TicNoteRecorded
VTL

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

2018-09-15
PGNX

met just 1of2 co-primary endpoints in Ph3 of 1404, imaging agent to visualize prostate cancer

2018-09-15
GLPG

$GILD partner Phase 3 filgotinib (JAK1) in adults with moderately-to-severely active rheumatoid arthritis success

2018-09-15
FOLD

pivotal trial required of AT-GAA for Pompe disease, current data insufficient.

2018-09-15
ACOR4 Ampyra patents invalidated; FDA extended PDUFA of Inbrija 3 months to review newly submitted CMC info
2018-09-15
GILDPrecision Bio deal to use its ARCUS homing endonuclease to gene-editing HBV; need LNP to deliver? to boost IPO?
2018-09-12
DVAXnew 52-week low, check insider trading, no severe selling
2018-09-12
ACRX

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]"

2018-09-11
ABUS

Dirk's blog on recent success from $ARWR $DRNA; $DRNA LNP DCR-PH1 not enough knockdown

2018-09-11
ACRX

AdCom 10.12 only with Anesthetic and Analgesic Drug Products, no Drug Safety and Risk Management joint meeting.

2018-09-11
SGMOdid 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
EurekaCAR-T for AFP+ liver cancer worked in 6 patients, 3 died though due to non-drug related complications.
2018-09-10
AGRXpop 100% AH, no PR.
2018-09-10
CRL Rev

$IONS volanesorsen for familial chylomicronemia syndrome on safety issue
$MNK Stannsoporfin heme oxygenase inhibitor for jaundice bilirubin
$AGN ulipristal acetate (Esmya) CRL due to post-marketing safety report outside of US
$INSY buprenorphine sublingual spray for pain
$AKAO FDA approved one and CRLed another indication
$BHC Duobrii for psoriasis old drug combo; FDA needed PK data, resubmitted in 2 months
$SCPH human factors studies, device modifications, and potentially a clinical validation study
$TXMD reversed previous CRL and approved
$REPH IV meloxicam for pain, resubmitted in two months
$EOLS CMC complete response letter for DWP-450 (prabotulinumtoxinA) Botox rival
$LPCN LPCN-1021 low testosterone

All have its own BioLog entry except for $BHC

2018-09-08
HSGXcell therapy for cartilage miss Ph3. Lots of hand waving on website
2018-09-08
PRQR

positive interim data QR-110 for Leber’s congenital amaurosis 10 (LCA10). ADAR RNA editing.

2018-09-08
SGMO

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

2018-09-08
AZN

$AMGN partnered anti-TSLP received FDA BTD; another news

2018-09-08
EYEG

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

2018-09-08
REPH

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

2018-09-08
MNKD

license deal Ph3 dry powder formulation treprostinil, for pulmonary arterial hypertension, to $UTHR, $45M upfront

2018-09-08
ARWR

announce ARO-HBV results, decent results, has nuc naive and eAg+, no patient details. pop +58%, cash low, to offer?
$DRNA released PoC DCR-PHXC for Primary Hyperoxaluria, offering followed
$ABUS flash crash 10% on competition from $ARWR

2018-09-06
DVAX

Checkmate to collaborate with Pfizer/Merck KGaA

2018-09-05
NKTRfill the gap rally seems setting up another gap down after reaching 200MA
2018-09-04
SPHS

Topsalysin, a first-in-class, pore-forming protein, only activated by actitve PSA enzyme found in prostate cancer

2018-09-02
OPNT

Santa Monica based Narcan (naloxone HCl) Nasal Spray for the emergency treatment of opioid overdose

2018-09-02
AFMDNK cell based immunotherapy, deal with Genentech, up 247%
2018-09-02
DVAXRibas and Levy, respectively, published stories of Ph1b Melanoma and Lymphoma SD-101 on Cancer Discovery (IF: 24)
2018-08-28
IONS

FDA rejects volanesorsen for familial chylomicronemia syndrome on safety issue #CRL

2018-08-27
ALNYrelief rally 16% on Tafamidis ATTR-CM soso data released. Tafamidis already approved for FAP. Will compete.
2018-08-27
MGENmiRagen 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
KALA

Inveltys (corticosteroid) approved for post-operative inflammation and pain post ocular surgery. No price move.

2018-08-26
AGN

ulipristal acetate (Esmya) CRL due to post-marketing safety report outside of US

2018-08-26
MNKStannsoporfin CRL received post 3-21 AdCom
2018-08-26
GERN

Up 29% $JNJ advertise for Strategic Pricing Manager for Imbruvica and Imetelstat. due whether continue Imetelstat program

2018-08-26
EXAS

Cologuard non-invasive stool DNA screening test for colorectal cancer; co-promote deal with $PFE

2018-08-26
AZN

Hit by surprise setback, AstraZeneca scrambles to explain why its two-in-one COPD inhaler was beaten by GSK rival

2018-08-23
BPMCISEH Nick Lydon talk, all three Lasker winners for Gleevac are scientific founders of $BPMC
2018-08-23
DVAXmologen subQ CpG lefitolimod failed as SCLC monotherapy after PR for platinium chemo. show MOA.
2018-08-21
DVAXfairvalueforyou 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
ADMP

$TEVA Epipen generic approved. commercial launch of $ADMP at the discretion Novartis' Sandoz. Poor stock

2018-08-18
MRK

Lenvima (lenvatinib) kinase inhibitor for hepatocellular carcinoma (HCC).

2018-08-18
VRTX

Kalydeco (ivacaftor) CFTR potentiator for cystic fibrosis. extended  to infants.

2018-08-18
DVAX$IDRA to focus its resources on TLR9 after merger fail, give up rare disease, uses 8mg
2018-08-16
ABUSPfizer invest in BioNTech's mRNA vaccine while Genevant deal was about rare disease and oncology
2018-08-15
DVAX

wrote about AZD1419 trial withdrawal speculation, no impact on twitter
08/19 posted to IV, 08/20 someone shared to Yahoo and StockTwits.com, traffic spike.

2018-08-15
Moderna

Moderna’s Billions: Will Building Big Before an IPO Pay Off?

2018-08-13
DVAXasthma loss of control references: 1, 2, 3, 4, 5
2018-08-13
ALNYsell 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
SGMO

CSPR tout 60% quadruple KO and CART but no off-target mention;  file LNP patent application; against $ABUS

2018-08-12
ABUSread 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
DVAXread bashers on SA, doubting Heplisav B market potential, post marketing plan, SD-101 no partner, loan term milestones, CDC order
2018-08-12
modalityCelebrating new therapeutic modalities by Robert Plenge CWRU MD/PhD
2018-08-12
ACRX

Palmer (as well as CEO, CFO) bought a total of 37,000 (total 57,300) shares at $2.75-2.89 open market

2018-08-12
Hygiene

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

2018-08-11
SBBP

acquired Macrilen from $AEZS; RECORLEV (levoketoconazole) for Endogenous Cushing's syndrome Ph3 success

2018-08-11
medicine

Is modern medicine weakening the human race genetically?

2018-08-11
BLPH

INOpulse, inhaled nitric oxide to respiratory system in pulses, failed pulmonary arterial hypertension (PAH)

2018-08-11
OVID

GABAA receptor agonist for rare Angelman syndrome. Neurology drug, efficacy doubtful. No current treatment.

2018-08-11
GEMP

terminated its Ph2a trial of gemcabene in pediatric patients with non-alcoholic fatty liver disease (NAFLD) -45%

2018-08-11
ACRX$PTIE Remoxy CRL follow previous 3-14 adcom vote
2018-08-11
Parents

Realities of Rare Disease and the Role of Patient Investors [globalgenes.org]
Parents of Children With Rare Diseases Find Hope in For-Profit Companies [NYT]

2018-08-11
FOLD

Galafold Migalastat for Fabry disease inhibitor of mutant α-GalA as pharmacological chaperones. Once demanded more data, reversed, now Approved. John Crowley

2018-08-11
TXMD

Annovera (Segesterone Acetate/EE Vaginal Ring) approved after previous vaginal pain CRL reversal. no SP change. $AGRX

2018-08-11
LJPC

Giapreza angiotensin II for IV early sales fall short of expectation?

2018-08-11
ENDPdown >90% following aggressive acquisitions and Opana ER withdrawal, turn around coming? Not interested
2018-08-11
ONCE

SPK-8011 for Hemophilia A sees immune response, variable outcome, ALT flare, push for PhIII. LNP better?

2018-08-11
MNK

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)

2018-08-11
ABUS$SGMO IV AAV v. LNP discussion
2018-08-11
PTGX

PTG-100 discontinued due to CRO error. Raise $22M To revive. α4β7 integrin antagonist peptide for ulcerative colitis

2018-08-11
DVAX

$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

2018-08-10
CHMA+40% $1.25 to $1.75 on >10X volume spike after Q2 updates and making all time low.
2018-08-10
DVAX

speculation on AZD1419 trial withdrawal design suggests positive results, IV post, my response on 28th to 24th change

2018-08-10
ALNY

first RNAi drug Onpattro (patisiran) approved by FDA 16 years 2.35B loss by Alnylam. Endpts news. $ABUS no change. Andy Pollack 2011.02.07 Piece

2018-08-10
NKTR$IONS both see technical recovery, potential uptrend again? NKTR moving forward with 214 216 PhIII planned
2018-08-09
ALNY7 death in patisiran arm all cardiac death, not drug related
2018-08-08
ACRXoffering option exercised in full
2018-08-08
DVAXER 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
PGNX

AZEDRA® (iobenguane I 131) for rare tumor radioactive therapy for rare tumors

2018-08-04
EPZM

EZH2 inhibitor tazemetostat failed another indication DLBCL

2018-08-04
NBIXIngrezza exceed estimates again
2018-08-04
BPMC

Blueprint, company focus on kinases. avapritinib Kit PDGFRa inhibitor for GIST to submit NDA

2018-08-04
MNKDcontinue to fail commercial decline 98% from high
2018-08-04
TSROPARP inhibitor continue to miss revenue, price decline almost 90% from high
2018-08-04
ACRXCC talked about AdCom topics REMS , IV morphine shortage accelerating P&T committee approval, commercial plan
2018-08-03
ABUSYesterday breakout was fake, down -20% after ER. CC talked about trial design, MOAs and Combo
2018-08-03
ABUS

break out sideway bullish flag. People who quit to "avoid the down again" or lock in "profit" miss the bus

2018-08-02
IDRAReverse split 1:8
2018-08-01
ACRXjoin anesthesia and risk management AdCom meeting Aug 3 announce only 3 weeks earlier on July 11
2018-08-01
INSY

Small cap. CRL on buprenorphine sublingual spray as a treatment for moderate-to-severe acute pain

2018-07-28
TNXP

nano cap, Tonmya inhibits serotonin2a R, alpha-1 adrenergic receptor, histamine-1 receptor. Failed PTSD PhIII

2018-07-28
CRMD

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.

2018-07-28
TORC

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"

2018-07-28
ACORsole MS drug Ampyra patent expire. Attempt to block generic entry fails
2018-07-28
GSKNucala Mepolizumab anti-IL5 failed AdCom 3-16 for COPD
2018-07-28
BIIBBAN2401 results has catch, APOe4 imbalance. Company pushing for accelerated approval
2018-07-28
RETA

Positive PhII Data for Bardoxolone Methyl in CKD Caused by Alport Syndrome and ADPKD $RGLS competitor

2018-07-28
CHMAMPowered trial complete enrollment expect data Early 2020 for EU submission
2018-07-26
AGRXdispute 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
ABUSLNP vs GalNac MOA: fast and transient vs slow and stable. Combo's best. Competitor has no option.
2018-07-23
PTCT

acquired AAV DNA gene therapy company Agilis (National Taiwan University ) for CNS disease Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency $50 + $150 stock

2018-07-21
CTIC

Flt3 JAK2 dual inhibitor Pacritinib FDA requires PhIII trial

2018-07-21
CHRS

expect CHMP positive opinion for pegfilgrastim biosimilar candidate CHS-1701

2018-07-21
AVEOTivozanib delayed for 1Q to Q4 18
2018-07-21
MRSN

Dolaflexin (polymer Vedotin (auristatin)) ADC targeting Her2 or NaPi2b. Clinical hold. Jun 2017 IPO

2018-07-21
ABUS#TA chart either a double top or about to break out
2018-07-20
ACRXearly August AdCom no $ACRX, now most like mid September to early October
2018-07-19
DVAXshorts waving VBIV, may come 2020, 3 dose, that's why no partner? DVAX future is IO and Immune-modulatory TLR
2018-07-18
DVAXJimmy Cramer pumped Dynavax again, given no reason.
2018-07-17
ABUSlook at minute chart, does not see a short term top $ACRX strong base on base $DVAX $AGRX neutral
2018-07-15
RoivantUrovant goes IPO raise $150M $UROV
2018-07-15
ADXS

axalimogene filolisbac attenuated Listeria with antigen-adjuvant fusion protein for Immuno-oncology FDA lifted clinical hold

2018-07-14
CTIC

Pixuvri Rituximab combo fail. Pixuvri is anthracyclines without cardiotoxicity

2018-07-14
XLRN

Luspatercept for RBC maturation, success with b-thalassemia pts after MDS 2 weeks ago. No significant price change.

2018-07-14
IDRA

BioCryst $BCRX shareholders rejected merger offer. IMO-2125 now called tilsotolimod

2018-07-14
ZGNX

ZX-008 Fenfluramine PhIII success. reduction in monthly convulsive seizures was 62.7%

2018-07-14
Timingmissing best and worst 25 days beats buy-and-hold, but doable or not? Focus on Buffett rules and the company
2018-07-12
ABUSlots 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
ACRXoffering priced $2.75 raised $20mil. Close -13% $2.95 purpose?: to buy time for buyout
2018-07-12
GWPHapproved on 6.25.2018
2018-07-11
ABUSshort interests rose from 0.8mil to 2.8mil at Jun29 cut off vs Jun15. at price $6.35-7.30
2018-07-11
ACRX

Raise money. Perhaps no EU partnership. Company is more attractive to a larger company with full global rights for buyout.

2018-07-11
ABUSBreak 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
ABUS

watch Roivant day reply.

  • Roivant model: significant unmet need with underserved R&D
  • Not just misplaced drug candidates, but also platform technology such as LNP
  • More color on ABUS pipeline and strategy
  • Combo strategy, timeline and trial design
  • Capsid inhibitor landscape
  • AB-1467 may not be important
  • AB-452 RNA stabilizer has 2nd gen follow up
  • Aware of many companies using LNP like tech, more deal to come
2018-07-11
ABUS
  • AB-506 Capsid dosed first patient
  • AB-452 filing in Q3, Q4 dosing
  • ARB-1467 interim 6wk combo data due Q4
  • "transformative" deal with mRNA leader BioNTech to co-develop rare diseases and license LNP for oncology targets
2018-07-10
AXON

license from Benitec BB-301 for Treatment of Oculopharyngeal Muscular Dystrophy and Broad Platform Collaboration

2018-07-09
DVAXDV281 preclinical study published at Cancer Research. June 2018 PPT presentation explicitly show combo without anti PD-1
2018-07-08
RGLSCMO was fired due to restructuring
2018-07-08
ACRXOpioid 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
Top60
  • TIG: Tigenix Belgium Adipose-derived stem cells for Fistulas. Allogenic CSC in pipeline
  • SRPT: 2y 10x due to DMD and gene therapy success low $3.3
  • IMMU: immunomedics long time mediocre, 18m 10x run due to ADC low $1.7
  • ACAD: peak $50 2015, run 3 times to $40 now downtrend due to safety concern. 3y 30X low $0.7
  • SGEN: 15y 30x low $2.3
  • JAZZ: amazing 300x run 2009-2015 low $0.7
  • NBIX: 8y 50x 4y 10x low $2.1
  • I had systemic analysis of lows, don't waste time doing manual. Re: studied in IPO premium of indice components. Here I am looking at high fliers. So good vindication.
2018-07-08
ADMPSymjepi, Mylan Epipen competitor, epinephrine PFS, sign deal w. Sandoz. Still low MCap. lots of CRLs, mediocre long time
2018-07-07
DVAXAZD1419 PhIIa updated a 4-day diff for completion.
2018-07-06
BIIB

BAN2401, an anti-amyloid beta protofibril antibody for early Alzheimer's disease, PhII results significant. +20%

2018-07-06
ABUS

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

2018-07-06
RGLSrestructure: 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
ABUS

Found WHO/NIH PPT in DNA and mRNA vaccines. CureVac, GSK uses LNP. Gritstone/ALNY/SGMO/CRSP/NTLA/Generation Bio/Moderna/RGLS/CureVac/GSK

2018-07-04
ACRX

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.

2018-07-03
ABUS

preliminary response posted. Argument is strong and clear with lots of figures to compare the '069 and '127 patents.

2018-07-02
ACRXAdcom maybe early August mid September. announce 1m prior. Different AdCom has different logistics. See DVAX
2018-07-02
MACK

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

2018-06-30
AKAOFDA approved one and CRLed another indication, just as AdCom voted.
2018-06-30
AQXP

Aquinox Rosiptor activator SHIP1 to regulate PI3K. PhIII failure interstitial cystitis/bladder pain syndrome. 2015 IPO down big. Just signed $25m with Astellas

2018-06-30
GBTVoxelotor 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
SMMT

Oxford spinout. No focus: antibiotic + DMD utrophin mod, which just failed. Sincere letter to community. 2016 IPO down big

2018-06-30
ASNSuse 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
GEMPfirst in class to lower VLDL and inhibit cholesterol and triglyceride. PhIIb Success for statin failed pts. 2016 IPO, micro cap, competition?
2018-06-30
XLRN

Acceleron in 20-50 range forever. First in class TGF-b platform. Lead Luspatercept for RBC maturation, success with MDS pts

2018-06-30
DVAXassembles 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
ABUSabout to break above weekly 200MA, first time since 2015, showing strong relative strength
2018-06-27
ACRX

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
2018-06-27
Roivant

reorganize layoff and shift people to subsidiaries. $ABUS William Symonds become CEO of new Altavant on pulmonary arterial hypertension

2018-06-26
CBIO

Factor IX protease, CB 2679d aka ISU304, noted the presence of a neutralizing antibodies in patients' blood.

2018-06-25
PTCT

PhI of risdiplam RG7916 modifying the splicing of the SMN2 to generate more full-length SMN mRNA in SMA patients

2018-06-25
OBSV

OBE2109, a gonadotropin-releasing hormone (GnRH) receptor antagonist with less bone loss side effect

2018-06-25
Daiichi

Flt3-ITD inhibitor quizartinib to file NDA for AML

2018-06-25
Kallyopedeal with Novo to discovery gut-brain axis on metabolism drugs.
2018-06-25
DVAXpresented at diabetes meeting on post hoc analysis of diabetic cohort ~90% vs 60%
2018-06-25
ACRXCHMP April -> EMSA approval PR date 6.23-7.7 mostly 6.27,28,...30.
2018-06-24
SRPTearly success in DMD gene therapy
2018-06-20
ACRXNew corporate slides highlight the other opioid crisis - opioid shortage due to manufacture problem. Also mentioned in CC. Zalviso EU sales new high in March2018-06-18
NVS

canakinumab anti-IL1b reduce gout besides previously announced cardio

2018-06-16
VIIVHIV two drug regime to replace Gilead 3 drug regime
2018-06-16
NITE

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.

2018-06-16
CELG

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

2018-06-16
antibiotics

FDA, like software, having hospitals buy licenses to antibiotics instead of reimbursing on a per-use basis. #pricing

2018-06-16
SCPH

CRL after letter of deficiencies: human factors studies, device modifications, and potentially a clinical validation study

2018-06-16
VTVTpart B confirmed failure. Still pinning hope on subgroup analysis
2018-06-16
Y+500%

Healthcare MDGL MRTX VKTX ECYT CERC TRXC QURE ARWR CASI took 6m-2y to form a flat base

  • CASI: mediocre for decades, recently to focus on generics for China. Pop due to CFDA reform. Fishy Chinese concept
  • *ARWR: down to <$2 in ARC-520 disaster. Recovered with other pipeline and RNAi hopes
  • *QURE: gene therapy, continue to rise 100% after PhII success in 2017.10 (see log) was at bottom with Bio bear
  • **TRXC: Digital laparoscopy surgical system, Rejection 2016.04, offering 2017.04 lowest $, Approval 2017.10
  • CERC: pipeline failure in 2016.12, merged with TRx to change focus, mediocre
  • ECYT: mediocre company revive within-licensefrom Germany, see previous log
  • *VKTX: metabolic disease, rise with MDGL success, same MOA
  • **MRTX: first-in-class KRAS inhibitor + PD1 combo, MET inhi. disappoints in 2016 ASCO, 5x in 9m *after* KRAS data
  • **MDGL: NASH success
2018-06-16
GLMD

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.

2018-06-16
MDGLexploring sale of company
2018-06-16
SAGEFDA allows only One pivotal trial for SAGE-217 for MDD and PPD; $575M ($90M up) japan deal
2018-06-16
Parker

Parker Institute brings together the world’s brightest minds to push the boundaries in cancer immunotherapy research

2018-06-15
CHMAOPTIMAL trial 50% randomized. On track to complete enrollment by YE2018 and top-line data Q4 2019
2018-06-14
ABUSAdded to Russell 3000. Volume pickup in tight trades
2018-06-14
DVAX

Checkmate AACR report on turning cold tumor into hot. Historical opinions.

2018-06-13
DVAXtalked to poster at I3T on PD-1 neoadjuvant therapy
2018-06-13
AXON

licensed rights to OXB-102 (AXO-Lenti-PD), a gene therapy for Parkinson’s disease. up 150% to $4.80.

2018-06-11
DCPH

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.

2018-06-11
GILDdeal with Hookipa on HIV and HBV, using LCMV vector to delivery non-replicating strong immune response
2018-06-07
AGRX

 submitted a formal dispute resolution request (FDRR) 2 month (1m meeting 1m decision) turn over, workforce reduction, cash to 2Q2019

2018-06-07
ABUSNew CFO was Incyte's original CFO from 2003-2014
2018-06-07
DVAX

Why 2mg works better? Higher dose CpG does not mean higher IFN response. High dose actually inhibits IFN response.

2018-06-05
DVAX

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.

2018-06-04
DVAX

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%

2018-06-04
NKTRFlemming two-stage design. 2nd stage data underwhelm
2018-06-04
ASCO

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

2018-06-02
TXMDFDA reverse CRL under new commissioner Gottlieb Politics?
2018-06-02
SNDXEntinostat HDAC inhibitor to combine with $NKTR NKTR-214 IL-2 receptor
2018-06-02
LLY

baricitinib (Olumiant) approved 2mg; 4mg limited to TNF resistant ones $INCY

2018-06-02
SCPH

sc2Wear® Infusor, subcutaneous delivery of infused therapies. FDA issue letter of deficiencies

2018-06-02
MDGLachieved PhII liver biopsy endpoint, $16 -> $280 in 9 months $VKTX also soar same MOA
2018-06-02
CLSDmarket overreacted to new results. Intraocular pressure IOP is fine if not chronic. RVO results was great.
2018-06-02
analyst eventhas 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, $DVAX
2018-06-01
Antibodybroad patent no longer allowed; need to be specific. Retroactive
2018-06-01
ABUSNew USPTO chief Andrei Lancu may favor patent owner
2018-06-01
CLSDphase II numerically worse than Eylea, but not significant. I think overreact since CLSD require less dosing.
2018-05-31
AZNfailed another Fasenra COPD expansion. really need better respiratory franchise.
2018-05-31
ABUSModerna challenge, preliminary response due 6.15, board decision due 9.15
2018-05-30
BioLogFirst period after launch 3.10 - 5.18.2018 daily record; take too much time too much noise (Taleb Black Swan information and knowledge) Go back to weekly top news and BopPharmaCatalyst
2018-05-29
DVAX200k share sold by multiple officers in march 2018
2018-05-26
13Fnothing significant; AGRX increased; QVT sold
2018-05-26
ACRXNDA accepted PDUFA 11.3.2018 1 year delay
2018-05-24
ACRXThree Arch's 9mil shares reached term; acquired by Leerink partners in private transaction. Confidence
2018-05-23
DVAX$MRK NSCLC chemo-PD1 combo success, raise the bar for DV-281?
2018-05-23
DVAXTLR7 viral IFN induction is impaired in Asthma. TLR9 same fate? IFN reverse Th2 in human
2018-05-22
DVAX

#ASCO18 SD-101 has much less AEs than lenvatinib. Chemo or cetuximab + PD-1 combo results not available for preview.

2018-05-19
DVAX

#ASCO18 HNSCC PD-1 combo peers: T-Vec 16.7% (6/36) lenvatinib 36.4% (8/22) $DVAX SD-101 33% (6/18; AACR)

2018-05-18
DVAX

AZD1419 first-in-human study published. Previous 1018 publication 2006

2018-05-18
SNDXEntinostat HDAC inhibitor poor results post hoc in monocytes high patients
2018-05-18
AGRXType A meeting minutes requested reformulation, bioequivalence, new phIII trial. Decide to appeal. 80% accept 16% granted
2018-05-18
AMGNfirst-in-class Aimovig (erenumab) $NVS anti-CGRPR antibody approved by FDA $6,900/year
2018-05-17
NVOstem cell therapy to cure diabetes
2018-05-17
ACRX

FDA approves first non-opioid to treat withdrawal symptoms in adults

2018-05-17
ASCO

$LOXO RET-fusion inhibitor biggest winner competitor $BPMC not so
$NKTR ORR drop MEL 63%(11)->52%(23)
$JNCE ICOS activating ab no luck in gastric or triple negative breast cancer
$MRK lots of its own pipeline presentation, no potential partnership

2018-05-17
DVAXSell off after ASCO abstract release 60% ORR Gap close. Gap fill order filled 157 shares $2.5k @$16.50
2018-05-17
PFEEpogen biosimilar approved (Retacrit) after 3 years of struggle
2018-05-16
FogPharma

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.

2018-05-16
EOLS

CMC complete response letter for DWP-450 (prabotulinumtoxinA) Botox rival

2018-05-16
DVAXASCO abstract release 60% ORR per protocol 15/25, another 5 non-evaluable. NKTR-214 52% per protocol
2018-05-16
ACRXBreakout above 200ma on big volume and break even on my investment2018-05-15
Celsius

new tech in genetic sequencing machine learning algorithm precision meds for cancer and autoimmune disease.

2018-05-15
LLY

$AMGN $NVS Lilly's galcanezumab fell behind erenumab

2018-05-15
Polyphor

murepavadin against Pseudomonas aeruginosa and anti-CXCR4 drug balixafortide oncology

2018-05-15
XenikosT-Guard targeting CD3 and CD7 for GVHD
2018-05-15
CellCentric

UK-based CellCentric’s CCS1477 p300/CBP inhibitor through Phase IIb in prostate cancer

2018-05-15
MEIP

PI3K inhibitor for a common non-Hodgkin lymphoma

2018-05-14
LLYbought back Aurora kinase A inhibitor it shed in 2016
2018-05-14
Beam

David Liu, now-serial entrepreneur Feng Zhang, and J Keith Joung using CRISPR to rewrite bases not cut

2018-05-14
CHMA

FDA Agreement to Redefine Certain Secondary Endpoints in CHIASMA OPTIMAL PhIII trial

2018-05-14
SURFCD47 overexpress on tumor cells to prevent macrophage phagocytosis
2018-05-14
MRK

$PFE automatic synthesis 默沙东 辉瑞 高通量自动化反应筛选的"军备竞赛"

2018-05-13
DVAXbrief <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
CLDXcut 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
AZN

Push benralizumab antiIL5R failed in a COPD trial. $GSK Nucala Mepolizumab was first-in-class

2018-05-11
BiotechTrump speak on drug pricing, lots of promise, no tough measure. Endpts.com opinion on high healthcare cost
2018-05-11
Semma

implantable, credit card-sized device containing these beta cells that would do the work of a healthy pancreas

2018-05-10
VTVT

post hoc analysis of the failed first round of Phase III data

2018-05-10
PRVB

Eight years after Eli Lilly dumped it, Provention Bio bring teplizumab a IPO to back a PhIII diabetic comeback

2018-05-10
LLY

Acquired $ARMO for pegilodecakin, a PEGylated IL-10 immuno-oncology

2018-05-10
EVLO

new microbiome IPO "monoclonal microbials"

2018-05-10
Escient

Ex-Receptos CTO Marcus Boehm found new startup for Mas related GPCR

2018-05-10
LodoMetagenomics from soil bacteria for drug discovery
2018-05-10
ACRX

Add 1493 shares ($3.7k)@2.50 Abandon LABU (time decay is annoying)

2018-05-10
ABUSAdd 655 shares ($4k)@$6.10 Abandon LABU (time decay is annoying)
2018-05-10
DVAXAdd 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
ABUSAdd 421 shares ($2.6k)@$6.15 upon breakout cup-with-handle pattern
2018-05-08
Daiichi

quizartinib first Flt3 inhibitor for AML. $410 million buyout of San Diego-based Ambit Biosciences in 2014

2018-05-08
Autolus

utilizes rapamycin activated Caspase 9, a cell therapy safety switch to selective elimination of programmed T cells

2018-05-08
Ascletisfirst HKEX pre-revenue IPO. ex-GSK Wu JInzi. HCV leads
2018-05-08
Luye

绿叶制药 bought $AZN Seroquel regional rights for $538mil

2018-05-08
BHC

$VRX Valeant changed name to Bausch Health Companies with Bausch & Lomb

2018-05-08
ALNY

diving into CNS diseases RNAi into the brain and spinal cord area using intrathecal injection amid Amyloid beta failures

2018-05-08
IONS

$ALNY $AKCA FDA Briefing doc highlighted volanesorsen bleeding risk (55% below 10^5/ul vs none in control)

2018-05-08
ASLN

Singapore’s Aslan tanks on Nasdaq debut, raising $42M in IPO (half of expected) biliary tract cancer. Weak IPO.

2018-05-07
JNJ

Esketamine hit and miss in first pivotal trials of hard-to-treat depression

2018-05-07
ATRA

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

2018-05-07
Biotechfear over drug price controls from administration. Trump to speak. Endpts call "boiling point". Hemo gene therapy $1.5mil?
2018-05-07
SRPT

Sarepta’s eteplirsen spurned as European regulators turn thumbs down on controversial Duchenne MD drug

2018-05-04
PTLA

andexanet alfa approved via accelerated approval pathway; post-marketing trial needed

2018-05-04
CELG

this metabolite of Ozanimod is ~90% of AUC in humans… this metabolite is effectively the drug

2018-05-04
MNK

Stannsoporfin is a heme oxygenase inhibitor for jaundice bilirubin. 3-21 AdCom

2018-05-04
AKAOAdCom split on two indications for this new antibiotic
2018-05-04
ALNY

FDA allow lumasiran in the ultra-rare primary hyperoxaluria type 1 (PH1) using surrogate biomarker urinary oxalate

2018-05-04
CasmaAutophagy for neuro disease
2018-05-04
ABUSModerna challenging ABUS '127 '435 patent, claim same old patent repackaging
2018-05-03
TSLA

Elon Musk Rejects ‘Boring, Bonehead Questions,’ from analysts

2018-05-03
ABUSModerna/Merck targeting KRAS with mRNA but denies ABUS' IP
2018-05-03
JNJJanssen bought oncolytic virus company BeneVir
2018-05-02
ESPR

bempedoic acid lukewarm efficacy, safety concern, low price position

2018-05-02
Refugemutated Cas9 as TF to turn on genes
2018-05-02
ABUSMany abstract using LNP for gene editing delivery at ASGCT 2018, such as Bluebird
2018-05-02
ABUSGenevant website online
2018-05-01
KPTI

multiple myeloma patients who had proved resistant to a long slate of drugs, 25.4% ORR

2018-05-01
Verily

Gilead Immunoscope combines laboratory phenotyping and computational analysis to profile the immune system.

2018-05-01
Attenua

oral neuronal nicotinic receptor (NNR) assets for cough

2018-05-01
4DMTRoche partnership gene therapy AAV platform
2018-05-01
INCYdump multiple programs with $BMY $MRK $AZN
2018-05-01
CrescendoHumabody Vh small size, 1/4 Fab, 38kd for trispecific, rapid penetration in tumor and clear in circulation. Easy design.
2018-05-01
AGNIL-17 for psoriasis discontinued.
2018-05-01
SynthorxSynthetic Biology expanded genetic code to 172 AAs. Lead IL-2 without side effects. OrbiMed
2018-04-30
ALXN

ALXN1210, a long-acting form of its drug Soliris Q8W vs Q2W

2018-04-28
AGRXreleased adhesion and wearability profile at ACOG. But no correlation with efficacy
2018-04-27
ACRXpositive CHMP opinion. up 6.5%
2018-04-27
MammothJennifer Douhna using CRISPR for cancer/rare mutation diagnosis. Remember the paper.
2018-04-27
Innovent

信达生物 Innovent Biologics has a full pipeline of antibody biosimilars

2018-04-27
Senti

SUPRA CAR-T require 2 signal to activate and an on-off switch to control side effects. Wilson Wong, Timothy Lu, Jim Collins

2018-04-27
AGN

ubrogepant, oral calcitonin gene-related peptide (CGRP) receptor antagonist, PhIII results, NDA in 2019

2018-04-27
VRTX

FDA requires more dose-ranging trial before move into Phase III for Cystic Fibrosis CF. Also competitor Galapagos $GLPG.

2018-04-27
CELGCelgene refuse-to-file was due to newly identified active metabolite. still rise 3%
2018-04-26
ACADtanks after CNN reports FDA safety investigation
2018-04-25
NVS

FocalView, an app to track disease progression in patients with ophthalmic disease real-time.

2018-04-25
ADC TheraADC targeting Her2 discontinued due to poor safety at high dose and low efficacy at lower dose. After $200mil financing
2018-04-25
RallyBio

Former Alexion team purged by Ludwig Hantson came together for a startup.

2018-04-25
ACRXon April 23-26 CHMP agenda. Share price is quiet. News expected Friday morning.
2018-04-25
ABUS

Genevant Chairman appointed Clarus partner. sdfad. LNP steroids safety further validated.

2018-04-25
EPZM

EZH2 inhibitor tazemetostat on clinical hold for a pediatric case of secondary T-cell lymphoma.

2018-04-24
OREX

Bankrupted and sold for $75mil to Nalpropion. Contrave maker commercial failure

2018-04-24
Revolution

nature’s selection of molecules to bind to targets that couldn’t be bound to synthetically. anti-fungal to SHP2 PTP inhibitors

2018-04-24
Cedillaprotein degradation using small molecules, focusing on oncology
2018-04-24
LLY

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.

2018-04-24
RHHBY

Pharma Research and Early Development (pRED), Genentech Research and Early Development (gRED), Chugai in Japan

2018-04-24
DRNADicerna hired Merck RNAi scientists when Merck sold RNAi assets to Alnylam. IP lawsuit now resolved with cash and equity
2018-04-23
AVXSdeal history and details. confident and patient, bids from three companies.
2018-04-23
PRTA

antibody drug company, but couldn't find their unique edge. Failed PhIIb PhIII for AL amyloidosis.

2018-04-23
CLDX

glembatumumab vedotin ADC that targets gpNMB compared to Xeloda in triple-negative breast cancers failed PFS

2018-04-22
RARE

FDA approved Ultragenyx's Crysvita for X-linked hypophosphatemia (XLH) in adult and pediatric

2018-04-22
RIGL

FDA approved Tavalissetm (fostamatinib) for chronic immune thrombocytopenia (ITP)

2018-04-22
ARGSArgos individualized DC immunotherapy. PhIII discontinue. Delist from NASDAQ
2018-04-22
GWPHAdcom positive
2018-04-22
BLUE

Bluebird’s gene therapy for beta-thalassemia falls short of a cure, but still wows in 22 patients

2018-04-19
BenevolentAI

an AI “brain” holds “50 billion biological data points and complex biological concepts – the world’s largest

2018-04-19
AZN

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.

2018-04-19
FCSCFibrocell fibroblast cell gene therapy waving white flag and looking for reverse merger
2018-04-18
ACRX

publication in Anesthesiology - the best journal in the field

2018-04-18
NLNKscrape its IDO program in light of $INCY 's IDO1 failure. Evaluating strategy.
2018-04-17
GWPHFDA briefing doc positive. Up 11%. Also citing manageable liver issue
2018-04-17
Checkmate

69 enrollments as a late comer. Great execution by Checkmate. $DVAX is falling behind, despite an early start

2018-04-17
CheckmateArt Krieg's Checkmate CMP-001 oral presentation in reverse PD-1 resistence
2018-04-16
IDRAget funding to expand IMO-2185 into more trials. still down with others $DVAX
2018-04-16
ALKSFDA reverse refuse to file
2018-04-16
Evelo

monoclonal microbial to modulate immune system for cancer and inflammatory diseases. #IPO #microbiome

2018-04-16
DVAX

filed confidential treatment request on a bunch of commercial deals with 3rd party suppliers detailed in 10K. No buyout

2018-04-16
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
ACRX

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。

2018-04-16
AXON

David Hung wipes Axovant from his work history

2018-04-14
DVAXAbstract embargo lifted 40% ORR (4PR) in 10 pts vs historical 13-16% PD1 mono. Melanoma 88% 12m PFS 89% 12m OS
2018-04-14
SPPI

poziotinib inhibits EGFR, HER2/neu, and Her 4 covalently. 11 NSCLC 64% ORR.

2018-04-14
MNLO

Serlopitant, NK1-R antagonist. for pruritus in atopic dermatitis (AD) did not meet. Also for cough.

2018-04-14
ILMNFDA releases NGS and oncology diagnostic guidelines
2018-04-13
ABUS

Speculation: MM retires, new CEO with ID experience and Genevant/3rd party deals for IPO. Replicor PPT

2018-04-12
Enterprise

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

2018-04-12
TessaVirus specific T cell for virus related cancer. EBV, HPV, and two CAR-Ts
2018-04-12
ABUSpreclinical combo data release for 2 gen AB-506, RNA inhibitor AB-452, GalNac AB-729 at EASL2018. No immediate impact.
2018-04-12
ABUS

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.

2018-04-11
ARWRrelease 9 patients ARC-520 data w. ETV at EASL2018. Not impressive. $ABUS
2018-04-11
CLVS

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.

2018-04-11
AMGNexpands Rhode Island previous Immunex manufacture facility with flexible modular design
2018-04-11
ALXNbuyout Wilson Therapeutics $855mil for WTX101, binds to copper and albumin to clear Cu in Wilson disease.
2018-04-11
VTVTanother Alzheimer failure with discarded drug. Worse than placebo. Down 94% from IPO.
2018-04-10
Constellation

#epigenetics CPI-1205 blocks Enhancer of Zeste Homolog 2 (EZH2), over-expressed or mutated in many cancers

2018-04-09
Magenta

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

2018-04-09
MRKsucceed PD-L1 >=1% NSCLC PhIII trial. Previous $BMY fail. Better trial design
2018-04-09
AVXS

Avexis spinal muscular atrophy #genetherapy buyout by $NVS. 10X 2y IPO. Chairman Dan Welch was CEO of Intermune

2018-04-09
NKTR

#DVAX competitor. impressed by NKTR-262 TLR7/8 NKTR-214 combo preclinical data SITC2017 WPC2017

2018-04-08
MRK

acquired a RIG-I company RIGONTEC in 09.2017; 2018 AACR includes a STING agonist MK-1454 and SD-101 stuides

2018-04-07
SRPT

Sarepta’s patents be seized by government? Patient advocates pitch controversial drug pricing proposal. $300k

2018-04-06
UBX

Unity Biotech. IPO ridding bodies of senescent cells for ageing.

2018-04-06
Celltrion

the warning letter, FDA observed “multiple poor aseptic practices”, hence CRLs for Rituxan, Herceptin biosimilars

2018-04-06
IDRA

BioCryst and Idera to Merge to Serve More Patients with Rare Diseases

2018-04-06
INCY

$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"

2018-04-06
CNAT

NASH PhIIb trial failure. No difference. some encouragement in subgroup analysis for advanced fibrosis and early cirrhosis.

2018-04-05
Boehringer

the only drug targeting SIRP-alpha and preventing CD47 from binding to it.

2018-04-05
Ferring

bought microbiome C. difficile drug RBX-2660 from ReBiotix. leadership in gastroenterology and microbiome $MCRB

2018-04-05
TernsWeidong 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
Poseida

autologous T cell and NK cell therapies. P-BCMA-101 for multiple myeloma

2018-04-04
Terns

Weidong Zhong. In licensing Eli Lilly, farnesoid X receptor (FXR) agonist, TERN-101, a semicarbazide-sensitive amine oxidase (SSAO) inhibitor, TERN-201.

2018-04-04
GenSight

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.

2018-04-04
SigilonFlagship-seeded Sigilon, $473 million deal with Eli Lilly on stem cell Type 1 diabetes, $63 mil upfront2018-04-04
Arvinas

protein degradation by recruiting E3 ligase. Series C $50M fund. C4 Therapeutics and Kymera same strategy.

2018-04-04
PFE

dacomitinib EGFR inhibitor for NSCLC. Priority review

2018-04-04
Allogene

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

2018-04-03
RIGL

Oral SYK inhibitor for IgA Nephropathy failed PhII. NDA on Immune Thrombocytopenia, PhII Autoimmune Hemolytic Anemia

2018-04-03
AZNanti-CD22 for 3rd line hairy cell leukemia
2018-04-03
SLS

Galena's NeuVax is the E75 synthetic peptide from HER2/neu proto-oncogene (HER2/neu p366-379) combined with rhGM-CSF

2018-04-02
MNOV

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

2018-04-02
Macrolidesame scientific founder Andrew Myers as failed Tetraphase $TTPH
2018-04-02
LLY

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.

2018-04-02
ALKS

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.

2018-04-02
ABUS

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

2018-04-01
ARDM

01.29.2018 CRL concern include clinical data, human factors validation study and product quality.

2018-04-01
NKTR

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
03.20.2017 first-in-class opioid analgesic without addiction and abuse PhIII success.
11.07-11.20.2017 NKTR-214 combo data triggered a 4-fold rise in 4 months. But data not that impressive. 7/11 (63%, 2CR) in naive melanoma. 3/4 PR in NSCLC

2018-03-31
CLDXOur collaborator at CellDex progress Flt3L CDX301 into PhII cancer trials
2018-03-31
ZSANZosano 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
EDGE

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

2018-03-31
VRNA

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.

2018-03-31
DVAXAZD1419 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
ALNY

$IONS $PFE Pfizer’s positive PhIII tafamidis data makes drug a new rival

04.02.2018 further panic drop

2018-03-29
MNOV

MN-166, a old drug called ibudilast, repositioned for neurodegenerative disorders and substance abuse. fail

2018-03-29
Fujifilmbuying cell culture media companies due to rise in IPS and cell therapies
2018-03-29
REDXPorcupine inhibitor Wnt pathway RXC004 safety issue, to try low dose
2018-03-29
AGRXPerceptive increased position by 150K now above 10%
2018-03-29
ABUSModerna is still working on LNP, hiring postdoc
2018-03-29
ABUS

ABUS Galnac abstract fo EASL along with AB-506 (2nd gen capsid) and AB-452 (RNA destabilizer)

2018-03-28
ACRX

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).

2018-03-27
DVAXWHO 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
BHVN

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.

2018-03-26
SGEN

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

2018-03-26
ABLX

Sanofi's ABlynx, nanobody against IL-6R vobarilizumab failed in PhII lupus. Failed before in PhII RA.

2018-03-26
PTGX

peptide ulcerative colitis drug PTG-100. High placebo response

2018-03-26
SURF

CD47, CD73, tumor microenvironment, Surface Oncology

2018-03-26
Allecra

extended spectrum β-lactamase inhibitor known as AAI101 against multidrug-resistant gram-negative bacteria

2018-03-26
ARNA

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.

2018-03-24
ACRXAdd 960 shares ($2k)@$2.05
2018-03-23
ABUS

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.

2018-03-22
REGN

$ALNY found genetic factor HSD17B13: touted as PCSK9 of NASH

2018-03-22
ABBVDuring 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
ModernaHK and NASDAQ dual IPO as early as 2019. Also Grail
2018-03-22
ALDR

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.

2018-03-21
ABUS

drop 28% ( $6.1 -> $4.4 ) after Q4 no deal / no progress report. Speculators leaving. No buyer.

2018-03-21
AGRXdrop 25% after Q4 no progress report. Speculators leaving. No buyer.
2018-03-21
DVAXAdd 115 shares ($2k)@$17.30
2018-03-21
CHMAMPOWERED trial more responders than expected. ~130 instead of ~150 patients is needed.
2018-03-20
PTI

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”

2018-03-20
ARNA

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

2018-03-20
NOVNalso had positive PhII results in 2015.09.29. p < 0.01. didn't translate in to PhIII
2018-03-19
DERMits PhII results on 2016.5.10 reported positive results with p<=0.001. Then PhIII completely mirror placebo
2018-03-19
AOBiome

Huiying LI (UCLA) told me. Using Ammonia Oxidizing Bacteria Nitrosomonas eutropha found in soil to produce Nitric Oxide to treat Acne. Passed PhII.

2018-03-19
NOVNNOVN 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
ANTH

repeat failed PhIII with more agressive dosing , fail again. Lost 99.5% value since 2015 high.

2018-03-17
SLDBDMD 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
ALXNAlexion 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
EARS

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.

2018-03-17
OREX

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

2018-03-17
IONS

licensed inotersen AKCEA-TTR-LRx to Akcea ( AKCA 75% owned by IONS after deal)

2018-03-17
NOVN

Noacne. Nobel winner Lou Ignarro said Nitric oxide NO is not antibiotic, it is what WBC use to kill bacteria

2018-03-16
Prexton

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.

2018-03-16
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
DVAXAACR abstracts out embargoed. Both Dr. Cohen and Dr. Ribas to give poster presentations.
2018-03-14
ABUSQ4 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
Crinetics

Founded by ex-NBIX people. CHMA competitor: Small molecule nonpeptide somatostatin agonist CRN00808.

2018-03-14
NOVNWen 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
PTI

up 50% on cystic fibrosis breakthrough status

2018-03-13
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

2018-03-13
TEVAreturns CGRP antagonist small molecule to Sosei. Its own anti-CGRP antibody falls behind competitors, losing market potential.
2018-03-13
AGRXQ4 Report Type A meeting requested. Expect resubmission Q2, 6 months review.2018-03-12
RGLS

anti-miR-17 started in hepatocellular carcinoma (HCC), ended up in kidney disease ADPKD

2018-03-10
GLYC

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

2018-03-10
GTHX

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

2018-03-10
DERM

Phase III complete failure reverse from Phase II. Previous note right on high price and consistent insider selling. #acne

2018-03-10
CLSD

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

2018-03-10
VBLT

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

2018-03-10
DVAXHalf hour sell off after ER, then reverse.2018-03-08
ACRXMeeting minutes not surprised. Zalviso sales will be slow until 2019.2018-03-08
XENENav1.7 inhibitor rare mutation no Pain. Topical didn't meet endpt. Genentech working on oral selective inhibitor.2018-03-08
RoivantVivek Ramaswamy’s public companies. Model: take big companies low priority drugs and develop it separately (reduce "traffic jam”), new venture for Diabetes: Metavant2018-03-08
Refuse to filemanufacture related; production record (ACOR); device information (STDY); additional information.2018-03-08
OTICOTIVIDEX 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 FailuresDNDN (8bil), MNKD (4bil)2018-03-08
ADROSTING pathway leader and other immunooncology2018-03-08
ACAD09.09 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
ABUSRegulus using LNP to deliver Anti-MiR for HCC. Gritstone/ALNY/SGMO/CRSP/NTLA/Generation Bio/Moderna/Regulus2018-03-07
RGLS4Q CC announced challenge recruiting patients to Alport trial, now enroll til 2H2018. ADPKD progress OK. Down big 20% next day.2018-03-07
OselMicrobiome therapy for vaginitis, inspired by Wen2018-03-07
GILDHIV shock and kill to reactivate reservoir2018-03-07
ABUSChat w. Dr. Saab Dr. Nazem Afdhal (Spring Bank)2018-03-05
AGRXWen 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
DVAXSD-101 trial 7 sites withdrawn. Why? DV281 3 more 4/5 recruiting.2018-03-01
RubiusRed Cell Platform2018-03-01
PearPrescription digital medicine, app to manage neuro disease2018-03-01
CognitoTxBrain wave removes plaque Nature Podcast2018-03-01
DVAXAdd $1.2k@16.42018-02-28
ABUSGeneration Bio uses LNP to deliver ceDNA; Moderna now valued at $7.5B, possible $20B IPO2018-02-27
ACRXRead Acelrx received Day 180 questions to Feb CHMP during 19-23Feb. Add$1k@1.852018-02-27
AGRXAdd $1.2K(318)shares@$3.782018-02-26
Moderna19 pipeline; value at 7.5B pvt. 20B IPO?2018-02-26
SGMOZFN gene editting; GILD CAR-T deal; LNP license2018-02-24
RGLSWuxi STA manufacture partnership with RGLS.2018-02-22
DVAXACIP recommendation. 2.20.2018 $175M ($100M+75M optional) loan. Abstract submitted.2018-02-21
ACRXRBC conference. Zalviso will be delayed after Dsuvia resubmission by 1H18. 2.23.2018 FDA approved KMPH’s Opioid pain killer without abuse deterrent label2018-02-21
AIMTPhase III good, but pop then sell off the same day2018-02-20
APRItopical for ED. CRL for CMC and Safety2018-02-18
PCRXOld candidate using DepoFoam technology, approved since we studied; but share price kept falling since 2015. AdCom4-62018-02-17
ATRSPartner product for preterm birth approved2018-02-17
RGLSRead 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
DVAXNektar big deal with BMY for its IL2R(CD122) agonist.2018-02-14
ABUSCFO 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
OPKNow $3. Great decision I sold. Revenue declined!2018-02-12
CHMA

Back to $1.5. Expect a long flat base.

2018-02-12
AXONanother fail on DLB. CEO David Hung left 10m in position2018-02-12
DVAXRead more about OX40 big company pipeline and Idera merge and IMO-8125 phase III2018-02-05
ABUSAdd 1k(202@4.95) 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
DVAXAZN Other Asthma fails. Ron Levy SD-101+aOX40 STM paper 2.5.2018 add 84@$17.85(1.5k)2018-02-02
ABUSAAV safety problems.2018-01-30
ABLXNanobodies, bot by Sanofi2018-01-29
ABUSRead ego@IV’s analysis on injunction ruling ABUS vs. Acuitas and SGMO relationship. and ABUS VIDEO.2018-01-25
ACRXadd 1.5K@2.052018-01-23
EIGRtrial disappoints.2018-01-22
DVAXAdd $2k@15.65 more at 200MA; Add $1k@17.72018-01-19
ABUSAdd $1k@5.15 more near 200MA.2018-01-19
DVAXFound 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
SGYPGI Fluid regulators2018-01-15
MDGLNASH trial success announced 12.6.20172018-01-15
KDMNROCK inhibitor for autoimmune and fibrosis; too much debt, interesting MOA; major holder selling2018-01-15
DERMDermatology, Acne by targeting sebum enzyme, not cheap stock, low but consistent insider selling2018-01-15
BHVNOral CGRP inhibitor; moderate insider selling2018-01-15
AXSMa few neurology drugs don't understand; AXS-02 pain inhibitor (by inhibiting Osteoclast secreting proton) discontinue one but continue on another Knee trial2018-01-15
ARDMInhalable form. Cipro for lung diseases; mediocure trial efficacy results; AdCom not very good.2018-01-15
ALDRanother CGRP for migraine, but worry it may not compete with Amgen's erenumab: better MOA and safer2018-01-15
DVAXJPM 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
AGRXPop up $3 due to 13G 9.9% stake by Perceptive Advisors.2018-01-09
DVAXHeplisav-B launched. WAC $115/dose, $230/regime; CDC listed Engerix-B $55.65/dose.2018-01-08
DVAXCash YE $191.7M, same as Q3; IBD interview confident launching on their own; AZD1419 completed enrollment actual enrollment 81 vs. 67planned.2018-01-05
ABUSAcuitas discussion on IVillage. Sangamo used Acuitas LNP.2018-01-05
NKTRNKTR-214 IL2R agonist, stimulate T and NK cells.2018-01-01
DVAXMK-1966+SD101 combo completed enrollment, preclinical Abstract; possible readout on ASCO18; H&N paper (JCI insights 09.2017)2017-12-31
VNDAprevious PSIC candidate; not so impressive revenue with two products.2017-12-30
BOLDAAV gene therapy for MTM1 mutated X-Linked Myotubular Myopathy2017-12-30
AGRXA flock of analysts downgrades at $2; when they upgraded at $5.2017-12-26
LJPCangiotensin II for IV. No big change after approval2017-12-23
AEZSmacrilen for aGHD. know this CRL for long time. Horrible company price history. Still only $50M cap after approval.2017-12-23
AERIApproved no big change.2017-12-23
ABUSAcuitas trial date 2.19-3.2.20182017-12-22
AGRX99.2-99.7% 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
AGRX

2nd CRL: Adhesion issues (unexposed risk) on CMC and trial results interpretation. Cash can fund till YE2018-1Q2019 if no new activity required.

  • Pearl Index not a problem
  • correction with adhesion vs BMI and others
  • response timeline and cash
  • test method was cut into strips advised by FDA
  • why not delay? me: FDA don’t expect a quick reply
  • adhesion study common in patches FDA guideline
  • type A meeting 3.5 months average: ACRX/Sorrento
  • Some sold premarket at 1.05
2017-12-22
ONCEAn-chieh told me. Heavy selling. Eye drug approved but hemophillia fell short. Share price halved2017-12-22
AGRXOrtho Evra had BMI warning.2017-12-20
ACRXRead 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
RGLSRGLS4326 phase 1a in healthy volunteers initiated.2017-12-19
NVAXphase 3 failure. Used to worth 3.4B and $13 now 200M and less than $1. $300M debt financing red flag. Continue to disappoint2017-12-19
NLNKIDO 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
ABIOA tiny company with new beta-blocker; 17M Mcap, 8M Cash2017-12-16
EIGRLTB4 inhibitor for Pulmonary Hypertension; good chart2017-12-15
ACRXARX-04 NDA: no big change since. Different reaction compared to 2013 due to different market condition and ACRX expectation2017-12-13
ARGXARGX-110 anti-CD70 for cancer; positive Phase II data at ASH 2017; more: anti-MET, anti-GARP2017-12-13
DVAXAdded to XBI index between 20170908-12112017-12-11
ABUSAdded to IBB index. Ladenburg Thalmann unloaded in 3Q2017.2017-12-11
ACRXType 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
BGNEFound moderate insider selling by CEO John Oyler2017-12-11
SAGEGABA NMDA CNS disease; Brexanolone failed in 1 trial (09.2017) but success in another (11.2017); then SG-217 success2017-12-09
RVNCBotox-like for skin wrinkling; aesthetics2017-12-09
RARXRaPharma; Complement C5/C5b inhibitor; as Alexion C5 inhibitor competitor2017-12-09
PTIProteostasis network2017-12-09
MLNTFusidic acid (approved in other countries) for ABSSSI. Small MCap even though one approed product2017-12-09
KALAMPP tech for better eye delivery; NDA; 7/20/2017 IPO2017-12-09
GALTGallectin inhibitors for NASH or Cancer2017-12-09
DVAXNaive fully enroll December 2017, non-naive early 2018, possible data release at ASCO2018; Sci-B-Vac (Nasdaq:VBIV) was merged on May 6 20162017-12-08
RGLSall directors bought shares on 12.4.2017 at $0.892017-12-08
MedivationSold to Pfizer for 14B; product disappointing; PARP inhibitor disappointing too.2017-12-08
ACRXread about previous human factor CRLs; all approved later, 1 year delay. "Human factors studies are NOT clinical trials.” PDA comments.2017-12-07
ASMBwait 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
LOXOMultiple Cancer mutation targeting agents; 400+650 deal with BMS; 2017-11-19
PIRSanticalin drug chaperon or fusion protein2017-11-17
MYOKcardiovascular2017-11-17
MRTXKRAS first in class tyrosine kinase in NSCLC + Opdivo combo; NSCLC PD-1 Progress 3/11 PR2017-11-17
MRNSGanaxolone; GABAA neurology drug2017-11-17
MDGLThyroid 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 185M2017-11-17
IMMUSeatle Genetics wanted to buy; venBio faught back; CEO/CSO had to leave; David M Goldenberg founded in 19852017-11-17
EXASCologuard Test2017-11-17
ESPRLDL lowering drug2017-11-17
CBAYLiver and other chronic diseases2017-11-17
CALATumor metabolism; Aminoacidases inhibitor2017-11-17
AVEOVEGF inhibitor2017-11-17
ABEOAAV gene therapy2017-11-17
ACRXmaximum dose 15mcg/20min plateaus at 8-12 hours; Dsuvia’s 30mcg/hour is fine2017-11-15
DVAX
Submission #AcceptanceAnnounce AdComAdComPDUFA
1st6.26.128.28.1211.14-15.122.24.13
2nd3.30/4.27.168.5.16 (cancel 9.4)11.16.169.15/12.15.16
3rd2.28.174.3.177.28.178.10.17/11.9.17
2017-11-10
DVAXHeplisavB approved. Sell on news.2017-11-09
RGLSCompany 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
STMLIL3R cancer stem cell target therapy2017-11-04
NBIXIngrezza exceed estimates2017-11-04
ALNYNew results show better than IONS and pathology improvement2017-11-04
ACRXNow good time to add more? Wait for TA. It tells a lot. Add more @1.92017-11-03
PTCTTranslarna, unknown mechanism on DMD, up on mixed ADCOM; CRL again.2017-10-28
MGNXDART; bi-specific and other antibodies. Incyte deal.2017-10-28
QUREAMT-061 for Hemophilia B advanced to phase III2017-10-21
EXELKinase inhibitors for oncology2017-10-21
DRRXlong time candidate; pain medicine; POSIMIR failed phase III; remoxy long time failure2017-10-21
DBVTFood allergy skin patch, see AIMT; ViaSkin Peanut failure phase III, small diff.2017-10-21
AIMTFood allergy oral pills; heavy insider selling; see DBVT2017-10-21
DVAXDV281 NSCLC initiated2017-10-19
ABUSALNY end ALN-HBV development; Gritstone Oncology signs LNP deal for mRNA delivery.2017-10-18
DVAXACIP Updated agenda no vote; bear attack then reversal2017-10-16
ATRSDrug/Device combination; auto injectors; 10.2017 CRL2017-10-15
ANABin vitro Somatic Hypermutation; 2017 IPO; P2a positive results2017-10-14
AERInew 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
DVAXRead CDC/ACIP agenda first item is Heplisav-B2017-10-12
ACRX

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

2017-10-12
ACRXSentiments on twitter (proven useless 10.12) are mostly skeptical short citing opioid crisis and commercial failure.2017-10-11
AGRXanalyst 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
DEPOfound this previous candidate lost 80% value since 2015. Mostly chronic opioid pain products2017-10-10
ALNYRaised fund a few months before Patisiran data; Fitusiran fatal thrombosis; Patisiran great results. up 52%. 2017-10-08
ACRXFound competitor the Medicine Company’s IONSYS withdrawn with marginal 2016 full year sales.2017-10-07
RYTMIPO. 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
MCRBUlcerative Colitis P1b for SER-287 results disappointing, especially clinical response; endoscopic and remission seems better2017-10-07
FENCSodium Thiosulfate for the prevention of ototoxicity from cisplatin in pediatric patients2017-10-07
ACRXGetting nervous. Saw latest PPT, zalviso accelerating in Europe. Zalviso.eu Website well designed.2017-10-03
ECYTLicensed P3 ready candidate from Germany; share price exploded from $1.4 to $6 in 2 days2017-10-03
ABUSRoivant 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.2017-10-02
ACRXDSM SinoChem Pharma found Acelrx home page news page not available. Potential early approval? Speculation2017-10-02
DVAXRead Reuters rumor on HeplisavB deal. ABUS AASLD Ab#929 using HeplisavB; manufacture resumed2017-10-01
ABUSAbstracts out for AASLD: ARB1467+aPD1+Vaccine (That's basically HeplisavB!) PR out 10.32017-10-01
ACRXI feel uncertain and people on twitter feel uncomfortable with the rapid run-up.2017-10-01
ZYNEFirst and only synthetic cannabinoid, up on P2, retrace on tweet says same as placebo2017-10-01
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
DVAXClinicalTrials.gov updated AZD1419 to "active not recruiting” on 9.22. Primary completion 9.3.20182017-09-28
CHMA

First patient randomized.

2017-09-27
ABUSIt seems Sangamo Intellia CRISPRTech all using LNP; 9.27 ARWR made a lame PR on genome-integrated HBV sAg production2017-09-26
ABUSIV 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
ACRX2 day breakout to new 52 wk high without news; continued higher like a pre-PDUFA run2017-09-26
AXONfailed 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
ABUSReports promising cohort 4 data. Some sell on news; but risk off.2017-09-25
VSAR/ASNDlong acting hGH didn't meet non-inferiority against Genotropin, delay behind competitor -88%; Ascendis TransCon releases native GH up 23%2017-09-22
ABUSALNY reported positive Patisiran data, superior efficacy and safety; ABUS pop 41% before closing up 21%.2017-09-20
CHMA

Exited at $2.40 resistence to buy ACRX. (good decision 2018-03-10)

2017-09-20
PRQRQR-010, CFTR F508del systic fibrosis, RNA therapeutics2017-09-16
FOLDATB200, replacement enzyme with small molecule chaperone, already high2017-09-16
FCSCFCX-007 Col7 gene therapy, autologous fibroblast; I am skeptical about its MOA.2017-09-16
FENCList on NASDAQ from OTCQB. 2017-09-13
AMGNDVAX 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 Heart2017-09-13
ABUSAnnounced LNP webminar; Alnylam's hemophilia drug suspended due to "fatal thrombosis". Not using LNP. Webminar announced solid data; market not convinced.2017-09-12
KURArecycle JNJ old drug Tipifarnib, a farnesyltransferase inhibitor2017-09-09
INSMliposome for lung delivery to avoid charged enviroment in lung infection; improve drug delivery2017-09-09
CLLSCellectis universal CART; clinical hold after fatality2017-09-09
ITCIFDA agrees that the metabolite is not present in human. up 40%. Doubled.2017-09-07
NVSCART approved. Oncology: “Great pricing power, fast market penetration, when target is right, ability to expand into more cancer types."2017-09-02
SYRSSY-1425 in licensed from Japan for RARA super-enhancer cancer. But heavy selling into ESMO 09.20172017-09-01
SELBSelecta. Immuno tolerance. SVP+Rapamycin. Not very interesting.2017-09-01
ACRXtalk 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 partnership2017-08-29
ABUSFirst New 52 wk high in years. Dr. Saab (Bot around $3) and Bau (around $5) are both in ABUS.2017-08-28
KITEbot-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. Endpts2017-08-28
DVAXUK firm Vectura announced deal with Dynavax allowing using its AKITA nebuliser with DV281 for lung cancer.2017-08-18
RGLSListened to CC. Knew Reata 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
CHMA

Announced new trial agreement with FDA. Trial results expected end of 2019. EU results 2020. So buy around end of 2018?

2017-08-10
DVAXPublic 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
DVAXnew 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
JNJSirukumab (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
DVAXPDUFA delay due to REMS details. CC very optimistic. BMS acquired IFM (NLRP3 STING Innate I/O).2017-08-03
ABUSQ2 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
DVAXQ2 ER show raised 88.2 million by ATM. average $5?2017-08-02
AGRXPublic 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
ACRXGreat 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
CHMA

Should read more about oral delivery of peptide, annual report when above 200ma

2017-08-01
ACRXPR 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
DVAXVRBPAC AdCom 12-3-1 (Y/A/N) AH +90%; next day close +71.4% w. 23M volume (55M total)2017-07-28
ABUSALXN terminated collaboration. -6.7%. Break 50MA.2017-07-27
AGRXFDA Accepts NDA; PDUFA 12.26.2017 +7.6% but go down for consolidation later.2017-07-27
DVAXVRBPAC AdCom Briefing doc. Down spike 18% before rise and close +5%. Down 11% 2day. More death but due to opioid overdose.2017-07-26
AGRXTA break out 200MA on volume without news (HC Wainwright initiated) 7.26 TA fill gap down 10%+2017-07-19
RGLSannounced 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
CLVSEGFR 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
ACRXand 7.17: sharp rise due to Jefferey’s upgrade. 7.19 new CFO, technical drop2017-07-14
GWPHoffering at $90/ADS (2.8m; 25.33m total after). Wait for it at $10.2017-07-13
ABUSJuly 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
MTNBlipid crystal delivery failed P2.2017-07-01
NERVOrexin inhibitor for insomnia. Other neuro assets2017-07-01
MCRBSeres Thera. heavy insider selling precedes clinical failure; Incyte deal.2017-07-01
ITCIPSIC #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
FimbrionTargeting Virulence Instead of Viability. Use FimH antagonist to detach virulent bacteria.2017-07-01
David BaltimoreAmgen; MedImmune; ImmuneDesign (like Dynavax); Calimmune (Private); Regulus. Also read about Paul C. Grint current company Apliphi (from $300 to penny on bacteriaPhage nano cap $6M). (20min)2017-07-01
CRISPR CompaniesCRSP; NTLA; EDIT; Caribou. All insider selling. Years away from success. TradingView CRISPR index. Other gene editing companies. Cellectis, Sangamo. Everybody is using LNP2017-07-01
DVAXread about SD-101 in prostate cancer trial. Keytruda approval in any solid tumor with biomarker.2017-06-30
CARAkapa-opioid receptor inhibitor. Miss endpt.2017-06-30
AGRXresubmit; no change2017-06-27
DVAX$IDRA got Orphan designation; $DVAX probably getting Breakthrough Therapy soon.2017-06-22
ABUSspeculation that SGMO raises fund for LNP technology deal from IV board. Ego wrote a great article on LNP IP landscape.2017-06-20
RGLS1.5h Read Regulus publications, community/charity, work-life, Jay Hagan resume, IR website. Very transparent. Founder CEO Kleanthis Xanthopoulos left June 2015; CMO->CEO left May2017; Refocus. Heavy insider selling from 2012-20152017-06-16
RGLS1.5h Read more about RG-012 (miR-21) and miR-17 in kidney disease (JCI paper and Nat. Comm. paper), clinical trials ATHENA and HERA. Its work environment and culture. Competitor miRagen ($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
ABUSlearned $ALNY issued new shares last month, pending Patisiran P3 release. Bad results, or company knows it's priced in already?2017-06-13
CHRSCRL announced. Down %30.2017-06-12
DVAXNewLink NLNK IDO inhibitor returned by Genentech 90% loss since 2015 high2017-06-10
ACRXENDP's Opana ER withdrawal by FDA. 90% loss since 2015 high2017-06-10
DVAXLeader: Antoni Ribas2017-06-09
DVAXSteven 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
ACRXZalviso was designed with IDEO video. Won reddot award.2017-06-07
ACRXFDA 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
ACRXTim Morris CFO left co. Co. registered $150 mil security shelf.2017-06-05
DVAXDynavax 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
ABUSSofia info2017-06-01
AGRXCEO Good guy2017-06-01
RGLSRegulus 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 11.20142017-06-01
AKBAHIF pathway for Erythropoiesis (马宇)2017-06-01
ACRXread Three Arch now owns 9mil shares; perceptive 5.4 mil2017-05-31
GWPHAfter reaching 3.5B market cap three times ($138 peak), seems GWPH has topped and top institutional holders are reducing. 2017-05-31
DVAXRead 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
ABUSModerna top attorney quits STATNews2017-05-27
Steminasmall private biomarker company with big world leader claim. Not so interesting2017-05-27
ARGXIPO. ARGX-113 binds FcRn, blocks IgG recycling (including disease causing autoantibodies) and increases IgG clearance2017-05-18
CHRSHumira patent invalidated. 2017-05-17
DVAXFive >300K increased positions institutional owners. include two million share increases. (Top2: Federated, GMT)2017-05-13
DVAXRead 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
ABUSNew >5mil position by Ladenburg Thalmann (12.31.16) New 2.7mil by RTW (Top2: QVT and Ladenburg)2017-05-13
ACRXSaw >2mil shares BlackRock? new position, became 2nd biggest (Revised later). Otherwise institutional owners reducing (Perceptive)2017-05-13
AGRXFive >300K increase institutional ownership (Top2: ProQuest, InvestorAB)2017-05-13
CHMA

Saw one >200K new institutional owner (3.31) (Top2: MPM(Pharmasset), FMR-Fidelity)

2017-05-13
AGRXCEO and CCO open market purchase of 63.3k shares and more option execution2017-05-11
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
OPK

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!"

  • Science too complicated.
  • Value priced in based on expectation
  • Should have sold after stock merge.

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.

2017-05-10
DVAX1q report reveals ATM financing of 48.4million (10mil shares); importance of finance planning for worst scenario2017-05-08
ACRXZalviso trial completed 3 months early than planned2017-05-08
AGRXannounce irregular bleeding days results. Twirla actually decreases irregular bleeding2017-05-06
OPKFinancial report full of promoting language and error, flat 4K QonQ and lack of focus. Decide to sell.2017-05-01
CHMA

My Estimate: late 2017/early 2018 initiate trial; late 2020 results; EU trial results 2019.

2017-05-01
DVAXSA article compares other combos2017-04-30
ACRX~2h Read about Zalviso EU launch progress Jan17 ppt Apr17 ppt2017-04-30
AGRXbreakout cup and handle without news; shorts trying to spill out quick “facts” DrSternbergMD.2017-04-28
CHMA

bottom? at 40% cash value $1.55/shr

2017-04-28
ABUS5 weeks tight pattern prior to EASL; cohort 3 data not as exciting as expected, no move. -> 8 weeks and counting2017-04-21
AGRXThesis Post 3.5 hours2017-04-09
DVAXAdCom announce too close to PDUFA2017-04-03
ACRXIndeed 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
RTTRlactose 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
AGRXRead 8-K about FDA meeting minutes on UB arbitrary limit; and Trend chart and same drug later study2017-03-22
AGRXBreak out2017-03-16
ABUSAlexion deal 7.5mil2017-03-15
DVAXResubmission accepted. Q2 AdComm, Aug10 PDUFA2017-02-28
DVAXAdd more at 4.10, bring average to ~$122017-02-16
ACRXNew CEO2017-02-16
AGRXadd more on V day after talking to An-Chieh, bring average to $5.852017-02-14
CHRSInsider selling is a big warning sign. secondary offering @242017-02-07
ABUSRead about Arbutus Acuitus litigation and Moderna2017-01-15
OPKClaros platform initiated.2017-01-15
AGRXThree days later: start to read more, Confident comes back. Emotion ebbs.2017-01-04
AGRX

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.

  • LIsten to Twirla conference call
  • Quartette trial FDA review; other CHC safety profile
  • The only LNG transdermal

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.

2017-01-01
Vanderbilt Cancer CenterPathways, Anti-cancer agents, Targeted, Immune-oncology etc. New Immu-Onco drugs2017-01-01
OPKhGH-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
OPKRead about exenatide and liraglutide and glp-1 diabetes drugs. Seems TT401 MOD-6031 in a tough position2016-12-15
ABUSARB-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
DVAXCancer R&D day slides promising2016-12-09
ABUSArrowhead programs canceled2016-11-30
DVAXCRL. 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
DVAX

Trump win. More preliminary 0.5hour. Ref BRAF inh. and T-Vec

2016-11-09
DVAXEveryone miss the main point: SD-101 oncology. too far away2016-10-10
DVAXSD-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
OPK4KScore report no cover from Palmetto/Medicare LCD. Novitas MAC2016-10-07
CHMA

Tight Junction Permeable - Growth hormone problem. There are responders. 1st CRL. Get in too early, before seeing bottom. #oraldelivery

2016-10-07
DVAX

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.

2016-10-04
ABUSARB-1467 release: 1day chaos. Chardan cites efficacy "fail"2016-09-30
ACRXNew trial2016-09-27
ACRXARX-04 results2016-09-15
OPKTT401 abandoned by Lilly due to inferoity in reducing HB1Ac2016-06-30
OPKCMC CRL didn’t matter2016-03-30
OPKBig drop after BRLI buyout. Should have exit2015-10-02
ACRX2015.07.24 Zalviso positive CHMP; 09.21 PDLI deal; 09.22 EMA approval
2015-09-22
ABUSPublic offering at $20.252015-03-01
ACRXRefuse bench testing. Pamela Palmer video https://www.youtube.com/watch?v=X8Js8VfFJ_o2015-03-01
ABUSTekmira acquired Oncore2015-01-12
ABUSFound Oncore; acquired Enantigen and license others2014-09-01
ACRXCRL2014-07-25
ACRXCMO Pamela Palmer resume.2014-07-01
DVAXorignial IPO $7.5 ($75 after rev-split)2004-02-19