months to review newly submitted CMC info||2018-09-15|
|GILD||Precision Bio deal to use its ARCUS homing endonuclease to gene-editing HBV; need LNP to deliver? to boost IPO?||2018-09-12|
|DVAX||new 52-week low, check insider trading, no severe selling||2018-09-12|
old news article "recently enacted FDA Opioid Action Plan which requires the FDA to convene an expert independent advisory committee prior to NDA approval of any new opioid drug [the only exception is for new opioid drugs that contain abuse-deterrent properties]"
Dirk's blog on recent success from $ARWR $DRNA; $DRNA LNP DCR-PH1 not enough knockdown
AdCom 10.12 only with Anesthetic and Analgesic Drug Products, no Drug Safety and Risk Management joint meeting.
|SGMO||did it work in MPS II? SA article with 4 hypotheses||2018-09-10|
|EDIT||$CRSP $NTLA Caribou Federal Circuits ruling in favor of $EDIT||2018-09-10|
|Eureka||CAR-T for AFP+ liver cancer worked in 6 patients, 3 died though due to non-drug related complications.||2018-09-10|
|AGRX||pop 100% AH, no PR.||2018-09-10|
$IONS volanesorsen for familial chylomicronemia syndrome on safety issue
All have its own BioLog entry except for $BHC
|HSGX||cell therapy for cartilage miss Ph3. Lots of hand waving on website||2018-09-08|
positive interim data QR-110 for Leber’s congenital amaurosis 10 (LCA10). ADAR RNA editing.
first human gene editing data as MPS II therapy, GAGs (substrate) down but could not detect serum IDS enzyme, market question whether therapy worked. I think it did, down due to profit taking and sell on news
$AMGN partnered anti-TSLP received FDA BTD; another news
EyeGate® Iontophoresis Delivery System; CMHA-S platform based on hyaluronic acid (HA), a naturally occurring polymer. Failed anterior uveitis did not demonstrate non-inferiority to the prednisolone acetate ophthalmic solution control
similar to $EGRX formulation company. IV meloxicam for Acute post operative pain CRLed in May 2018 due to "analgesic effect does not meet the expectations of the FDA", now resubmitting "will incorporate revised language relating to the product label and, additional information relating to extractable and leachable items.", non-opioid treatment option, not a threat to $ACRX
license deal Ph3 dry powder formulation treprostinil, for pulmonary arterial hypertension, to $UTHR, $45M upfront
announce ARO-HBV results, decent results, has nuc naive and eAg+, no patient details. pop +58%, cash low, to offer？
Checkmate to collaborate with Pfizer/Merck KGaA
|NKTR||fill the gap rally seems setting up another gap down after reaching 200MA||2018-09-04|
Topsalysin, a first-in-class, pore-forming protein, only activated by actitve PSA enzyme found in prostate cancer
Santa Monica based Narcan (naloxone HCl) Nasal Spray for the emergency treatment of opioid overdose
|AFMD||NK cell based immunotherapy, deal with Genentech, up 247%||2018-09-02|
|DVAX||Ribas and Levy, respectively, published stories of Ph1b Melanoma and Lymphoma SD-101 on Cancer Discovery (IF: 24)||2018-08-28|
FDA rejects volanesorsen for familial chylomicronemia syndrome on safety issue #CRL
|ALNY||relief rally 16% on Tafamidis ATTR-CM soso data released. Tafamidis already approved for FAP. Will compete. ||2018-08-27|
|MGEN||miRagen was still private in this RNA stock summary article; went public with $SGNL reverse merger; completed Feb 2017 with $40M private offering; 2018.02 offering $35M @$5.5. Reminded by Yu-Lin Su at ISEH. Now the leader.||2018-08-26|
Inveltys (corticosteroid) approved for post-operative inflammation and pain post ocular surgery. No price move.
ulipristal acetate (Esmya) CRL due to post-marketing safety report outside of US
|MNK||Stannsoporfin CRL received post 3-21 AdCom||2018-08-26|
Up 29% $JNJ advertise for Strategic Pricing Manager for Imbruvica and Imetelstat. due whether continue Imetelstat program
Cologuard non-invasive stool DNA screening test for colorectal cancer; co-promote deal with $PFE
Hit by surprise setback, AstraZeneca scrambles to explain why its two-in-one COPD inhaler was beaten by GSK rival
|BPMC||ISEH Nick Lydon talk, all three Lasker winners for Gleevac are scientific founders of $BPMC||2018-08-23|
|DVAX||mologen subQ CpG lefitolimod failed as SCLC monotherapy after PR for platinium chemo. show MOA.||2018-08-21|
|DVAX||fairvalueforyou pointed that CYT003 failed 5months after enrollment complete (7 week treatment +12 week follow up), planed for 9 months follow-up. The trial has an add-on design, not withdrawal. patients has ICS w./w.o. LABA||2018-08-19|
$TEVA Epipen generic approved. commercial launch of $ADMP at the discretion Novartis' Sandoz. Poor stock
Lenvima (lenvatinib) kinase inhibitor for hepatocellular carcinoma (HCC).
Kalydeco (ivacaftor) CFTR potentiator for cystic fibrosis. extended to infants.
|DVAX||$IDRA to focus its resources on TLR9 after merger fail, give up rare disease, uses 8mg||2018-08-16|
|ABUS||Pfizer invest in BioNTech's mRNA vaccine while Genevant deal was about rare disease and oncology||2018-08-15|
wrote about AZD1419 trial withdrawal speculation, no impact on twitter
Moderna’s Billions: Will Building Big Before an IPO Pay Off?
|DVAX||asthma loss of control references: 1, 2, 3, 4, 5||2018-08-13|
|ALNY||sell on approval news due to restricted label? Now I know why they raised before news: 1) give investors hope to move up, they won't be willing to buy if already hyped up 2) potential risk if results not good. 3) give old investors an edge.||2018-08-13|
CSPR tout 60% quadruple KO and CART but no off-target mention; file LNP patent application; against $ABUS
|ABUS||read Dirk RNAi analyst blog about RGLS fiasco, then other HBV RNAi companies, including ABUS, DRNA (preclinical), ARWR (long term tox data pending)||2018-08-12|
|DVAX||read bashers on SA, doubting Heplisav B market potential, post marketing plan, SD-101 no partner, loan term milestones, CDC order||2018-08-12|
|modality||Celebrating new therapeutic modalities by Robert Plenge CWRU MD/PhD||2018-08-12|
Palmer (as well as CEO, CFO) bought a total of 37,000 (total 57,300) shares at $2.75-2.89 open market
Cleaning up the hygiene hypothesis PNAS 2017 Time to abandon the hygiene hypothesis: new persp. on allergic disease, the human microbiome, infectious disease prevention and the role of targeted hygiene Perspect Public Health $DVAX
acquired Macrilen from $AEZS; RECORLEV (levoketoconazole) for Endogenous Cushing's syndrome Ph3 success
Is modern medicine weakening the human race genetically?
INOpulse, inhaled nitric oxide to respiratory system in pulses, failed pulmonary arterial hypertension (PAH)
GABAA receptor agonist for rare Angelman syndrome. Neurology drug, efficacy doubtful. No current treatment.
terminated its Ph2a trial of gemcabene in pediatric patients with non-alcoholic fatty liver disease (NAFLD) -45%
|ACRX||$PTIE Remoxy CRL follow previous 3-14 adcom vote||2018-08-11|
Annovera (Segesterone Acetate/EE Vaginal Ring) approved after previous vaginal pain CRL reversal. no SP change. $AGRX
Giapreza angiotensin II for IV early sales fall short of expectation?
|ENDP||down >90% following aggressive acquisitions and Opana ER withdrawal, turn around coming? Not interested||2018-08-11|
SPK-8011 for Hemophilia A sees immune response, variable outcome, ALT flare, push for PhIII. LNP better?
sales driven by Acthar Gel (the price hiked old product of QuestCor QCOR, bought out by MNK in 2014 for 5.6B vs 2.6B now)
|ABUS||$SGMO IV AAV v. LNP discussion ||2018-08-11|
PTG-100 discontinued due to CRO error. Raise $22M To revive. α4β7 integrin antagonist peptide for ulcerative colitis
$AZN search clinicaltrials.gov for "astrazeneca | Recruiting, Active, not recruiting Studies | Asthma | Phase 2, 3" found 10 studies: AZD1419, anti-IL5R, anti-TSLP, and PT001 (Glycopyrrolate inhaled). only 1419 is immunomodulator.
search 'asthma "withdrawal design"', found only one study: AZD1419. Company pipeline
|CHMA||+40% $1.25 to $1.75 on >10X volume spike after Q2 updates and making all time low.||2018-08-10|
|NKTR||$IONS both see technical recovery, potential uptrend again? NKTR moving forward with 214 216 PhIII planned||2018-08-09|
|ALNY||7 death in patisiran arm all cardiac death, not drug related||2018-08-08|
|ACRX||offering option exercised in full||2018-08-08|
|DVAX||ER CC transcripts talked about detailed Heplisav stories, CDC, prison, large provider, top 10 account, takes time, when, not if. Partnership wants to see more patients and FDA discussion.||2018-08-06|
AZEDRA® (iobenguane I 131) for rare tumor radioactive therapy for rare tumors
EZH2 inhibitor tazemetostat failed another indication DLBCL
|NBIX||Ingrezza exceed estimates again||2018-08-04|
Blueprint, company focus on kinases. avapritinib Kit PDGFRa inhibitor for GIST to submit NDA
|MNKD||continue to fail commercial decline 98% from high||2018-08-04|
|TSRO||PARP inhibitor continue to miss revenue, price decline almost 90% from high||2018-08-04|
|ACRX||CC talked about AdCom topics REMS , IV morphine shortage accelerating P&T committee approval, commercial plan||2018-08-03|
|ABUS||Yesterday breakout was fake, down -20% after ER. CC talked about trial design, MOAs and Combo||2018-08-03|
break out sideway bullish flag. People who quit to "avoid the down again" or lock in "profit" miss the bus
|IDRA||Reverse split 1:8 ||2018-08-01|
|ACRX||join anesthesia and risk management AdCom meeting Aug 3 announce only 3 weeks earlier on July 11||2018-08-01|
Small cap. CRL on buprenorphine sublingual spray as a treatment for moderate-to-severe acute pain
nano cap, Tonmya inhibits serotonin2a R, alpha-1 adrenergic receptor, histamine-1 receptor. Failed PTSD PhIII
a nano cap company working on Neutrolin a non-antibiotic anti-infective developed as a preventative solution to decrease the threat of infection and blood clots (thrombosis), thereby keeping central venous catheters (CVCs) operating safely and efficiently. PhIII Interim analysis achieved endpoints.
TORC1 inhibitor RTB-101 show positive PhIIb results in elderly patients at risk of morbidity and mortality associated with respiratory tract infections (RTIs) despite failed combo with approved mTOR inhibitor everolimus. "less TORC1 inhibition works better than more TORC1 inhibition"
|ACOR||sole MS drug Ampyra patent expire. Attempt to block generic entry fails||2018-07-28|
|GSK||Nucala Mepolizumab anti-IL5 failed AdCom 3-16 for COPD||2018-07-28|
|BIIB||BAN2401 results has catch, APOe4 imbalance. Company pushing for accelerated approval||2018-07-28|
Positive PhII Data for Bardoxolone Methyl in CKD Caused by Alport Syndrome and ADPKD $RGLS competitor
|CHMA||MPowered trial complete enrollment expect data Early 2020 for EU submission||2018-07-26|
|AGRX||dispute denied at ODEIII, CRL was by DBRUP, going to Office of New Drugs, next step CDER/OMPT, then Commissioner. Glad I didn't add more||2018-07-24|
|ABUS||LNP vs GalNac MOA: fast and transient vs slow and stable. Combo's best. Competitor has no option.||2018-07-23|
acquired AAV DNA gene therapy company Agilis (National Taiwan University ) for CNS disease Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency $50 + $150 stock
Flt3 JAK2 dual inhibitor Pacritinib FDA requires PhIII trial
expect CHMP positive opinion for pegfilgrastim biosimilar candidate CHS-1701
|AVEO||Tivozanib delayed for 1Q to Q4 18||2018-07-21|
Dolaflexin (polymer Vedotin (auristatin)) ADC targeting Her2 or NaPi2b. Clinical hold. Jun 2017 IPO
|ABUS||#TA chart either a double top or about to break out ||2018-07-20|
|ACRX||early August AdCom no $ACRX, now most like mid September to early October||2018-07-19|
|DVAX||shorts waving VBIV, may come 2020, 3 dose, that's why no partner? DVAX future is IO and Immune-modulatory TLR||2018-07-18|
|DVAX||Jimmy Cramer pumped Dynavax again, given no reason.||2018-07-17|
|ABUS||look at minute chart, does not see a short term top $ACRX strong base on base $DVAX $AGRX neutral||2018-07-15|
|Roivant||Urovant goes IPO raise $150M $UROV||2018-07-15|
axalimogene filolisbac attenuated Listeria with antigen-adjuvant fusion protein for Immuno-oncology FDA lifted clinical hold
Pixuvri Rituximab combo fail. Pixuvri is anthracyclines without cardiotoxicity
Luspatercept for RBC maturation, success with b-thalassemia pts after MDS 2 weeks ago. No significant price change.
BioCryst $BCRX shareholders rejected merger offer. IMO-2125 now called tilsotolimod
ZX-008 Fenfluramine PhIII success. reduction in monthly convulsive seizures was 62.7%
|Timing||missing best and worst 25 days beats buy-and-hold, but doable or not? Focus on Buffett rules and the company||2018-07-12|
|ABUS||lots of old TKMR era IV holders sold to the rally or even completely quit to "avoid the down again" or lock in "profit".||2018-07-12|
|ACRX||offering priced $2.75 raised $20mil. Close -13% $2.95 purpose?: to buy time for buyout||2018-07-12|
|GWPH||approved on 6.25.2018||2018-07-11|
|ABUS||short interests rose from 0.8mil to 2.8mil at Jun29 cut off vs Jun15. at price $6.35-7.30||2018-07-11|
Raise money. Perhaps no EU partnership. Company is more attractive to a larger company with full global rights for buyout.
|ABUS||Break above $10, I (ego as well) thought it to retreat from $9.4 since rose too much already. Never predict short term||2018-07-11|
watch Roivant day reply.
license from Benitec BB-301 for Treatment of Oculopharyngeal Muscular Dystrophy and Broad Platform Collaboration
|DVAX||DV281 preclinical study published at Cancer Research. June 2018 PPT presentation explicitly show combo without anti PD-1||2018-07-08|
|RGLS||CMO was fired due to restructuring||2018-07-08|
|ACRX||Opioid crisis is the hottest healthcare crisis. Opportunity for ACRX. 10.6mil options 51mil shares outstanding as of 1Q18. Discussion on Yahoo about EU partnership scenarios 1. partner in 100M range 2. no partner and sell whole later to BP. If they do, watch for who they partner with, Grunenthal or BP. They have repeated said Grunenthal has no advantage.||2018-07-08|
|ADMP||Symjepi, Mylan Epipen competitor, epinephrine PFS, sign deal w. Sandoz. Still low MCap. lots of CRLs, mediocre long time||2018-07-07|
|DVAX||AZD1419 PhIIa updated a 4-day diff for completion. ||2018-07-06|
BAN2401, an anti-amyloid beta protofibril antibody for early Alzheimer's disease, PhII results significant. +20%
rise above new high and weekly 200MA, gap up on big volume 7.5.2018, gap closed next day 7.6.2018 due to downgrade by Madhu Kumar@Riley the same buy @Chardan. Close green with new high
|RGLS||restructure: pause Alport to discuss Sanofi w. early results, prioritize HBV, pause ADPKD due to mouse toxicity, 60% layoff, down -48% AH small volume. close -52% next day. target 0.45 reached. Will go lower. Reverse split inevitable.||2018-07-05|
Found WHO/NIH PPT in DNA and mRNA vaccines. CureVac, GSK uses LNP. Gritstone/ALNY/SGMO/CRSP/NTLA/Generation Bio/Moderna/RGLS/CureVac/GSK/TranslateBio
news article at SF Business Times wrote about Pentagon threatened to start its own drug-approval process. Also on how DoD got involved with AcelRx after Zalviso presentation. Opioid crisis: both abusing Px and shortage in hospital.
preliminary response posted. Argument is strong and clear with lots of figures to compare the '069 and '127 patents.
|ACRX||Adcom maybe early August mid September. announce 1m prior. Different AdCom has different logistics. See DVAX||2018-07-02|
down 96% since hype of first drug Onivyde approval, 1.9m improvement, commercial failure, restructure, now new PhII failure bi-specific anti-IGF-1R/ERBB3 antibody for pancreatic cancer
|AKAO||FDA approved one and CRLed another indication, just as AdCom voted.||2018-06-30|
Aquinox Rosiptor activator SHIP1 to regulate PI3K. PhIII failure interstitial cystitis/bladder pain syndrome. 2015 IPO down big. Just signed $25m with Astellas
|GBT||Voxelotor binds to hemoglobin to prevent RBC sickling. 2015 IPO. 1 drug $2B. Pause trial, trial detail concerning. asking for accelerated approval. $BLUE competitor ||2018-06-30|
Oxford spinout. No focus: antibiotic + DMD utrophin mod, which just failed. Sincere letter to community. 2016 IPO down big
|ASNS||use antibody to treat bacteria disease. ASN100 (2 mAbs) binds to 6 toxins of S. aureus, but trial fail. Recent 2017.12 IPO down big||2018-06-30|
|GEMP||first in class to lower VLDL and inhibit cholesterol and triglyceride. PhIIb Success for statin failed pts. 2016 IPO, micro cap, competition?||2018-06-30|
Acceleron in 20-50 range forever. First in class TGF-b platform. Lead Luspatercept for RBC maturation, success with MDS pts
|DVAX||assembles stellar scientific advisory board for "immuno-oncology and new vaccine". E. John Wherry is Parker ICI co-director. Idera, Nektar, Oncosec do not have. Five Prime (Pardoll), Surface (Wherry), Gritstone do.||2018-06-28|
|ABUS||about to break above weekly 200MA, first time since 2015, showing strong relative strength||2018-06-27|
EMA approval. No partnership news. stock pop pre-market, open flat, sold on news -3.9% (XBI -3.2%)$PTIE Remoxy opioid gel got 3-14 AdCom vote. Fear from opioid crisis still haunts $ACRX. Someone at Yahoo board had 32y Emergency medicine exp. really positive about Dsuvia
reorganize layoff and shift people to subsidiaries. $ABUS William Symonds become CEO of new Altavant on pulmonary arterial hypertension
Factor IX protease, CB 2679d aka ISU304, noted the presence of a neutralizing antibodies in patients' blood.
PhI of risdiplam RG7916 modifying the splicing of the SMN2 to generate more full-length SMN mRNA in SMA patients
OBE2109, a gonadotropin-releasing hormone (GnRH) receptor antagonist with less bone loss side effect
Flt3-ITD inhibitor quizartinib to file NDA for AML
|Kallyope||deal with Novo to discovery gut-brain axis on metabolism drugs.||2018-06-25|
|DVAX||presented at diabetes meeting on post hoc analysis of diabetic cohort ~90% vs 60%||2018-06-25|
|ACRX||CHMP April -> EMSA approval PR date 6.23-7.7 mostly 6.27,28,...30.||2018-06-24|
|SRPT||early success in DMD gene therapy||2018-06-20|
|ACRX||New corporate slides highlight the other opioid crisis - opioid shortage due to manufacture problem. Also mentioned in CC. Zalviso EU sales new high in March||2018-06-18|
canakinumab anti-IL1b reduce gout besides previously announced cardio
|VIIV||HIV two drug regime to replace Gilead 3 drug regime||2018-06-16|
FDA Regenerative Medicine Advanced Therapy, or RMAT, for Phase III drug NSR-REP1for choroideremia, a rare genetic condition that causes progressive vision loss, by correcting mutations in the CHM gene.
Top Celgene exec pins the blame for ozanimod fiasco on the Receptos team — acquired 3 years ago. ex-CEO Faheem Hasnain does not think so
FDA, like software, having hospitals buy licenses to antibiotics instead of reimbursing on a per-use basis. #pricing
CRL after letter of deficiencies: human factors studies, device modifications, and potentially a clinical validation study
|VTVT||part B confirmed failure. Still pinning hope on subgroup analysis||2018-06-16|
Healthcare MDGL MRTX VKTX ECYT CERC TRXC QURE ARWR CASI took 6m-2y to form a flat base
Surged 151% on mixed results. Aramchol first in class, orally active, liver targeted SCD–1 modulator with a dual mode of action on liver fibrosis, down regulation of steatosis and a direct effect on Hepatic Stellate Cells (HSC’s), the human collagen producing cells.
|MDGL||exploring sale of company ||2018-06-16|
|SAGE||FDA allows only One pivotal trial for SAGE-217 for MDD and PPD; $575M ($90M up) japan deal||2018-06-16|
Parker Institute brings together the world’s brightest minds to push the boundaries in cancer immunotherapy research
|CHMA||OPTIMAL trial 50% randomized. On track to complete enrollment by YE2018 and top-line data Q4 2019||2018-06-14|
|ABUS||Added to Russell 3000. Volume pickup in tight trades||2018-06-14|
Checkmate AACR report on turning cold tumor into hot. Historical opinions.
|DVAX||talked to poster at I3T on PD-1 neoadjuvant therapy||2018-06-13|
licensed rights to OXB-102 (AXO-Lenti-PD), a gene therapy for Parkinson’s disease. up 150% to $4.80.
DCC-2618 is a KIT and PDGFRα inhibitor that blocks initiating KIT mutations in exons 9, 11, 13, 14, 17, and 18, known to be present in GIST patients, and the D816V exon 17 mutation known to be present in ASM patients. DCC-2618 inhibits PDGFRα mutations in exon 18, including the D842V mutation that drives a subset of GIST.
|GILD||deal with Hookipa on HIV and HBV, using LCMV vector to delivery non-replicating strong immune response||2018-06-07|
submitted a formal dispute resolution request (FDRR) 2 month (1m meeting 1m decision) turn over, workforce reduction, cash to 2Q2019
|ABUS||New CFO was Incyte's original CFO from 2003-2014||2018-06-07|
Why 2mg works better? Higher dose CpG does not mean higher IFN response. High dose actually inhibits IFN response.
subgroup analysis “appears to” yet consistently show 2mgx4 works much better in weaker patients: older, ECOG=1, LDH hi, and later stages, suggesting multi sites dosing has a better chance for a weakened immune system.
CRs happened at 2nd, 4th or 5th scans. So 13 patients who had only 1 or 2 scans will eventually have 2~3 more CRs. That will bring CR rates to 23~27%
|NKTR||Flemming two-stage design. 2nd stage data underwhelm||2018-06-04|
Merck signals it will be more cautious with combo trials after Incyte failure (needs single-agent activity for both drugs), but AstraZeneca says risk still worth taking
|TXMD||FDA reverse CRL under new commissioner Gottlieb Politics?||2018-06-02|
|SNDX||Entinostat HDAC inhibitor to combine with $NKTR NKTR-214 IL-2 receptor||2018-06-02|
baricitinib (Olumiant) approved 2mg; 4mg limited to TNF resistant ones $INCY
sc2Wear® Infusor, subcutaneous delivery of infused therapies. FDA issue letter of deficiencies
|MDGL||achieved PhII liver biopsy endpoint, $16 -> $280 in 9 months $VKTX also soar same MOA||2018-06-02|
|CLSD||market overreacted to new results. Intraocular pressure IOP is fine if not chronic. RVO results was great.||2018-06-02|
|analyst event||has no predictive power. ASCO 2015 VBLT VSTM now both bursted; NKTR 2017 success, BGNE noe immediate change but now big; Jounce hosting one 2018 despite fail. $IDRA, $NKTR, $DVAX||2018-06-01|
|Antibody||broad patent no longer allowed; need to be specific. Retroactive||2018-06-01|
|ABUS||New USPTO chief Andrei Lancu may favor patent owner||2018-06-01|
|CLSD||phase II numerically worse than Eylea, but not significant. I think overreact since CLSD require less dosing.||2018-05-31|
|AZN||failed another Fasenra COPD expansion. really need better respiratory franchise.||2018-05-31|
|ABUS||Moderna challenge, preliminary response due 6.15, board decision due 9.15||2018-05-30|
|BioLog||First period after launch 3.10 - 5.18.2018 daily record; take too much time too much noise (Taleb Black Swan information and knowledge) Go back to weekly top news and BopPharmaCatalyst||2018-05-29|
|DVAX||200k share sold by multiple officers in march 2018||2018-05-26|
|13F||nothing significant; AGRX increased; QVT sold||2018-05-26|
|ACRX||NDA accepted PDUFA 11.3.2018 1 year delay||2018-05-24|
|ACRX||Three Arch's 9mil shares reached term; acquired by Leerink partners in private transaction. Confidence||2018-05-23|
|DVAX||$MRK NSCLC chemo-PD1 combo success, raise the bar for DV-281?||2018-05-23|
|DVAX||TLR7 viral IFN induction is impaired in Asthma. TLR9 same fate? IFN reverse Th2 in human||2018-05-22|
#ASCO18 SD-101 has much less AEs than lenvatinib. Chemo or cetuximab + PD-1 combo results not available for preview.
#ASCO18 HNSCC PD-1 combo peers: T-Vec 16.7% (6/36) lenvatinib 36.4% (8/22) $DVAX SD-101 33% (6/18; AACR)
AZD1419 first-in-human study published. Previous 1018 publication 2006
|SNDX||Entinostat HDAC inhibitor poor results post hoc in monocytes high patients||2018-05-18|
|AGRX||Type A meeting minutes requested reformulation, bioequivalence, new phIII trial. Decide to appeal. 80% accept 16% granted||2018-05-18|
|AMGN||first-in-class Aimovig (erenumab) $NVS anti-CGRPR antibody approved by FDA $6,900/year||2018-05-17|
|NVO||stem cell therapy to cure diabetes||2018-05-17|
FDA approves first non-opioid to treat withdrawal symptoms in adults
$LOXO RET-fusion inhibitor biggest winner competitor $BPMC not so
|DVAX||Sell off after ASCO abstract release 60% ORR Gap close. Gap fill order filled 157 shares $2.5k @$16.50||2018-05-17|
|PFE||Epogen biosimilar approved (Retacrit) after 3 years of struggle||2018-05-16|
funding from Ge Li for CPMPs — cell penetrating miniproteins. a structural “brace” that promises to make their polypeptides effective against tough targets like β-catenin.
CMC complete response letter for DWP-450 (prabotulinumtoxinA) Botox rival
|DVAX||ASCO abstract release 60% ORR per protocol 15/25, another 5 non-evaluable. NKTR-214 52% per protocol ||2018-05-16|
|ACRX||Breakout above 200ma on big volume and break even on my investment||2018-05-15|
new tech in genetic sequencing machine learning algorithm precision meds for cancer and autoimmune disease.
$AMGN $NVS Lilly's galcanezumab fell behind erenumab
murepavadin against Pseudomonas aeruginosa and anti-CXCR4 drug balixafortide oncology
|Xenikos||T-Guard targeting CD3 and CD7 for GVHD||2018-05-15|
UK-based CellCentric’s CCS1477 p300/CBP inhibitor through Phase IIb in prostate cancer
PI3K inhibitor for a common non-Hodgkin lymphoma
|LLY||bought back Aurora kinase A inhibitor it shed in 2016||2018-05-14|
David Liu, now-serial entrepreneur Feng Zhang, and J Keith Joung using CRISPR to rewrite bases not cut
FDA Agreement to Redefine Certain Secondary Endpoints in CHIASMA OPTIMAL PhIII trial
|SURF||CD47 overexpress on tumor cells to prevent macrophage phagocytosis||2018-05-14|
$PFE automatic synthesis 默沙东 辉瑞 高通量自动化反应筛选的"军备竞赛"
|DVAX||brief <10% sell off on ER. Strong volume gap up rise after that sell off. So my judgement to buy was right: 1. weekly 200MA resistence 2. $16 level resistence. Fearing ER sell off was controlled.||2018-05-13|
|REGN||$GILD $CELG $BIIB $INCY all experience deep correction to low P/E. Bottom and trend reversal may come in 2019||2018-05-13|
|IONS||$AKCA won AdCom 12-8 despite safety concern||2018-05-11|
|CLDX||cut CDX-014 anti-TIM-1 ADC and CDX-1401 NY-ESO-1 DC vaccine. Focus on CDX-1140 anti-CD40 and CDX-3379 anti-ErbB3||2018-05-11|
Push benralizumab antiIL5R failed in a COPD trial. $GSK Nucala Mepolizumab was first-in-class
|Biotech||Trump speak on drug pricing, lots of promise, no tough measure. Endpts.com opinion on high healthcare cost||2018-05-11|
implantable, credit card-sized device containing these beta cells that would do the work of a healthy pancreas
post hoc analysis of the failed first round of Phase III data
Eight years after Eli Lilly dumped it, Provention Bio bring teplizumab a IPO to back a PhIII diabetic comeback
Acquired $ARMO for pegilodecakin, a PEGylated IL-10 immuno-oncology
new microbiome IPO "monoclonal microbials"
Ex-Receptos CTO Marcus Boehm found new startup for Mas related GPCR
|Lodo||Metagenomics from soil bacteria for drug discovery||2018-05-10|
Add 1493 shares ($3.7k)@2.50 Abandon LABU (time decay is annoying)
|ABUS||Add 655 shares ($4k)@$6.10 Abandon LABU (time decay is annoying)||2018-05-10|
|DVAX||Add 138 shares ($2.3k)@16.60 pull back to Weekly 200MA pre-ER. Analyst event with Antoni Ribas at ASCO 2018. Idera as well. Systemic infection transiently increases Myocardial Infarction or Stroke risk, but not vaccination (Flu vac prevents).||2018-05-08|
|ABUS||Add 421 shares ($2.6k)@$6.15 upon breakout cup-with-handle pattern||2018-05-08|
quizartinib first Flt3 inhibitor for AML. $410 million buyout of San Diego-based Ambit Biosciences in 2014
Autolus utilizes rapamycin activated Caspase 9, a cell therapy safety switch to selective elimination of programmed T cells
|Ascletis||first HKEX pre-revenue IPO. ex-GSK Wu JInzi. HCV leads||2018-05-08|
绿叶制药 bought $AZN Seroquel regional rights for $538mil
$VRX Valeant changed name to Bausch Health Companies with Bausch & Lomb
diving into CNS diseases RNAi into the brain and spinal cord area using intrathecal injection amid Amyloid beta failures
$ALNY $AKCA FDA Briefing doc highlighted volanesorsen bleeding risk (55% below 10^5/ul vs none in control)
Singapore’s Aslan tanks on Nasdaq debut, raising $42M in IPO (half of expected) biliary tract cancer. Weak IPO.
Esketamine hit and miss in first pivotal trials of hard-to-treat depression
Genentech R&D leader Dietmar Berger moves to Atara Bio, heading up off-the-shelf allogeneic EBV associated T cell work. Michel Sadelain of Memorial Sloan Kettering
|Biotech||fear over drug price controls from administration. Trump to speak. Endpts call "boiling point". Hemo gene therapy $1.5mil?||2018-05-07|
Sarepta’s eteplirsen spurned as European regulators turn thumbs down on controversial Duchenne MD drug
andexanet alfa approved via accelerated approval pathway; post-marketing trial needed
this metabolite of Ozanimod is ~90% of AUC in humans… this metabolite is effectively the drug
Stannsoporfin is a heme oxygenase inhibitor for jaundice bilirubin. 3-21 AdCom
|AKAO||AdCom split on two indications for this new antibiotic||2018-05-04|
FDA allow lumasiran in the ultra-rare primary hyperoxaluria type 1 (PH1) using surrogate biomarker urinary oxalate
|Casma||Autophagy for neuro disease||2018-05-04|
|ABUS||Moderna challenging ABUS '127 '435 patent, claim same old patent repackaging||2018-05-03|
Elon Musk Rejects ‘Boring, Bonehead Questions,’ from analysts
|ABUS||Moderna/Merck targeting KRAS with mRNA but denies ABUS' IP||2018-05-03|
|JNJ||Janssen bought oncolytic virus company BeneVir||2018-05-02|
bempedoic acid lukewarm efficacy, safety concern, low price position
|Refuge||mutated Cas9 as TF to turn on genes||2018-05-02|
|ABUS||Many abstract using LNP for gene editing delivery at ASGCT 2018, such as Bluebird||2018-05-02|
|ABUS||Genevant website online||2018-05-01|
multiple myeloma patients who had proved resistant to a long slate of drugs, 25.4% ORR
Gilead Immunoscope combines laboratory phenotyping and computational analysis to profile the immune system.
oral neuronal nicotinic receptor (NNR) assets for cough
|4DMT||Roche partnership gene therapy AAV platform||2018-05-01|
|INCY||dump multiple programs with $BMY $MRK $AZN||2018-05-01|
|Crescendo||Humabody Vh small size, 1/4 Fab, 38kd for trispecific, rapid penetration in tumor and clear in circulation. Easy design.||2018-05-01|
|AGN||IL-17 for psoriasis discontinued.||2018-05-01|
|Synthorx||Synthetic Biology expanded genetic code to 172 AAs. Lead IL-2 without side effects. OrbiMed||2018-04-30|
ALXN1210, a long-acting form of its drug Soliris Q8W vs Q2W
|AGRX||released adhesion and wearability profile at ACOG. But no correlation with efficacy||2018-04-27|
|ACRX||positive CHMP opinion. up 6.5%||2018-04-27|
|Mammoth||Jennifer Douhna using CRISPR for cancer/rare mutation diagnosis. Remember the paper.||2018-04-27|
信达生物 Innovent Biologics has a full pipeline of antibody biosimilars
SUPRA CAR-T require 2 signal to activate and an on-off switch to control side effects. Wilson Wong, Timothy Lu, Jim Collins
ubrogepant, oral calcitonin gene-related peptide (CGRP) receptor antagonist, PhIII results, NDA in 2019
FDA requires more dose-ranging trial before move into Phase III for Cystic Fibrosis CF. Also competitor Galapagos $GLPG.
|CELG||Celgene refuse-to-file was due to newly identified active metabolite. still rise 3%||2018-04-26|
|ACAD||tanks after CNN reports FDA safety investigation||2018-04-25|
FocalView, an app to track disease progression in patients with ophthalmic disease real-time.
|ADC Thera||ADC targeting Her2 discontinued due to poor safety at high dose and low efficacy at lower dose. After $200mil financing||2018-04-25|
Former Alexion team purged by Ludwig Hantson came together for a startup.
|ACRX||on April 23-26 CHMP agenda. Share price is quiet. News expected Friday morning.||2018-04-25|
Genevant Chairman appointed Clarus partner. sdfad. LNP steroids safety further validated.
EZH2 inhibitor tazemetostat on clinical hold for a pediatric case of secondary T-cell lymphoma.
Bankrupted and sold for $75mil to Nalpropion. Contrave maker commercial failure
nature’s selection of molecules to bind to targets that couldn’t be bound to synthetically. anti-fungal to SHP2 PTP inhibitors
|Cedilla||protein degradation using small molecules, focusing on oncology||2018-04-24|
baricitinib (JAK1/2 inhibitor) adcom 2mg 10-5 4mg 5-10 needs more safety data on thrombosis. Rejected 2017. allowed Lilly to refile as second-line therapy without the added data. Pfizer’s Xeljanz (tofacitinib) already marketed no safety concern.
Pharma Research and Early Development (pRED), Genentech Research and Early Development (gRED), Chugai in Japan
|DRNA||Dicerna hired Merck RNAi scientists when Merck sold RNAi assets to Alnylam. IP lawsuit now resolved with cash and equity||2018-04-23|
|AVXS||deal history and details. confident and patient, bids from three companies.||2018-04-23|
antibody drug company, but couldn't find their unique edge. Failed PhIIb PhIII for AL amyloidosis.
glembatumumab vedotin ADC that targets gpNMB compared to Xeloda in triple-negative breast cancers failed PFS
FDA approved Ultragenyx's Crysvita for X-linked hypophosphatemia (XLH) in adult and pediatric
FDA approved Tavalissetm (fostamatinib) for chronic immune thrombocytopenia (ITP)
|ARGS||Argos individualized DC immunotherapy. PhIII discontinue. Delist from NASDAQ||2018-04-22|
Bluebird’s gene therapy for beta-thalassemia falls short of a cure, but still wows in 22 patients
an AI “brain” holds “50 billion biological data points and complex biological concepts – the world’s largest
FDA director of CDER Division of Pulmonary, Allergy and Rheumatology Products Badrul Chowdhury to head Respiratory, Inflammation, and Autoimmunity, Innovative Medicine and Early Development Biomed Unit.
|FCSC||Fibrocell fibroblast cell gene therapy waving white flag and looking for reverse merger||2018-04-18|
publication in Anesthesiology - the best journal in the field
|NLNK||scrape its IDO program in light of $INCY 's IDO1 failure. Evaluating strategy.||2018-04-17|
|GWPH||FDA briefing doc positive. Up 11%. Also citing manageable liver issue||2018-04-17|
69 enrollments as a late comer. Great execution by Checkmate. $DVAX is falling behind, despite an early start
|Checkmate||Art Krieg's Checkmate CMP-001 oral presentation in reverse PD-1 resistence||2018-04-16|
|IDRA||get funding to expand IMO-2185 into more trials. still down with others $DVAX||2018-04-16|
|ALKS||FDA reverse refuse to file||2018-04-16|
monoclonal microbial to modulate immune system for cancer and inflammatory diseases. #IPO #microbiome
filed confidential treatment request on a bunch of commercial deals with 3rd party suppliers detailed in 10K. No buyout
|DVAX||$MRK NSCLC chemo combo data impress 12m OS 69.2% vs 49.4% Ctrl. Median PFS 8.8m vs 4.9m. I/O combo down $NKTR. Updated data; 33% 6/18 ORR in HNSCC. 86% response ongoing in MEL-01 after 18m. Sell on news.||2018-04-16|
HF study complete. Reaffirm 2Q resubmission. Break above $2.35 (6 month high). HF是没啥悬念的 那个24 hr max也没悬念 只不过在CRL之前很难预见会有这样的问题 股价当时涨的太猛是个问题，但也是事后看。事前很难说有胆识在$5.5退出。
David Hung wipes Axovant from his work history
|DVAX||Abstract embargo lifted 40% ORR (4PR) in 10 pts vs historical 13-16% PD1 mono. Melanoma 88% 12m PFS 89% 12m OS||2018-04-14|
poziotinib inhibits EGFR, HER2/neu, and Her 4 covalently. 11 NSCLC 64% ORR.
Serlopitant, NK1-R antagonist. for pruritus in atopic dermatitis (AD) did not meet. Also for cough.
|ILMN||FDA releases NGS and oncology diagnostic guidelines||2018-04-13|
Speculation: MM retires, new CEO with ID experience and Genevant/3rd party deals for IPO. Replicor PPT
Enterprise Therapeutics target the ion channels TMEM16A and ENaC. improving hydration, clear away mucus in COPD and asthma. not genetically calibrated but broad patient populations
|Tessa||Virus specific T cell for virus related cancer. EBV, HPV, and two CAR-Ts||2018-04-12|
|ABUS||preclinical combo data release for 2 gen AB-506, RNA inhibitor AB-452, GalNac AB-729 at EASL2018. No immediate impact.||2018-04-12|
Deal. 1. Genevant may do R&D on its own, not just licensing to Moderna, Sangamo etc. 2. High caliber recruits. 3. No financial or ownership details are disclosed. no price movement next day.
|ARWR||release 9 patients ARC-520 data w. ETV at EASL2018. Not impressive. $ABUS||2018-04-11|
late 2015 it slashed ORR on rociletinib NSCLC to 34% 625-mg 28% 500-mg arm, a plunge of 20+ points. CEO Patrick Mahaffy, had been purposely misleading investors with a false portrait of the data. rival to Tagrisso. Later PARP shines.
|AMGN||expands Rhode Island previous Immunex manufacture facility with flexible modular design||2018-04-11|
|ALXN||buyout Wilson Therapeutics $855mil for WTX101, binds to copper and albumin to clear Cu in Wilson disease.||2018-04-11|
|VTVT||another Alzheimer failure with discarded drug. Worse than placebo. Down 94% from IPO.||2018-04-10|
#epigenetics CPI-1205 blocks Enhancer of Zeste Homolog 2 (EZH2), over-expressed or mutated in many cancers
MGTA-456, first-in-class allogeneic stem cell therapy consisting of a single umbilical cord blood unit expanded with an aryl hydrocarbon receptor (AHR) antagonist then administered to a patient through BMT
|MRK||succeed PD-L1 >=1% NSCLC PhIII trial. Previous $BMY fail. Better trial design||2018-04-09|
Avexis spinal muscular atrophy #genetherapy buyout by $NVS. 10X 2y IPO. Chairman Dan Welch was CEO of Intermune
acquired a RIG-I company RIGONTEC in 09.2017; 2018 AACR includes a STING agonist MK-1454 and SD-101 stuides
Sarepta’s patents be seized by government? Patient advocates pitch controversial drug pricing proposal. $300k
Unity Biotech. IPO ridding bodies of senescent cells for ageing.
the warning letter, FDA observed “multiple poor aseptic practices”, hence CRLs for Rituxan, Herceptin biosimilars
BioCryst and Idera to Merge to Serve More Patients with Rare Diseases
$MRK $DVAX $NLNK IDO1/PD1 Keytruda/epacadostat combo failed hazard ratio 1.00, reverse PhII results. Art: combining two checkpoint inh., but not activating immune system. STING, TLR7/8, RIG-I not validated in human. AdamF: first real test of I/O combo. Loncar: @WilliamBlair MRK didn't have epaca/keytruda in a lung cancer pipeline slide "just a clerical oversight"
NASH PhIIb trial failure. No difference. some encouragement in subgroup analysis for advanced fibrosis and early cirrhosis.
the only drug targeting SIRP-alpha and preventing CD47 from binding to it.
bought microbiome C. difficile drug RBX-2660 from ReBiotix. leadership in gastroenterology and microbiome $MCRB
|Terns||Weidong Zhong 钟卫东 as CEO, also CSO 苏州银杏树(HCV)，杭州先为达顾问(NASH, NAFLD) ||2018-04-05|
autologous T cell and NK cell therapies. P-BCMA-101 for multiple myeloma
Weidong Zhong. In licensing Eli Lilly, farnesoid X receptor (FXR) agonist, TERN-101, a semicarbazide-sensitive amine oxidase (SSAO) inhibitor, TERN-201.
The control eyes did as well with their eyesight as the treated. a bilateral treatment effect. SD-OCT demonstrated statistically significant preservation of both retinal ganglion cells and retinal fiber layer. down -34% mystery shy.
|Sigilon||Flagship-seeded Sigilon, $473 million deal with Eli Lilly on stem cell Type 1 diabetes, $63 mil upfront||2018-04-04|
protein degradation by recruiting E3 ligase. Series C $50M fund. C4 Therapeutics and Kymera same strategy.
dacomitinib EGFR inhibitor for NSCLC. Priority review
Kite vets Arie Belldegrun and research chief David Chang launched with $300 million and a collaboration with Cellectis after bagging full portfolio off-the-shelf CAR-T drugs in development at Pfizer. South San Francisco
Oral SYK inhibitor for IgA Nephropathy failed PhII. NDA on Immune Thrombocytopenia, PhII Autoimmune Hemolytic Anemia
|AZN||anti-CD22 for 3rd line hairy cell leukemia||2018-04-03|
Galena's NeuVax is the E75 synthetic peptide from HER2/neu proto-oncogene (HER2/neu p366-379) combined with rhGM-CSF
MN-001, (tipelukast) small molecule anti-fibrotic and anti-inflammatory, leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and 5-lipoxygenase (5-LO). small Phase IIa NASH study, reducing triglycerides
|Macrolide||same scientific founder Andrew Myers as failed Tetraphase $TTPH||2018-04-02|
CDK 4/6, IL-17, IL-23, PCSK9, CGRP,” Skovronsky, the former CEO of Avid Radiopharmaceuticals. “Our scientists were among the first working on these targets. we were slow getting up the courage to move into human trials.
FDA would not review the Alkermes drug, ALKS-5461, because of “insufficient evidence of overall effectiveness,” additional “well-controlled clinical trials” needed. three phIII trials of ALKS-5461 in treatment-resistant depression. Two failed to hit their primary endpoints. Alkermes argued the “totality” of the depression data showed ALKS-5461 to be effective. #refuse-to-file
sequential parallel comparison design SPCD. the first round of placebo patients who don’t respond to the drug are re-randomized between the drug arm and the sugar pill, in order to quell the high placebo responses that have scuttled numerous other trials for depression. If this drug failed to get past Janet Woodcock as well as FDA commissioner Scott Gottlieb, after the FDA reversed three other rejections early in Gottlieb’s tenure at the agency, it’s unlikely circumstances will change now.
Outstanding Shares: At March 6, 2018, 55.1 mil common shares. 5.4 mil options and 1.2 mil convertible shrs, which will be mandatorily convertible into 22.6 mil shares on October 18, 2021. total 83.1 million
01.29.2018 CRL concern include clinical data, human factors validation study and product quality.
NKTR-262 (TLR7/8) started (2.16.2018) a Phase1/2 trial recruiting 393 patients in 8 different cancers, but only 2 locations.
$NKTR rose 10 fold in a year. $DVAX
|CLDX||Our collaborator at CellDex progress Flt3L CDX301 into PhII cancer trials||2018-03-31|
|ZSAN||Zosano 1:20 reverse split to 2mil shares and $10m Mcap. Then raise $50m for 10mil shares at $5. Was $26 3 weeks ago.||2018-03-31|
Precisa is Edge’s programmable, biodegradable polymer-based platform. an external ventricular drain (EVD) vs oral nimodipine in adults who suffer an aneurysmal subarachnoid hemorrhage (aSAH) resulting from a ruptured brain aneurysm. #PhIII failure
an inhaled, dual inhibitor of PDE3 and PDE4 and stimulating the CFTR, "RPL554 has the potential to be a more effective and better tolerated treatment of COPD than existing standalone PDE4 inhibitors. ... other respiratory diseases, including CF.
|DVAX||AZD1419 PhIIa completion date adjusted from 09/03/2018 to 09/28/2018. IV board is skeptical about SD-101 results and concerned $NKTR competition NKTR-214 (IL-2R) and NKTR-262 (TLR7, TLR8)||2018-03-30|
$IONS $PFE Pfizer’s positive PhIII tafamidis data makes drug a new rival
04.02.2018 further panic drop
MN-166, a old drug called ibudilast, repositioned for neurodegenerative disorders and substance abuse. fail
|Fujifilm||buying cell culture media companies due to rise in IPS and cell therapies||2018-03-29|
|REDX||Porcupine inhibitor Wnt pathway RXC004 safety issue, to try low dose||2018-03-29|
|AGRX||Perceptive increased position by 150K now above 10%||2018-03-29|
|ABUS||Moderna is still working on LNP, hiring postdoc||2018-03-29|
ABUS Galnac abstract fo EASL along with AB-506 (2nd gen capsid) and AB-452 (RNA destabilizer)
appointment of John Saia as General Counsel. from McKesson Corporation, where he most recently served as its Corporate Secretary and Associate General Counsel. included leading and supporting nearly 100 acquisitions. Prior to McKesson, was a senior attorney at DLA Piper, advising clients on capital markets transactions, public reporting and M&A. Earlier in his career, was an attorney and special counsel at the U.S. Securities and Exchange Commission (SEC).
|DVAX||WHO call for better HBV treatment $ABUS||2018-03-27|
|ABUS||$ARWR begins dosing. Ego@IV discuss how rushed they are and how they sell their stocks||2018-03-27|
Biohaven’s oral rimegepant (BHV-3000) show non-competitive results. pain freedom rate was 19.2% and 19.6% for the drug, versus 14.2% and 12% for the placebo arm. Freedom from MBS was 37.6% and 36.6% versus 25.2% and 27.7% in the sugar pill group.
Enfortumab vedotin (ASG-22ME) is an antibody-drug conjugate (ADC) composed of an anti-Nectin-4 monoclonal antibody attached to our synthetic cell-killing agent, monomethyl auristatin E (MMAE). FDA Brealthrough
Sanofi's ABlynx, nanobody against IL-6R vobarilizumab failed in PhII lupus. Failed before in PhII RA.
peptide ulcerative colitis drug PTG-100. High placebo response
CD47, CD73, tumor microenvironment, Surface Oncology
extended spectrum β-lactamase inhibitor known as AAI101 against multidrug-resistant gram-negative bacteria
Ralinepag (APD811), is an oral IP receptor agonist targeting the prostacyclin pathway for pulmonary arterial hypertension (PAH).
Etrasimod (APD334), is an oral S1P receptor modulator, targeting S1P receptor subtypes 1,4 and 5 in autoimmune diseases such as ulcerative colitis.
|ACRX||Add 960 shares ($2k)@$2.05||2018-03-23|
Yesterday may be to shake off the weak hands before the big news. Nothing unknown told by the Wedbush analyst. Volume swelled a little, but not too much. Panic / uneasy on the IV board. 3.23.2018 Further up in bigger voulme, despite a big down day for Biotech.
$ALNY found genetic factor HSD17B13: touted as PCSK9 of NASH
|ABBV||During my New York trip to Bio Reunion, Jinghan Hao (Zhou Mo's wife) told me StemCentrx, its DLL3 cancer stem cell target pipeline was bought by $ABBVie for $5.8B cash and $4B milestones. Now it is a flop, PhIII failure. Be careful of new unproven hard to understand MOAs.||2018-03-22|
|Moderna||HK and NASDAQ dual IPO as early as 2019. Also Grail||2018-03-22|
Falling behind giant migraine drug rivals, Alder ousts founder Randy Schatzman, recruited a CEO with prior sale experience — could a buyout be next? $AMGN $NVS Aimovig (erenumab) under review presented nice PhIIIb results in 2018.01. Aimovig unique anti-CGRP Receptor MOA.
drop 28% ( $6.1 -> $4.4 ) after Q4 no deal / no progress report. Speculators leaving. No buyer.
|AGRX||drop 25% after Q4 no progress report. Speculators leaving. No buyer.||2018-03-21|
|DVAX||Add 115 shares ($2k)@$17.30||2018-03-21|
|CHMA||MPOWERED trial more responders than expected. ~130 instead of ~150 patients is needed.||2018-03-20|
High profile investor Sahm Adrangi’s Kerrisdale launched a short attack on PTI "breakthrough designation" and PhII data. "... tiny placebo arm (4 patients) had a sharp, sudden and unexpected drop in lung performance during the 28-day trial that created a gap favoring the drug." Came horus after PTI plan to raise capital. Also attacked Allied Minds (LON:ALM) and Prothena (PRTA). cancelled offering the next day due to “market conditions”
FDA approved its diet pill Belviq (Lorcaserin, activates 5-HT2C receptor) in 2012.06.27 But share price declined ever since -99%. Reverse split. Layoff. Sold rights. Many other prescription diet pills all fail. #commercial
|NOVN||also had positive PhII results in 2015.09.29. p < 0.01. didn't translate in to PhIII||2018-03-19|
|DERM||its PhII results on 2016.5.10 reported positive results with p<=0.001. Then PhIII completely mirror placebo||2018-03-19|
Huiying LI (UCLA) told me. Using Ammonia Oxidizing Bacteria Nitrosomonas eutropha found in soil to produce Nitric Oxide to treat Acne. Passed PhII.
|NOVN||NOVN asked for a pre-NDA meeting, FDA advised another pivotal trial (a guidance meeting). Seeking third party funding to develop ance indication.||2018-03-17|
repeat failed PhIII with more agressive dosing , fail again. Lost 99.5% value since 2015 high.
|SLDB||DMD AAV gene therapy. Recent 01.2018 IPO. Clinical trial hold and halt on adverse event of first dosed patients. Tank 66%. CEO is a DMD dad. James Wilson resigned from its advisory board to publish paper on #AAV safety concern. #LNP $SRPT #transparency $UNUM also revealed death after IPO.||2018-03-17|
|ALXN||Alexion reported 2nd gen PNH drug ALXN1210 non-inferior to its own Soliris ($540k/y), but superiority not significant. Competitor $APLS (recent IPO) coming in. Revenue highly dependent on Soliris/PNH.||2018-03-17|
3rd PhIII failure. Keyzilen(AM-101) blocks cochlear NMDA receptors to suppress the aberrant excitation of the auditory nerve that is perceived as tinnitus. 1:10 reverse split.
Orexigen, plummet 96% from height in 2015. Despite a best-selling weight loss drug, has faced hurdle after hurdle, including a legal fight to defend patent rights (won against Actavis) and a lackluster market for diet pills in general. Failed to reach $100 million in sales by the end of 2017, triggered a payment it could not afford. #Commercial #Debt
licensed inotersen AKCEA-TTR-LRx to Akcea ( AKCA 75% owned by IONS after deal)
Noacne. Nobel winner Lou Ignarro said Nitric oxide NO is not antibiotic, it is what WBC use to kill bacteria
Lundbeck bags a PhII Parkinson’s drug with $1.1B buyout deal. mGluR4 as an alternative to using dopamine to control the motor symptoms of Parkinson’s. François Conquet founded Addex back in 2002 and ran it for three years, leaving it with an mGluR5 program.
|Arbor Biotech.||New and smaller Cas13d. Co-founded by Feng Zhang. Also touts AI, computational systems pharmacology for efficient drug discovery. Same enzyme reported by Salk research in the same issue of Molecular Cell, can also edit RNA. #EDIT #CRISPR||2018-03-16|
|DVAX||AACR abstracts out embargoed. Both Dr. Cohen and Dr. Ribas to give poster presentations.||2018-03-14|
|ABUS||Q4 report. No deal yet with Roivant. Candidates progressing. IV post shows me their long past history of disputes over LNP. Sue. Merge.||2018-03-14|
Founded by ex-NBIX people. CHMA competitor: Small molecule nonpeptide somatostatin agonist CRN00808.
|NOVN||Wen recommended Noacne, which follows NOVN's NO tech. Micro cap <$100M. Discordant PhIII results for acne reported in 2017-01-27. PhII anti-fungal reported 2017.04.12||2018-03-14|
up 50% on cystic fibrosis breakthrough status
Protalix, oral anti-TNF for ulcerative colitis. hTNFRII-IgG1Fc fusion. PhII 24 patients (18 completed, 67% response, 28% remission). avoid immunogenicity, malignancies and opportunistic infections
|TEVA||returns CGRP antagonist small molecule to Sosei. Its own anti-CGRP antibody falls behind competitors, losing market potential.||2018-03-13|
|AGRX||Q4 Report Type A meeting requested. Expect resubmission Q2, 6 months review.||2018-03-12|
anti-miR-17 started in hepatocellular carcinoma (HCC), ended up in kidney disease ADPKD
glycobiology, galectin inhibitors, announced AML OS as endpts, maybe good. Rivipansel vaso-occlusive crisis in phase III with Pfizer. put NASDAQ IPO photo on about us page #adjuvanttherapy
Trilaciclib is a first-in-class short-acting CDK4/6 inhibitor to preserve hematopoietic stem cells during chemo. Positive Phase 2. MCap already high 1B. Insider selling OK. A MedImmune venture #adjuvanttherapy
Phase III complete failure reverse from Phase II. Previous note right on high price and consistent insider selling. #acne
New route injection to the back of the eye through the Suprachoroidal Space (“SCS”) for uveitic macular edema, can combine with Avastin or Eylea for Retinal Vein Occlusion etc. #procedure
Phase III failure. Angiogenesis-specific sensor (VBL’s PPE-1-3x proprietary promoter in Adeno 5 vector) with gene payload to specifically induce cell death in angiogenic endothelial cells in the tumor milieu. #AAV #genetherapy
|DVAX||Half hour sell off after ER, then reverse.||2018-03-08|
|ACRX||Meeting minutes not surprised. Zalviso sales will be slow until 2019.||2018-03-08|
|XENE||Nav1.7 inhibitor rare mutation no Pain. Topical didn't meet endpt. Genentech working on oral selective inhibitor.||2018-03-08|
|Roivant||Vivek Ramaswamy’s public companies. Model: take big companies low priority drugs and develop it separately (reduce "traffic jam”), new venture for Diabetes: Metavant||2018-03-08|
|Refuse to file||manufacture related; production record (ACOR); device information (STDY); additional information.||2018-03-08|
|OTIC||OTIVIDEX is a sustained-exposure formulation of the steroid dexamethasone for Ménière’s disease. Miss phase 3. No significant insider selling. Trading below cash value now. Valued $1B post IPO in 2015. Lukewarm MOA.||2018-03-08|
|Commercial Failures||DNDN (8bil), MNKD (4bil)||2018-03-08|
|ADRO||STING pathway leader and other immunooncology||2018-03-08|
|ACAD||09.09 miss phase III; 2010 initiate new pIII; Nov. of 2012 met EP. Took 3 years and positive results to revive the stock. Be patient.||2018-03-08|
|ABUS||Regulus using LNP to deliver Anti-MiR for HCC. Gritstone/ALNY/SGMO/CRSP/NTLA/Generation Bio/Moderna/Regulus||2018-03-07|
|RGLS||4Q CC announced challenge recruiting patients to Alport trial, now enroll til 2H2018. ADPKD progress OK. Down big 20% next day.||2018-03-07|
|Osel||Microbiome therapy for vaginitis, inspired by Wen||2018-03-07|
|GILD||HIV shock and kill to reactivate reservoir||2018-03-07|
|ABUS||Chat w. Dr. Saab Dr. Nazem Afdhal (Spring Bank)||2018-03-05|
|AGRX||Wen Mao recommended Evofem. Its totally not as good as Agile. Still same market cap. 1) cheap ingredient 2) poorest category for efficacy 3) nobody will use.||2018-03-05|
|DVAX||SD-101 trial 7 sites withdrawn. Why? DV281 3 more 4/5 recruiting.||2018-03-01|
|RUBY||Rubius Red Cell Platform, 2018.06 IPO||2018-03-01|
|Pear||Prescription digital medicine, app to manage neuro disease||2018-03-01|
|CognitoTx||Brain wave removes plaque Nature Podcast||2018-03-01|
|ABUS||Generation Bio uses LNP to deliver ceDNA; Moderna now valued at $7.5B, possible $20B IPO||2018-02-27|
|ACRX||Read Acelrx received Day 180 questions to Feb CHMP during 19-23Feb. Addfirstname.lastname@example.org||2018-02-27|
|Moderna||19 pipeline; value at 7.5B pvt. 20B IPO?||2018-02-26|
|SGMO||ZFN gene editting; GILD CAR-T deal; LNP license||2018-02-24|
|RGLS||Wuxi STA manufacture partnership with RGLS.||2018-02-22|
|DVAX||ACIP recommendation. 2.20.2018 $175M ($100M+75M optional) loan. Abstract submitted.||2018-02-21|
|ACRX||RBC conference. Zalviso will be delayed after Dsuvia resubmission by 1H18. 2.23.2018 FDA approved KMPH’s Opioid pain killer without abuse deterrent label||2018-02-21|
|AIMT||Phase III good, but pop then sell off the same day||2018-02-20|
|APRI||topical for ED. CRL for CMC and Safety||2018-02-18|
|PCRX||Old candidate using DepoFoam technology, approved since we studied; but share price kept falling since 2015. AdCom4-6||2018-02-17|
|ATRS||Partner product for preterm birth approved||2018-02-17|
|RGLS||Read RGLS investor village board. Seems lots of speculation and not so much high quality post. Wait for TA and response to news.||2018-02-16|
|DVAX||Nektar big deal with BMY for its IL2R(CD122) agonist.||2018-02-14|
|ABUS||CFO Departure after Roivant deal close and consolidation to PA. 2.14.2018 negotiating LNP joint venture with Roivant. People on IV are confused and split. Ambiguity aversion?:) 2.19.2018 No hearing listed on court website. 2.20.2018 Settled and Cancelled? 2.22.2018 Settlement announced. Only 4 Moderna vaccine sublicense survived.||2018-02-13|
|OPK||Now $3. Great decision I sold. Revenue declined! $2.5 12.2018||2018-02-12|
Back to $1.5. Expect a long flat base.
|AXON||another fail on DLB. CEO David Hung left 10m in position||2018-02-12|
|DVAX||Read more about OX40 big company pipeline and Idera merge and IMO-8125 phase III||2018-02-05|
|ABUS||Add 1k(email@example.com) 2.8.2018 Consolidate HBV business to Penn, USA. Negative sentiments on IV forum. ABUS may divest LNP to Moderna or ALNY, Mark Murray may retire along with that.||2018-02-05|
|DVAX||AZN Other Asthma fails. Ron Levy SD-101+aOX40 STM paper 2.5.2018 add 84@$17.85(1.5k)||2018-02-02|
|ABUS||AAV safety problems.||2018-01-30|
|ABLX||Nanobodies, bot by Sanofi||2018-01-29|
|ABUS||Read ego@IV’s analysis on injunction ruling ABUS vs. Acuitas and SGMO relationship. and ABUS VIDEO.||2018-01-25|
|DVAX||Add $firstname.lastname@example.org more at 200MA; Add $email@example.com||2018-01-19|
|ABUS||Add $firstname.lastname@example.org more near 200MA.||2018-01-19|
|DVAX||Found ONCS plasmid-IL-12. They achieved 50% ORR in patients unlikely to respond to anti-PD-1 therapies. They didn't say PD1 refractory directly, but DVAX only achieved 1/12 PR in this population.They don't have PD1 naive data published. But the 50% on anti-PD-1 unlikely-responder is really impressive and much better than SD101. But ONCS has only 65mil in marketcap. Did I miss anything?? More thoughts:1. The delivery route injection+electroporation is kind of too complicated. Cannot work easily for lung cancer for example. 2. Their most advanced trial is in PD-1 refractory patients. Not PD1 naive patients, one trial is planned though. this trial population is NOT PD-1 refractory patient at all. 10 of them may have seen 1~4 cycles of aPD-1. But they are nonetheless "predicted" non-responders. I found them a little fishy trying to make people think they did it on refractory patients. 9 out 22 41% CR is still impressive, good for those patients.||2018-01-16|
|SGYP||GI Fluid regulators||2018-01-15|
|MDGL||NASH trial success announced 12.6.2017||2018-01-15|
|KDMN||ROCK inhibitor for autoimmune and fibrosis; too much debt, interesting MOA; major holder selling||2018-01-15|
|DERM||Dermatology, Acne by targeting sebum enzyme, not cheap stock, low but consistent insider selling||2018-01-15|
|BHVN||Oral CGRP inhibitor; moderate insider selling||2018-01-15|
|AXSM||a few neurology drugs don't understand; AXS-02 pain inhibitor (by inhibiting Osteoclast secreting proton) discontinue one but continue on another Knee trial||2018-01-15|
|ARDM||Inhalable form. Cipro for lung diseases; mediocure trial efficacy results; AdCom not very good.||2018-01-15|
|ALDR||another CGRP for migraine, but worry it may not compete with Amgen's erenumab: better MOA and safer||2018-01-15|
|DVAX||JPM presentation: collaboration with Serum Institute of India on new vaccines. SD101 Phase III by YE18, DV281 Phase II early 2019, Advancing CpG-nano for Liver and TLR7/8 ligands. MK1966 combo failed?||2018-01-11|
|AGRX||Pop up $3 due to 13G 9.9% stake by Perceptive Advisors.||2018-01-09|
|DVAX||Heplisav-B launched. WAC $115/dose, $230/regime; CDC listed Engerix-B $55.65/dose.||2018-01-08|
|DVAX||Cash YE $191.7M, same as Q3; IBD interview confident launching on their own; AZD1419 completed enrollment actual enrollment 81 vs. 67planned.||2018-01-05|
|ABUS||Acuitas discussion on IVillage. Sangamo used Acuitas LNP.||2018-01-05|
|NKTR||NKTR-214 IL2R agonist, stimulate T and NK cells.||2018-01-01|
|DVAX||MK-1966+SD101 combo completed enrollment, preclinical Abstract; possible readout on ASCO18; H&N paper (JCI insights 09.2017)||2017-12-31|
|VNDA||previous PSIC candidate; not so impressive revenue with two products.||2017-12-30|
|BOLD||AAV gene therapy for MTM1 mutated X-Linked Myotubular Myopathy||2017-12-30|
|AGRX||A flock of analysts downgrades at $2; when they upgraded at $5.||2017-12-26|
|LJPC||angiotensin II for IV. No big change after approval||2017-12-23|
|AEZS||macrilen for aGHD. know this CRL for long time. Horrible company price history. Still only $50M cap after approval.||2017-12-23|
|AERI||Approved no big change.||2017-12-23|
|ABUS||Acuitas trial date 2.19-3.2.2018||2017-12-22|
|AGRX||99.2-99.7% scored 0-1 for adhesion. FDA probably wants to know detailed analysis between 0, 1 (separate from 0), and 2-4 groups on efficacy, safety, compliance, dropouts and withdrawals, before it can agree on the label.||2017-12-22|
2nd CRL: Adhesion issues (unexposed risk) on CMC and trial results interpretation. Cash can fund till YE2018-1Q2019 if no new activity required.
|ONCE||An-chieh told me. Heavy selling. Eye drug approved but hemophillia fell short. Share price halved||2017-12-22|
|AGRX||Ortho Evra had BMI warning.||2017-12-20|
|ACRX||Read posters 309 and other publications: better satisfaction and less failed analgesia; less oxygen desaturation; no active metabolite; no need to adjust dose due to comorbidity; no dose stacking.||2017-12-19|
|RGLS||RGLS4326 phase 1a in healthy volunteers initiated.||2017-12-19|
|NVAX||phase 3 failure. Used to worth 3.4B and $13 now 200M and less than $1. $300M debt financing red flag. Continue to disappoint||2017-12-19|
|NLNK||IDO drug pulled out promising combo data with Keytruda after disappointing news with Genentech earlier pullout. Skeptical. Crazy 2day rise. Later this rise phases away.||2017-12-19|
|ABIO||A tiny company with new beta-blocker; 17M Mcap, 8M Cash||2017-12-16|
|EIGR||LTB4 inhibitor for Pulmonary Hypertension; good chart||2017-12-15|
|ACRX||ARX-04 NDA: no big change since. Different reaction compared to 2013 due to different market condition and ACRX expectation||2017-12-13|
|ARGX||ARGX-110 anti-CD70 for cancer; positive Phase II data at ASH 2017; more: anti-MET, anti-GARP||2017-12-13|
|DVAX||Added to XBI index between 20170908-1211||2017-12-11|
|ABUS||Added to IBB index. Ladenburg Thalmann unloaded in 3Q2017.||2017-12-11|
|ACRX||Type A meeting confirmed but delayed to End of January 2018; Zalviso Sep2017 patients count rose to new high of 1600 despite that hospital counts dropped to ~205 (due to trial ending in Spain and unexplained big decline in Italy). That means per hospital usage is rising, slowly yet. Total hospital in Europe more than 10,000.||2017-12-11|
|BGNE||Found moderate insider selling by CEO John Oyler||2017-12-11|
|SAGE||GABA NMDA CNS disease; Brexanolone failed in 1 trial (09.2017) but success in another (11.2017); then SG-217 success||2017-12-09|
|RVNC||Botox-like for skin wrinkling; aesthetics||2017-12-09|
|RARX||RaPharma; Complement C5/C5b inhibitor; as Alexion C5 inhibitor competitor||2017-12-09|
|MLNT||Fusidic acid (approved in other countries) for ABSSSI. Small MCap even though one approved product||2017-12-09|
|KALA||MPP tech for better eye delivery; NDA; 7/20/2017 IPO||2017-12-09|
|GALT||Gallectin inhibitors for NASH or Cancer||2017-12-09|
|DVAX||Naive fully enroll December 2017, non-naive early 2018, possible data release at ASCO2018; Sci-B-Vac (Nasdaq:VBIV) was merged on May 6 2016||2017-12-08|
|RGLS||all directors bought shares on 12.4.2017 at $0.89||2017-12-08|
|Medivation||Sold to Pfizer for 14B; product disappointing; PARP inhibitor disappointing too.||2017-12-08|
|ACRX||read about previous human factor CRLs; all approved later, 1 year delay. "Human factors studies are NOT clinical trials.” PDA comments.||2017-12-07|
|ASMB||wait for its HBV to fail and refocus on microbiome; Allergan GI deal in Jan 2017; Rise 10X from bottom in less than 2 years; potential buyout coming?||2017-12-07|
|LOXO||Multiple Cancer mutation targeting agents; 400+650 deal with BMS;||2017-11-19|
|PIRS||anticalin drug chaperon or fusion protein||2017-11-17|
|MRTX||KRAS first in class tyrosine kinase in NSCLC + Opdivo combo; NSCLC PD-1 Progress 3/11 PR||2017-11-17|
|MRNS||Ganaxolone; GABAA neurology drug||2017-11-17|
|MDGL||Thyroid Hormone Receptor beta (THRb) for NASH; Phase II success. MDGL went public by reverse merging Synta (SNTA) in 07.2016. Formed a perfect one-year tight flat base from 10.2016 to 08.2017 at MCap 185M||2017-11-17|
|IMMU||Seatle Genetics wanted to buy; venBio faught back; CEO/CSO had to leave; David M Goldenberg founded in 1985||2017-11-17|
|ESPR||LDL lowering drug||2017-11-17|
|CBAY||Liver and other chronic diseases||2017-11-17|
|CALA||Tumor metabolism; Aminoacidases inhibitor||2017-11-17|
|ABEO||AAV gene therapy||2017-11-17|
|ACRX||maximum dose 15mcg/20min plateaus at 8-12 hours; Dsuvia’s 30mcg/hour is fine||2017-11-15|
|DVAX||HeplisavB approved. Sell on news.||2017-11-09|
|RGLS||Company redesigned HERA and biopsy trial after results from ATHENA natural history study. Now expect biopsy study results 2018Q1 and HERA results 2019Q1. RGLS4326 for ADPKD IND filed. R&D reorganized to be more efficient. Buy around 2018Q2-3?||2017-11-09|
|STML||IL3R cancer stem cell target therapy||2017-11-04|
|NBIX||Ingrezza exceed estimates||2017-11-04|
|ALNY||New results show better than IONS and pathology improvement||2017-11-04|
|ACRX||Now good time to add more? Wait for TA. It tells a lot. Add more @1.9||2017-11-03|
|PTCT||Translarna, unknown mechanism on DMD, up on mixed ADCOM; CRL again.||2017-10-28|
|MGNX||DART; bi-specific and other antibodies. Incyte deal.||2017-10-28|
|QURE||AMT-061 for Hemophilia B advanced to phase III||2017-10-21|
|EXEL||Kinase inhibitors for oncology||2017-10-21|
|DRRX||long time candidate; pain medicine; POSIMIR failed phase III; remoxy long time failure||2017-10-21|
|DBVT||Food allergy skin patch, see AIMT; ViaSkin Peanut failure phase III, small diff.||2017-10-21|
|AIMT||Food allergy oral pills; heavy insider selling; see DBVT||2017-10-21|
|DVAX||DV281 NSCLC initiated||2017-10-19|
|ABUS||ALNY end ALN-HBV development; Gritstone Oncology signs LNP deal for mRNA delivery.||2017-10-18|
|DVAX||ACIP Updated agenda no vote; bear attack then reversal||2017-10-16|
|ATRS||Drug/Device combination; auto injectors; 10.2017 CRL||2017-10-15|
|ANAB||in vitro Somatic Hypermutation; 2017 IPO; P2a positive results||2017-10-14|
|AERI||new mechanisms of action (MOA) in a generation to treat patients with glaucoma. Designed to reduce elevated intraocular pressure (IOP), the cause of vision loss in open-angle glaucoma; AdCom OK, not stellar. Approved 12.23.17 no big change.||2017-10-14|
|DVAX||Read CDC/ACIP agenda first item is Heplisav-B||2017-10-12|
CRL on Dsuvia citing additional safety data needed for highest dose; and human factor study for changes in directions of use. Probably solvable.
Pre-PDUFA run was too speculative; too fast and too high; should I have sold it? Really hard. I seriously don’t know when to sell; if i do, it will start a bad habit. I didn’t add more above 5; good decision. Just keep buying when it’s cheap.
Signs of problem in hindsight: AdCom cancellation; TA; $150mil registration; lack institutional buying in the mean time; neurology indication
|ACRX||Sentiments on twitter (proven useless 10.12) are mostly skeptical short citing opioid crisis and commercial failure.||2017-10-11|
|AGRX||analyst day, lots of competent collaborator; most analysts at the Analyst Day event are gentlemen. Gender gap in financial sector is an interesting factor in its valuation.||2017-10-10|
|DEPO||found this previous candidate lost 80% value since 2015. Mostly chronic opioid pain products||2017-10-10|
|ALNY||Raised fund a few months before Patisiran data; Fitusiran fatal thrombosis; Patisiran great results. up 52%.||2017-10-08|
|ACRX||Found competitor the Medicine Company’s IONSYS withdrawn with marginal 2016 full year sales.||2017-10-07|
|RYTM||IPO. First-generation MC4R agonists were small molecules that failed in clinical trials primarily due to safety issues—particularly increases in blood pressure—as well as limited efficacy. In contrast, setmelanotide is a peptide that retains the specificity and functionality of the naturally occurring hormone that activates MC4R. We are focusing setmelanotide clinical development on obesity related to six single gene-related (i.e., monogenic) MC4 pathway deficiencies.||2017-10-07|
|MCRB||Ulcerative Colitis P1b for SER-287 results disappointing, especially clinical response; endoscopic and remission seems better||2017-10-07|
|FENC||Sodium Thiosulfate for the prevention of ototoxicity from cisplatin in pediatric patients||2017-10-07|
|ACRX||Getting nervous. Saw latest PPT, zalviso accelerating in Europe. Zalviso.eu Website well designed.||2017-10-03|
|ECYT||Licensed P3 ready candidate from Germany; share price exploded from $1.4 to $6 in 2 days||2017-10-03|
|ABUS||Roivant Sciences $116M Investment convertible at $7.13 + 8.75% per year will be converted at 4th anniversary. 13D detail; all convert at $7.13, will have 49.9% shares, will not buy more or sell for 4 years. Lots of supermajority rules. A long term investor aiming for a buyout in 4 years. 78mil (83mil) ABUS shares without further dilutiion. $5.28 per share equivalent||2017-10-02|
|ACRX||DSM SinoChem Pharma found Acelrx home page news page not available. Potential early approval? Speculation||2017-10-02|
|DVAX||Read Reuters rumor on HeplisavB deal. ABUS AASLD Ab#929 using HeplisavB; manufacture resumed||2017-10-01|
|ABUS||Abstracts out for AASLD: ARB1467+aPD1+Vaccine (That's basically HeplisavB!) PR out 10.3||2017-10-01|
|ACRX||I feel uncertain and people on twitter feel uncomfortable with the rapid run-up.||2017-10-01|
|ZYNE||First and only synthetic cannabinoid, up on P2, retrace on tweet says same as placebo||2017-10-01|
|ZGNX (Zogenix)||Up 200% on epilepsy drug; Fenfluramine, a banned anti-obesity drug due to cardiovascular issue. Now good to treat seizures.||2017-09-29|
|DVAX||ClinicalTrials.gov updated AZD1419 to "active not recruiting” on 9.22. Primary completion 9.3.2018||2017-09-28|
First patient randomized.
|ABUS||It seems Sangamo Intellia CRISPRTech all using LNP; 9.27 ARWR made a lame PR on genome-integrated HBV sAg production||2017-09-26|
|ABUS||IV post: SeekingAlpha authors earn a fee based on views, not quality. I long DVAX. HeplisavB, if successful, may reduce the HBV patient base in the long term. But that's a big if. It is also an adult vaccine, not to be used in planned children vaccination. Its impact on patient base will be slow and limited. Other vaccines are in place for a long time, but HBV cases are on the rise in recent years. As to patient base, a successful therapy would reduce patient base much faster than vaccines as we have seen with sovaldi. I strongly believe ABUS will be a player there, if not the first.||2017-09-26|
|ACRX||2 day breakout to new 52 wk high without news; continued higher like a pre-PDUFA run||2017-09-26|
|AXON||failed badly in phase 3. "Vivek's foray into Alzheimer's with left over drugs from others, not unsurprisingly fails. Market cap of 2.6 billion based on a 30yr old with a sharp suit and quick tongue.";||2017-09-26|
|ABUS||Reports promising cohort 4 data. Some sell on news; but risk off.||2017-09-25|
|VSAR/ASND||long acting hGH didn't meet non-inferiority against Genotropin, delay behind competitor -88%; Ascendis TransCon releases native GH up 23%||2017-09-22|
|ABUS||ALNY reported positive Patisiran data, superior efficacy and safety; ABUS pop 41% before closing up 21%.||2017-09-20|
Exited at $2.40 resistence to buy ACRX. (good decision 2018-03-10)
|PRQR||QR-010, CFTR F508del systic fibrosis, RNA therapeutics||2017-09-16|
|FOLD||ATB200, replacement enzyme with small molecule chaperone, already high||2017-09-16|
|FCSC||FCX-007 Col7 gene therapy, autologous fibroblast; I am skeptical about its MOA.||2017-09-16|
|FENC||List on NASDAQ from OTCQB.||2017-09-13|
|AMGN||DVAX 14:1 MI not reliable; but why Romosozumab 2.5% vs 1.9% an safety issue? Drug class effect. Ref: Osteoporosis Drugs; Risk to the Heart||2017-09-13|
|ABUS||Announced LNP webminar; Alnylam's hemophilia drug suspended due to "fatal thrombosis". Not using LNP. Webminar announced solid data; market not convinced.||2017-09-12|
|KURA||recycle JNJ old drug Tipifarnib, a farnesyltransferase inhibitor||2017-09-09|
|INSM||liposome for lung delivery to avoid charged enviroment in lung infection; improve drug delivery||2017-09-09|
|CLLS||Cellectis universal CART; clinical hold after fatality||2017-09-09|
|ITCI||FDA agrees that the metabolite is not present in human. up 40%. Doubled.||2017-09-07|
|NVS||CART approved. Oncology: “Great pricing power, fast market penetration, when target is right, ability to expand into more cancer types."||2017-09-02|
|SYRS||SY-1425 in licensed from Japan for RARA super-enhancer cancer. But heavy selling into ESMO 09.2017||2017-09-01|
|SELB||Selecta. Immuno tolerance. SVP+Rapamycin. Not very interesting.||2017-09-01|
|ACRX||talk to An-Chieh about ACRX. She think it’s great. 9.12, more: 1 rapid onset 2 hospital use disposable lock for controlled drug 3 europe approval 4 market acceptance/penetration 5 trial results interpretation important 6 policy FDA DOD partnership||2017-08-29|
|ABUS||First New 52 wk high in years. Dr. Saab (Bot around $3) and Bau (around $5) are both in ABUS.||2017-08-28|
|KITE||bot-out by GILD for 11.9B cash. 960% return since 2014 IPO @$17. Never traded below IPO price. Low $22, IPO close $29. Mostly $40-60. Then break up after Trump election. Had deal with Amgen in Jan 2015. Key people: Arie Belldegrun; NCI’s Steven Rosenberg. I was at May2015 UCLA seminar, really impressed. about $55 at that time. Didn’t buy because I don’t understand the risk, benefit or valuation. No regret. Endpts||2017-08-28|
|DVAX||UK firm Vectura announced deal with Dynavax allowing using its AKITA nebuliser with DV281 for lung cancer.||2017-08-18|
|RGLS||Listened to CC. Knew Reata $RETA as competitor. Their Bardoxolone methyl activated Nrf2 and reduce inflammation, but was discontinued in CKD patients in 2012 due to high CV risk. RGLS: it wasn't unexpected that they previously reported in diabetic nephropathy. And the main long-term outcome remains whether this will be at A) sustained and B) sustained off therapy because it is hyper filtration mechanism. $0.82. But RGLS mechanism is not REALLY different.||2017-08-18|
Announced new trial agreement with FDA. Trial results expected end of 2019. EU results 2020. So buy around end of 2018?
|DVAX||Public offering announced. 8.9 Raised $80.8m ($125 proposed) at $15 (closed at $18.65 pre-announcement). Hold above $15 next day.||2017-08-08|
|DVAX||new 52wk high. It is a pity DVAX raised fund at its lowest level in history. Even the management doesn’t know their chance with FDA. Twits:It's a pity $DVAX raised fund at darkest moment before dawn. Sometimes even insiders have no better vision of the future, but to play safe. DennisMWinters: Water under bridge...must look to future now.||2017-08-07|
|JNJ||Sirukumab (anti-IL6) AdComm 12-1 against safety. But JNJ argues benefit / risk and option. "significant immunosuppression, as increased risks of serious infection, imbalance in deaths, malignancy, MACE. Many other anti-IL6R and JAK1/2 inhibitors.||2017-08-05|
|DVAX||PDUFA delay due to REMS details. CC very optimistic. BMS acquired IFM (NLRP3 STING Innate I/O).||2017-08-03|
|ABUS||Q2 updates: 1740 discontinued. Two more candidates nominated: AB-506; AB-452 (“Company:exciting”); GalNAc RNAi. No analyst at the call. 6 presentations.||2017-08-03|
|DVAX||Q2 ER show raised 88.2 million by ATM. average $5?||2017-08-02|
|AGRX||Public offering announced. Priced at $3.75. Big drop followed (-28% to $3.30). Should have sold at $5? Don't try to time the market. It will be a bad habit. But very strong TA resistance at trend line and previous support level.||2017-08-02|
|ACRX||Great decision above. Trial results great. But sell on news as rose too much already. Wait for TA entry pattern. CC confident. I like the new CEO.||2017-08-01|
Should read more about oral delivery of peptide, annual report when above 200ma
|ACRX||PR announce CC for IAP312 results. Tempted to add more ACRX. Decided not to: 1) no $2k fund in bank 2) already rose too much in recent weeks.||2017-07-31|
|DVAX||VRBPAC AdCom 12-3-1 (Y/A/N) AH +90%; next day close +71.4% w. 23M volume (55M total)||2017-07-28|
|ABUS||ALXN terminated collaboration. -6.7%. Break 50MA.||2017-07-27|
|AGRX||FDA Accepts NDA; PDUFA 12.26.2017 +7.6% but go down for consolidation later.||2017-07-27|
|DVAX||VRBPAC AdCom Briefing doc. Down spike 18% before rise and close +5%. Down 11% 2day. More death but due to opioid overdose.||2017-07-26|
|AGRX||TA break out 200MA on volume without news (HC Wainwright initiated) 7.26 TA fill gap down 10%+||2017-07-19|
|RGLS||announced public offering. $0.91/shr; closed at $0.96/shr ($0.71/shr cash); now 66 mil cash w. 100M shares. Get in at 30c? management participated in offering. With 2 million shares.||2017-07-19|
|CLVS||EGFR NDA failure (heavy selling), down to $4xxmil mcap (about same cash but $280 heavy debt) but PARP Inhibitor shine (up 7x in a year)||2017-07-15|
|ACRX||and 7.17: sharp rise due to Jefferey’s upgrade. 7.19 new CFO, technical drop||2017-07-14|
|GWPH||offering at $90/ADS (2.8m; 25.33m total after). Wait for it at $10.||2017-07-13|
|ABUS||July presentation highlights gene editing along with mRNA. ALNY hemophilia A drug phase II release, safety issue with GalNaC (liver enzyme elevation).||2017-07-10|
|BGNE||$263m payment + $150m equity + Celgene China - BGB-A317 exAsia rights; potential Best-in-Class. PR. Fund raised in 2016.11. 恒瑞2015 Incyte $25m deal; suspended later.||2017-07-05|
|MTNB||lipid crystal delivery failed P2.||2017-07-01|
|NERV||Orexin inhibitor for insomnia. Other neuro assets||2017-07-01|
|MCRB||Seres Thera. heavy insider selling precedes clinical failure; Incyte deal.||2017-07-01|
|ITCI||PSIC #45, proposed by Lian He. Soso efficacy. Better trial safety but unfortunate toxicity in one preclinical species. Not so exciting.||2017-07-01|
|Immunocore (private Oxford)||TCR-based-targeting. To target HLA-presented cancer intracellular antigen; instead of antibody-targeting surface antigen.||2017-07-01|
|Fimbrion||Targeting Virulence Instead of Viability. Use FimH antagonist to detach virulent bacteria.||2017-07-01|
|David Baltimore||Amgen; MedImmune; ImmuneDesign (like Dynavax); Calimmune (Private); Regulus. Also read about Paul C. Grint current company Apliphi (from $300 to penny on bacteriaPhage nano cap $6M). (20min)||2017-07-01|
|CRISPR Companies||CRSP; NTLA; EDIT; Caribou. All insider selling. Years away from success. TradingView CRISPR index. Other gene editing companies. Cellectis, Sangamo. Everybody is using LNP||2017-07-01|
|DVAX||read about SD-101 in prostate cancer trial. Keytruda approval in any solid tumor with biomarker.||2017-06-30|
|CARA||kapa-opioid receptor inhibitor. Miss endpt.||2017-06-30|
|AGRX||resubmit; no change||2017-06-27|
|DVAX||$IDRA got Orphan designation; $DVAX probably getting Breakthrough Therapy soon.||2017-06-22|
|ABUS||speculation that SGMO raises fund for LNP technology deal from IV board. Ego wrote a great article on LNP IP landscape.||2017-06-20|
|RGLS||1.5h Read Regulus publications, community/charity, work-life, Jay Hagan resume, IR website. Very transparent. Founder CEO Kleanthis Xanthopoulos left June 2015; CMO->CEO left May2017; Refocus. Heavy insider selling from 2012-2015||2017-06-16|
|RGLS||1.5h Read more about RG-012 (miR-21) and miR-17 in kidney disease (JCI paper and Nat. Comm. paper), clinical trials ATHENA and HERA. Its work environment and culture. Competitor miRagen ($MGEN) and Beryllium.||2017-06-15|
|27 companies cash screen||in healthcare with Price/Cash<1 and Debt/Equity<0.2 nothing interesting besides CHMA. so not a useful strategy.||2017-06-15|
|ABUS||learned $ALNY issued new shares last month, pending Patisiran P3 release. Bad results, or company knows it's priced in already?||2017-06-13|
|CHRS||CRL announced. Down %30.||2017-06-12|
|DVAX||NewLink NLNK IDO inhibitor returned by Genentech 90% loss since 2015 high||2017-06-10|
|ACRX||ENDP's Opana ER withdrawal by FDA. 90% loss since 2015 high||2017-06-10|
|DVAX||Leader: Antoni Ribas||2017-06-09|
|DVAX||Steven A. Cohen’s Point72 5% stake. 2.5 mil shares (was in mid 2016 then out in end 2016; now back in)||2017-06-07|
|ACRX||Zalviso was designed with IDEO video. Won reddot award.||2017-06-07|
|ACRX||FDA notified co no longer plans advisory meeting. Heplisav Feuerstein showed 13 out of 16 CRL. Approval cases: Yervoy of BMS, Pomalyst (Celgene), NBIX’s ingrezza. Stocktwits discussion calmed me down. Most were panicking on DVAX history. But this drug is old drug. Small trading volume too.||2017-06-07|
|ACRX||Tim Morris CFO left co. Co. registered $150 mil security shelf.||2017-06-05|
|DVAX||Dynavax announced updated data of 100% ORR at ASCO17. 17% PR and 42% “tumor” shrinkage and SD for PD-1 progressing pct. SD-101 converted cold tumor to PD-L1 expressing hot tumor. May apply for Breakthrough Therapy designation for fast track.||2017-06-02|
|AGRX||CEO Good guy||2017-06-01|
|RGLS||Regulus RGLS, MIRN: reached all time high $22+ with Genentech deal. Now complete restructure at $1. No insider selling though. Chairman Stelius Papaduopolos buying. MIRN just (5.16.2017) reverse merged with Synlogic (a synthetic biotics company). MIRN stockholders owns 17% new company. So Basically Synlogic bought its ticker. Expect MIRN to give up on miRNA pipeline. SYNB1020 is a Synthetic BioticTM medicine designed to remove excess ammonia from the blood. RGLS good candidate. IPO:$4 11.2012; 2PO: $9.5 7.2013; 3PO: $17 11.2014||2017-06-01|
|AKBA||HIF pathway for Erythropoiesis (马宇)||2017-06-01|
|ACRX||read Three Arch now owns 9mil shares; perceptive 5.4 mil||2017-05-31|
|GWPH||After reaching 3.5B market cap three times ($138 peak), seems GWPH has topped and top institutional holders are reducing.||2017-05-31|
|DVAX||Read about ADRO and NVS deal. STING agonist compared to CpG1668 (B type) in presentation; SD-101 is type C. ADRO trial 2 years behind DVAX.||2017-05-27|
|ABUS||Moderna top attorney quits STATNews||2017-05-27|
|Stemina||small private biomarker company with big world leader claim. Not so interesting||2017-05-27|
|ARGX||IPO. ARGX-113 binds FcRn, blocks IgG recycling (including disease causing autoantibodies) and increases IgG clearance||2017-05-18|
|CHRS||Humira patent invalidated.||2017-05-17|
|DVAX||Five >300K increased positions institutional owners. include two million share increases. (Top2: Federated, GMT)||2017-05-13|
|DVAX||Read about CheckMate Pharm., then April updates of Dynavax cancer trial and Asthma trial. Lots of recruiting locations (55 and 12 (14 as of 05.16.17 update)). Much better than Idera and CMP. Go with leader company and doctor.||2017-05-13|
|ABUS||New >5mil position by Ladenburg Thalmann (12.31.16) New 2.7mil by RTW (Top2: QVT and Ladenburg)||2017-05-13|
|ACRX||Saw >2mil shares BlackRock? new position, became 2nd biggest (Revised later). Otherwise institutional owners reducing (Perceptive)||2017-05-13|
|AGRX||Five >300K increase institutional ownership (Top2: ProQuest, InvestorAB)||2017-05-13|
Saw one >200K new institutional owner (3.31) (Top2: MPM(Pharmasset), FMR-Fidelity)
|AGRX||CEO and CCO open market purchase of 63.3k shares and more option execution||2017-05-11|
|DVAX||$IDRA $DVAX have same cash & market cap. But they are NOT the same in TLR9 assets. Which is overvalued and which is undervalued? (149M x $1.84 w. 90~100M cash; 48.8M x $5.6 w. 90M cash)||2017-05-10|
Sold with $5500 (35%) loss. I don’t trust the management. Switch to ABUS 3.34 / AGRX 3.32. If OPK up, all biotech will be up. "This 1Q PR is full of errs, typo, and promoting language such as significant, experienced, substantial etc. Stay away!"
Look beyond the obvious. What is the depressing factor that I see differently with substantial proof? CTP? Rayaldee? 4KScore? GeneDx? No such thesis for OPK. Only the wishful thinking and blind hope in technology.
|DVAX||1q report reveals ATM financing of 48.4million (10mil shares); importance of finance planning for worst scenario||2017-05-08|
|ACRX||Zalviso trial completed 3 months early than planned||2017-05-08|
|AGRX||announce irregular bleeding days results. Twirla actually decreases irregular bleeding||2017-05-06|
|OPK||Financial report full of promoting language and error, flat 4K QonQ and lack of focus. Decide to sell.||2017-05-01|
My Estimate: late 2017/early 2018 initiate trial; late 2020 results; EU trial results 2019.
|DVAX||SA article compares other combos||2017-04-30|
|ACRX||~2h Read about Zalviso EU launch progress Jan17 ppt Apr17 ppt||2017-04-30|
|AGRX||breakout cup-with-handle without news; shorts trying to spill out quick “facts” DrSternbergMD.||2017-04-28|
bottom? at 40% cash value $1.55/shr
|ABUS||5 weeks tight pattern prior to EASL; cohort 3 data not as exciting as expected, no move. -> 8 weeks and counting||2017-04-21|
|AGRX||Thesis Post 3.5 hours||2017-04-09|
|DVAX||AdCom announce too close to PDUFA||2017-04-03|
|ACRX||Indeed came down to test 2.50 support; almost flipped XBI to buy this. Spend 20 minutes to decide not to add more to this position. It is OK if it’s the rock bottom.||2017-04-01|
|RTTR||lactose intolerance Phase II. Disappoint. Small difference. One center skew results. Didn’t buy 1) not enough understanding 2) not at cash value (3X) 3) TA not good.||2017-03-29|
|AGRX||Read 8-K about FDA meeting minutes on UB arbitrary limit; and Trend chart and same drug later study||2017-03-22|
|ABUS||Alexion deal 7.5mil||2017-03-15|
|DVAX||Resubmission accepted. Q2 AdComm, Aug10 PDUFA||2017-02-28|
|DVAX||Add more at 4.10, bring average to ~$12||2017-02-16|
|AGRX||add more on V day after talking to An-Chieh, bring average to $5.85||2017-02-14|
|CHRS||Insider selling is a big warning sign. secondary offering @24||2017-02-07|
|ABUS||Read about Arbutus Acuitus litigation and Moderna||2017-01-15|
|OPK||Claros platform initiated.||2017-01-15|
|AGRX||Three days later: start to read more, Confident comes back. Emotion ebbs.||2017-01-04|
Huge decline in the last trading days prior to data release: to all time low from $8.
My thesis: my best performing pick, above 200ma, holding well during October decline; CORI good; but chart was in trouble shape. No insider selling. Another phase 2 in place.
Emotion: disappointment; negative thinking: career perspective(science vs finance), confidence in relationship, but anxiety relieved; go back to China; responsibility to family, sorry for dad and mom.
|Vanderbilt Cancer Center||Pathways, Anti-cancer agents, Targeted, Immune-oncology etc. New Immu-Onco drugs||2017-01-01|
|OPK||hGH-CTP fails phase 3 in adults loss 20%. Read about competitors : ascendis, versartis. Read about trial results. No efficacy endpoints in adult phase II. Outlier analysis.||2016-12-30|
|OPK||Read about exenatide and liraglutide and glp-1 diabetes drugs. Seems TT401 MOD-6031 in a tough position||2016-12-15|
|ABUS||ARB-1467 more data release. Good. Chardan cites safety flare and ALN-HBV. Down 10%. Read about ALN-HBV. Completely ignored what he said about efficacy. Now attacking on safety and untested ALN-HBV.||2016-12-12|
|DVAX||Cancer R&D day slides promising||2016-12-09|
|ABUS||Arrowhead programs canceled||2016-11-30|
|DVAX||CRL. drop to ~$4 Unexposed risk (cardiac events) Buy cheap. Counter argument. Worst case scenario. if 2nd CRL, no money for HEplisav or pipeline. Bankruptcy possible. TA: trend, 200MA. Evaluate the financial viability aka risk of dilutive fund raising.||2016-11-14|
Trump win. More preliminary 0.5hour. Ref BRAF inh. and T-Vec
|DVAX||Everyone miss the main point: SD-101 oncology. too far away||2016-10-10|
|DVAX||SD-101 preliminary results announced. Stock price no big change. Given 33% ORR, the chance of 3/4 is 8/81, less than 10%.||2016-10-09|
|OPK||4KScore report no cover from Palmetto/Medicare LCD. Novitas MAC||2016-10-07|
Tight Junction Permeable - Growth hormone problem. There are responders. 1st CRL. Get in too early, before seeing bottom. #oraldelivery
4.27.2016 FDA postpone 8.5 FDA AdCom 9.2 FDA Cancel 9.4 Company responds 10.3 Company receives question 10.4 Adam Feurestein: 13 of 15 rejected comment: how many previous AdCom and CRLs? Statistics does not infer causality. Fake statistics.
|ABUS||ARB-1467 release: 1day chaos. Chardan cites efficacy "fail"||2016-09-30|
|OPK||TT401 abandoned by Lilly due to inferoity in reducing HB1Ac||2016-06-30|
|OPK||CMC CRL didn’t matter||2016-03-30|
|OPK||Big drop after BRLI buyout. Should have exit||2015-10-02|
|ACRX||2015.07.24 Zalviso positive CHMP; 09.21 PDLI deal; 09.22 EMA approval||2015-09-22|
|ABUS||Public offering at $20.25||2015-03-01|
|ACRX||Refuse bench testing. Pamela Palmer video https://www.youtube.com/watch?v=X8Js8VfFJ_o||2015-03-01|
|ABUS||Tekmira acquired Oncore||2015-01-12|
|ABUS||Found Oncore; acquired Enantigen and license others||2014-09-01|
|ACRX||CMO Pamela Palmer resume.||2014-07-01|
|DVAX||orignial IPO $7.5 ($75 after rev-split)||2004-02-19|