TicNoteRecorded
    SRPTcase submitted to FDA Adverse Event System, later says error, still down 14%
    2019-08-12
    CLVSCompetitors AstraZeneca and Merck announced positive data from a Phase 3 trial of Lynparza in men with metastatic castration-resistant prostate cancer (mCRPC). Clovis also announced an offering of $225m of convertible notes.
    2019-08-12
    KALAKPI-121 for dry eye disease CRLed. FDA requires 3rd Ph3 data coming in 4Q19. Previous 2 Ph3 data were mixed.
    2019-08-12
    AMRNsurprising AdCom scheduled 11.14.2019, no ADCom was expected, PDUFA extended 3 months. down 17%
    2019-08-12
    NKTRdown 29% to $20.92 on news that suboptimal batches of NKTR-214, in combination with Bristol-Myers’ Opdivo, were given to some patients in trials, which caused a softening of responses.
    reducing $BMY collab scope
    FDA suspended new opioid app
    2019-08-12
    GKOSiStent inject Eye pressure Glaucoma relief company bought Avedro $AVDR corneal health business, up 28%
    2019-08-12
    AMGNwon litigation against Sandoz on Enbrel patent. extend Enbrel to 2029
    2019-08-12
    MRNAheavy selling since #ASCO19
    2019-08-12
    ALLK
    a therapeutic antibody that targets Siglec-8, an inhibitory receptor found on the surface of mast cells and eosinophils. We are testing AK002 in a number of diseases where eosinophils and/or mast cells have been shown to play a role in the disease pathology.

    met all primary and secondary endpoints in its Phase 2 trial of AK002 in patients with eosinophilic gastritis and/or eosinophilic gastroenteritis.  up 174%, recent IPO straight success
    2019-08-11
    IDRAmaking progress on its TLR9 program
    2019-08-08
    RGLS2Q19: private placement, debt restructure, office move, new CFO, and focus on RGLS4326 for ADPKD, perclinical NASH anti-miR132 to seek partner
    2019-08-08
    CLSDto out license XIPERE, R&D expense only $0.7mil. Up 28% fron $1, penny zone
    2019-08-08
    DVAX

    IV post: 1. priced above open market price $3 vs $2.99 close. 2. demand $70.1M more than proposed $60M 3. some buyer prefer not to be identified. A potential buyer?

    Compare to my desperate emotion of bankruptcy?

    Me: SD-101 may be a dead asset, at least in the near term. Could not find any buyer, hence the raise.
    2019-08-08
    CHMAexpect NDA YE19, MPowered trial results 2H19, 58mil cash, 8m/Q burn
    2019-08-08
    ALNY

    sales up, canada and japan approval, CEMEA progress, 2B cash, 1B/year cash burn, CFA change, strong pipeline, $400M upfront +$400M equity deal with Regeneron.

    Vutrisiran a risk factor for ONpattro and $ABUS
    2019-08-08
    ABUS

    Vir.Bio licensed $ALNY ALN-HBV02 as VIR-2218 ESC+ GalNac RNAi. trial started 11.2018. $ABUS 8 months late. Single agent

    Johnson & Johnson's Janssen unit paid $ARWR 25mil related to the start of dosing of a patient cohort in the phase 1/2 clinical study evaluating a triple-drug combo of JNJ-3989 (formerly ARO-HBV), JNJ-6379, and a nucleotide analog in Q2. $ABUS a year late triple combo

    $DRNA started Ph1 DCR-HBVS in 01.2019, $ABUS half year late. Single agent

    2019-08-08
    CRL Rev
    $BHVN
    $BHC $ETON over-the-counter (OTC) preservative-free formulation eye drop for the treatment of ocular itching associated with allergic conjunctivitis
    $ACER
    $HRTX
    $NBRV
    2019-08-07
    PIRSPRS-060 serves to treat moderate to severe asthma through direct delivery of a potent IL4Ra-targeting Anticalin protein to the lungs. Announced late-breaking presentation of Phase 1 multiple ascending dose trial
    2019-08-07
    MYLMylan to Merge wit Pfizer's Upjohn.
    2019-08-07
    DVAX

    8.3 million Q2 sales, 32-36mil FY19. No deal. public offering 60m. Bankruptcy / Reverse Split coming?

    Ph4: The interim analysis in the study are not time based analyses, rather they are event driven. And thus, the timelines for data are based on projected rates of cardiac events, which have been consistent with original expectations.

    Priced: 23.365mil shares at $3 for $70.1mil. 0.25 share warrant per share priced at $4.5. Not bad.

    2019-08-07
    GLYCrivipansel (GMI-1070) for sickel cell disease miss endpoints
    2019-08-07
    ACRSATI-501 JAK1/JAK3 Inhibitor Oral also mediocre in Alopecia areata, Pfizer better. Topical failed in June.
    2019-08-07
    ACRX2Q19 still no revenue, making progress
    2019-08-06
    BigPic

    new fear on trade war, sharp drop in big market. TA looks good.

    08-14-2019 Trump blinked, postpone the deal for Christmas Season
    2019-08-06
    BiotechArie Belldegrun and the crew at Vida reap a $600M harvest for fund II — and they've got LA in their sights2019-08-02
    AGRX

    Q2 raised ATM cash $1.4m ~1m shares at $1.4; public offering announced when current cash till end of 2019. Priced $0.95 for $12M

    Over-Allotment fully exercised. Total net proceeds $12.6mil on 14.5mil shares. Bring shares to 59.1mil
    2019-08-01
    BigPicFed lower rate by 25 base points, and hint "midcycle adjustment", not a start of new trend
    2019-07-31
    AMGNup 5.7% on increasing demand for its new drugs
    2019-07-31
    ABUS$MRNA Moderna is trying really hard to challenge LNP patents. '069 patent IPR was instituted on 7.24.2019 IV post
    2019-07-30
    MRNSGanaxolone; GABAA neurology drug fails in women with postpartum depression (PPD) down 71%
    2019-07-29
    ACADmiss Ph3 Enhance trial of pimavanserin as an adjunctive treatment in adult schizophrenia patients2019-07-29
    NTECAccordion Pill-Carbidopa/Levodopa (slow release) miss Ph3 in Parkinson's. Down to penny
    2019-07-29
    ACHN2nd gen complement Factor D inhibitor ACH-5228 pass Ph1 MAD in HV, up 95% week
    2019-07-29
    LXRXSanofi $SNY terminated collaboration to develop Zynquista (sotagliflozin) in all diabetes following mixed Ph3 data. Lexicon considered it invalid and in breach of contract
    2019-07-29
    ITCIadcom cancelled schizophrenia drug, lumateperone tosylate capsules
    2019-07-24
    IONS$BIIB posted Q2 earnings, Spinraza (licensed from IONS) sales only 15% increase, disappoints
    2019-07-23
    CHMA

    OPTIMAL trial met primary and secondary endpoints 2 months ahead of schedule. up 40%. 90% choose to stay, 58% vs 19% placebo maintained IGF-1 response.

    sell off on news, 2 days to below pre-news level. Proposed offering. $5.5 per share 10mil shares
    2019-07-23
    AMGNfirst cancer biosimilars approved Mvasi (bevacizumab-awwb) and Kanjinti (trastuzumab-anns). Rituxan biosimilar also coming. Uptake will be slow.
    2019-07-21
    SGENAdcetris (Brentuximab vedotin, CD30 ADC) doing well. enfortumab vedotin (anti-Nectin-4 ADC) for urothelial cancer may gain approval.
    2019-07-20
    AMRN$400M offering
    2019-07-20
    SCPHFDA says no further clinical safety, efficacy, or pharmacology trials required. To resubmit NDA in mid 2020
    2019-07-20
    AVRO06.2018 IPO. Lentiviral gene therapy. Success in early trials of Fabry disease.
    2019-07-20
    BHVNdisappoints due to manufacturer Apotex problem affect bioequivalence study
    2019-07-20
    GILD$5B cash+equity deal with $GLPG galapagos. Why didn't I find this research powerhouse? then preclinical deals with $NVS
    2019-07-20
    BGNE

    deal in 2017 popped stock to $220. Now cool off, BMY dismissed PD1 deal, $172M/Q cash burn, 1.6B cash ~9 quarters, need to raise cash in 2020, to fill gap at $55.

    王婷:CMO keep changing, manufactured outsourced, will have supply problem, too many trials, PD1 approval keep delayed ...

    4 CMOs immuno-onco: 2015, 2016 (interim), 2016, 2019

    2019-07-19
    AGRXPrevious Chief Commercial Officer Renee Selman (07.2016-06.2018) left in 2018 during the cash saving lay off, now appointing new CFO with commercial experience Dennis P. Reilly from Invisible Sentinel, Inc., sold to BioMeriux, a French biotechnology company. All previous 3 small companies were sold.
    2019-07-18
    ABUSReplicor shown 04.10.2019
    Transaminase flares are rare during natural course of infection or with approved therapies
        - Safe and correlated with declining HBV DNA, HBeAg seroconversion, HBsAg loss and functional cure
    During REP 2139/pegIFN therapy, flares are highly prevalent (96% of participants)
        - Not correlated with baseline HBV DNA, HBsAg, ALT or median hepatic stiffness
        - Occur in HBeAg negative, HBeAg positive and HBV / HDV co-infection
    In 98% of these cases (49/50) liver function remains unaltered
        - Flares are otherwise asymptomatic in patients with mild to advanced fibrosis
    HBsAg clearance during flares may define their prognostic value:
        < 3 log10from baseline (typically > 10 IU/mL): 61% HBV rebound, no functional cure
        > 3 log10from baseline (typically 1 –0.00 IU/mL): 97% HBV functional control / cure** With completion of th
    2019-07-17
    ABUS

    AB-506 data: NO SAE, 2.0-2.8 log DNA reduction, 2.4log RNA reduction, 4/24 Grade 4 ALT flares with 1 HBsAg/HBeAg reduction of 1.4log 2.0log. Not drug induced liver injury (DILI), Possible immune mediated. to do 28d in healthy volunteers to confirm flare reason. Next day: 10% sell on news on small volume. Data seen as "intriguing"

    ABI-H0731 no ≥3 grade flare. No new flare on treatment. No HBsAg reduction. About 2.0log RNA reduction, less on lower dose.

    2019-07-15
    Top60
    min Mcap 2.02B medium 3.86B
    $ADPT TCR sequencing 06.2019 IPO
    $MOR MorphoSys Antibody Partner of Xencor
    $CRON first cannabis listed on NASDAQ 02.2018
    $EBS a broad biologics company
    2019-07-14
    ETON2019 new IPO. Generic formulation company. Little information on technology platform. CRL EM-100
    2019-07-14
    AMRXa company put stock quote on front page. Indian background. slogan "make healthy possible". generic business. lower revenue guidance. Poor stock performance since 2015, down 90%+
    2019-07-14
    AMGN$NVS discontinues BACE1 inhibitor CNP520 for Alzheimer's prevention
    2019-07-14
    ITCImixed Ph3 results on lumateperone for major depressive episodes associated with Bipolar I or Bipolar II disorder. Down 17%
    2019-07-14
    Elysium8 nobel prize winner advisory board, flop?
    2019-07-14
    HOOKHookipa engineered ArenaVirus to deliver tumor antigen to DC to induce anti-cancer immune response. IND cleared for HB-201 HPV-positive cancer. Lots of buzz word "supercharge" "nobel prize". Flop?
    2019-07-14
    SLGLSol-Gel silica microencapsulated drugs for slow release to overcome side effects of drug direct contact. Released successful Epsolay microencapsulated benzoyl peroxide cream, for the treatment of papulopustular rosacea
    2019-07-14
    ILMNrevenue miss, guidance lower due to array business weak. down 17%
    2019-07-12
    Biotechreview BIIB/CELG/GILD/AMGN/REGN historical P/S ratio, at low level
    2019-07-11
    TSLAmight have topped, triple top break down $250, find support at $175, bounce back in small volume, to fill gap at $38?
    2019-07-11
    EYEN

    share price ran down sharply to $3. Anticipated raise come 3 days after my reading. Priced $2.78 for $12.2M proceeds (need to raise again in half year?)

    option fully exercised increase to 5.05mil shares, net proceeds $13.0M
    2019-07-10
    ACRXCredit Suisse initiated with $7 target. up 10%
    2019-07-10
    EYEN

    finished reading 10K FY18. Great products, same efficacy, less side effects, more convenience and tech assisted compliance, microStat+microTears 2020 -> microProst for IOP lowering 2021 -> MicroPine 2023

    01.30 - 02.25.2019 MIST-1,2 success to file NDA for mydriasis in 2020, one year delay due to manufacture batch stability data requirement.

    expand microProst to CACG OAG OHT patients. The only with all three.

    Management experienced. CEO Sean Ianchulev, MD MPH Key.

    Next miles stone: microTears reg, MicroStat NDA 1Q20, Approval 2H20, launch both MicroStat and MicroTears 2021, MicroProst results 1H23.

    only 14.3 mil left (2 quarters of cash burn), need to raise capital soon.

    Founder Fredric Eshelman, co-founder Sean Ianchulev.

    2019-07-07
    CRVStargeting Adenosine-Cancer Pathway tumor -> adenosine -> AA2R on T cells
    2019-07-06
    UMRXAntibody coupled T cell receptor ACTR (CD16 Fc domain + 4-1BB + CD3z) + Rituximab for r/r CD20+ B cell NHL. FDA put on clinical hold after severe adverse event. I feel CD16 Fc not a good safe strategy.
    2019-07-06
    AMRNincrease revenue guidance and up sales efforts
    2019-07-06
    KPTIselinexor, FDA compromised with a conditional approval as 5th line therapy for RRMM after AdCom and PDUFA delay. Continued approval will depend on Ph3 results
    2019-07-06
    HanmiKorean pharma company, full of failure and scandals, big pharma ends all deals
    2019-07-04
    ABUSsold royalty to OMERS for $20m. Will revert back after $30m. 1.00-2.33% LNP licensing + undisclosed Acuitas royalty not included. extend 1 quarter cash burn
    2019-07-02
    ACRXadded to Russell 2000 & 3000 indexes
    2019-07-01
    ABUShearing transcripts out
    2019-07-01
    Semmaanimal studies in primate and pig show their device protected stem cell-derived islets. Clinical trial next step
    2019-06-30
    SRPTup 17% $PFE PF-06939926 AAV9 mini-dystrophin had 1/6 patient had severe antibody response
    2019-06-30
    CNATnew failure emricasan in NASH cirrhosis. quit. CTS-2090 pipeline caspase 1 inhibitor. $NVS Novartis had $50 upfront deal.
    2019-06-30
    NERVsuccess Phase 2b seltorexant (MIN-202) for insomnia. chart not so interesting. Better than Ambien. marketing challenge.
    2019-06-30
    KRYS

    KB103 (bercolagene telserpavec) topical gene threapy, for Recessive Dystrophic Epidermolysis Bullosa, or RDEB. Ph2 success. 5/6 wound closed. Raise $100M. A topical gene therapy company with STAR-D platform for skin gene therapy. KB105 IND initiated for TGM1-deficient ARCI. 2017 IPO at $10. Very successful so far.

    2019-06-30
    ACERFDA CRL on EDSIVO™ (celiprolol) for vEDS. additional trial required. It was repurposed on market beta blocker drug originally developed for hypertension.
    2019-06-30
    ACRSATI-502 JAK1/JAK3 Inhibitor Topical failed Alopecia areata, an autoimmune disease that results in partial or complete loss of hair.
    2019-06-30
    DOVABack up trend after FDA approves sNDA. Avatrombopag (Doptelet) oral asmall-molecule thrombopoietin receptor (c-Mpl) agonist. Approved May 2018, low revenue, management shake off in December 2018. Need to read more about commercial progress.
    2019-06-30
    ONCS1-to-10 reverse split after PhIIb failure. Deal the Dana Farber on bispecific CAR-T
    2019-06-30
    ZGNXResubmit Fintepla (ZX008) without the inclusion of the new chronic toxicity studies discussed with the FDA a root cause analysis to explain the incorrect clinical dataset
    2019-06-30
    ABUS$SCYX SCY995 NTCP receptor inhibitor against HBV entry
    2019-06-29
    P/C42 <=1; 130<=2 ( 519 biotech only)
    2019-06-28
    ACRX

    more insider buy small amounts. increased authorized shares to 200M from 100M, hopefully they don't need that much. up 20%. REF

    found another approved product Roxybond, no sales info so far. Yahoo board very negative, too many bashers
    2019-06-28
    CHMAOPTIMAL trial results now expect mid Q3; MPOWERED trial 2H2020; added to Russell 3000
    2019-06-28
    DVAXTLR9 actually protects mice from cardiac rupture after myocardial infarction in mice independently of inflammation.
    2019-06-27
    ACRXread about abuse concerns and REMS
    2019-06-27
    BiotechGottlieb goes of BOD $PFE Pfizer
    2019-06-27
    BigPic

    FED cool off rate cut expectation. Sell off good economy
    FINRA margin debt is healthy. down 3.4% in May

    2019-06-25
    ABUS

    listen to JMP fireside chat, AB506 no HBsAg, 729 once monthly, 452 hope, oral PD1L to boost immune response in some patients (antibody may be too long PKPD with side effects). Small molecule PD1 inhibitors, Immunotherapy review, PD1 -HBV human trial 9-14% sAg response PPT

    2019-06-25
    ABBVbuy Allergan 63B deal: 1 $AGN worth 0.8660 AbbVie and $120.30 in cash. Analysts pessimistic no synergy. Was $PFE target Peak $330 in 2015. Drop to $114.
    2019-06-25
    AGRXAdCom meeting scheduled for 10.30.2019. Sell on news to fill the 90c gap? Yes, down next day.
    2019-06-24
    ABUSread about motion to strike arguments. still confusing. new broad argument theories, no time to test and reply. Morgan Chu was lately recruited to represent $MRNA. Unconfident?
    2019-06-22
    MLNTFDA accepted sNDA for Baxdela in community-acquired bacterial pneumonia (CABP). PDUFA October 24, 2019. +198%
    2019-06-22
    ARCT LUNAR mediated delivery of RNA into cells. Expand deal with Ultragenyx $RARE discover and develop mRNA, DNA and siRNA therapeutics $6m upfront 2.4m shares at $10 equity investment
    2019-06-22
    OCULFDA approved sNDA for Dextenza in ocular inflammation following ophthalmic surgery. Well before PDUFA 11.10.2019
    2019-06-22
    AMAGVyleesi (licensed from Palatin $PTN) approved by FDA for hypoactive sexual desire disorder (HSDD) in premenopausal women.
    2019-06-22
    BYNDBeyond Meat plant based meat los angeles based. IPO $25. reach $201. 700%+
    2019-06-20
    ABUSAB-729 to initiate Ph1 after revising protocol, up 60%
    2019-06-20
    BHVN$300 mil offering wipe out buyout speculation, 30% and 1b market cap
    2019-06-18
    BigPic

    Xi Agrees to "extended meeting" Trump at G20, market break out upwards. I was right. Decline in fear, rise in news. #FTD Follow through day.

    2019.6.29 Truce agreed. Continue to talk. Future up 1%.
    2019-06-18
    Y--95%

    $SLS Galinpepimut-S (NeuVax) cancer vaccine failure on failure

    $INSY bankruptcy lawsuit and fraud
    $IMUX no proper PR on 09.2018 event
    $TNXP failed Ph3 for PTSD in 07.27.2018
    $JAGX strange GI product
    $MLNT see log


    mostly junk companies
    2019-06-17
    Y+300%

    $CRMD see log Neutrolin a non-antibiotic anti-infective for catheters.

    $CHMA my watchlist anticipating pending Ph3 results

    $AMRN same catalyst and flat since last watch

    $AXSM see log:  AXS-05 success. chiral chem, metabolism combo, carrier chem. neurology drugs

    short list, poor sector performance.

    2019-06-17
    AGRXCEO 20,000 shares 6.10.2019 #insider
    2019-06-17
    ACRXCEO bot 5,000 shares 6.5.2019 #insider
    2019-06-17
    VYGR$SNY sanofi give up rights to Parkinson’s disease program after FDA refused to review Ph2 and demand Ph3 trials. Still up 10% on $ARRY news
    2019-06-17
    ABUSWilliam Collier (age ~60 undergrad 1978-1981)  from VIIV Healthcare to replace Mark Murray as President and CEO, too bad I don't have new cash to add
    2019-06-17
    BGNE$BMY terminated $CELG PD1 deal with $150m fee
    2019-06-17
    VBIV$DVAX competitor fails 2 dose secondary endpoint succeeds higher protection rate, esp in diabetes smokers
    2019-06-17
    ARRY11.4B deal by $PFE 62% premium
    2019-06-17
    INSYfiles bankruptcy
    2019-06-15
    CBAY

    PPAR agonist seladelpar for NASH failed to reduce liver fat. -45% . Biopsy pending in mid 2020. Competitive landscape crowded. $GNFT also has PPAR. $ICPT Obeticholic acid (OCA) targets Farnesoid X receptor (FXR) better for now. $MDGL

    2019-06-15
    ACHVmissed 1 of 4 arms in Ph2 trials. Down 32%. Achieve Life Sciences bring Cytisinicline to US, a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. established smoking cessation treatment in Central and Eastern Europe 20+ years.
    2019-06-15
    SYBX$80m equity investment from Ginkgo Biowork. Company Designing Synthetic Biotic™ Medicines. SYNB1020 converts ammonia to arginine
    2019-06-15
    SVRA

    Molgradex an inhaled formulation of recombinant human GM-CSF, failed to spur significantly improved treatment outcomes for patients with a rare respiratory disease called autoimmune pulmonary alveolar proteinosis, or aPAP. Management tout patients reported life quality improvement.

    Other pipeline: inhaled vancomycin and other antibiotics
    2019-06-15
    PRVB

    teplizumab Ph2 type I diabetes success, median 2 year delay in high risk children and adults. up 169% week. binding of PRV-031 to CD3 triggers events that differentially inhibit the activation of self-reactive T cells, without affecting regulatory T cells. This restores the important state of immune tolerance and may prevent self-reactive T cells from attacking beta cells in the pancreas. If administered shortly after T1D diagnosis, PRV-031 has the potential to intercept the T1D disease process and slow or prevent the complete destruction of insulin-producing pancreatic beta cells.

    2019-06-15
    ARQLARQ531 more success overall response rate (ORR) of 66% (4 responses in 6 evaluable patients) in heavily pretreated relapsed or refractory chronic lymphocytic leukemia (CLL).
    2019-06-15
    CPRXsue FDA for bowing to drug pricing pressure
    2019-06-12
    DVAXClinicalTrials.gov update SD101 and DV281 trials now active not recruiting. Planned cohorts scraped.
    2019-06-11
    ABUSReplicor presents final REP 401 data demonstrating persistent functional cure (40%) of HBV, 43% functional control. So the strategy works.
    2019-06-10
    XERSa formulation company. The solutions or suspensions formulated using our technology have high stability and solubility. NDA of Gvoke (ready-to-use glucagon injection) by three months to September 10, 2019. -22%
    2019-06-08
    IFRX

    first-in-class antibody targeting the complement activation product C5a failed Ph2b IFX-1, in moderate to severe Hidradenitis Suppurativa (HS) 化脓性汗腺炎 down 91%
    $CCXI fall 23% developing similar avacopan (CCX168) for HS. Avacopan is an orally-administered drug candidate that inhibits the complement C5a receptor, or C5aR.

    2019-06-08
    MTFBFDA formally demanding additional trials for iclaprim ABSSSI after CRL
    2019-06-08
    BHVNcancel Goldman Sachs Global Healthcare conference. speculate company sale coming
    2019-06-08
    LJPC

    LJPC-401 in patients with hereditary hemochromatosis (HH) met Ph2 interim. up 139%. synthetic human hepcidin. Hepcidin, an endogenous peptide hormone, is the body’s naturally occurring regulator of iron absorption and distribution. In healthy individuals, hepcidin prevents excessive iron accumulation in vital organs, such as the liver and heart, where it can cause significant damage and even result in death. La Jolla is developing LJPC-401 for the potential treatment of iron overload, which occurs as a result of primary iron overload diseases such as hereditary hemochromatosis (HH), or secondary iron overload diseases such as beta thalassemia, sickle cell disease (SCD) and myelodysplastic syndrome (MDS)

    2019-06-08
    AMGNAMG-510 KRAS G12C inhibitor 5/10 PR, ORR 50% up 3.4%. $MRTX MRTX849 up 47%
    2019-06-08
    BigPic

    the sharp decline looks scary. After careful review, I don't think the market has peaked or a bear is coming. So many stocks has been consolidating for years. Sharp decline of ABUS ACRX DVAX are scary but too sharp to last.

    2019.06.10 update: $INDU a follow through day, a bullish Kilroy consolidation. Consolidation is driven by threat of trade-war. Will be solvable.

    2019-06-07
    AGRXinitiated at Oppenheimer target $5 citing regulatory box checked, potential to expand patch market
    2019-06-07
    Portfoliodown -51%, loss $51k, overall loss $75k. Had profit with ABUS 200%, DVAX 100% ACRX 60% AGRX 20%.
    reduce debt, raise cash when 1) high 2) at resistance 3) gap behind, exhaustion gap ($DVAX) 4) negative news could come 5) positive expectation may not come especially for $DVAX and $ABUS
    2019-06-06
    AGRXexpect AdCom announce ment in July-August for a September-October meeting
    2019-06-06
    BigPica little panic today after $ACRX liability problem. $CPC #GapIndex reaching climax, $VIX still calm.
    2019-06-03
    DVAX

    2mg ORR improved from 70% to 76% (34/45) with 8/45 CR (18%). 2mg 18m PFS 72%. $BMY perhaps can buy SD-101 and combine with NKTR-214 that has excellent CR but mediocre ORR.

    2019-06-03
    ACRX25mil new debt including payment of 9mil old debt; I am seriously concerned about failure of Zalviso in Europe and its consequences (bankruptcy).
    2019-06-03
    NKTRresponse remains 53% but 4 new complete response (13/38). really deepening response. up 12%
    2019-06-03
    BMRNthree-year data from its Phase 1/2 trial of valoctocogene roxaparvovec, for adults with severe hemophilia A. efficacy still impressive with durability dropping
    2019-06-01
    AMRNVascepa (icosapent ethyl) pure EPA Omega-3 derivative priority review for sNDA
    2019-06-01
    KZRKzr-616, a selective inhibitor of the immunoproteasome, blocks the disease progression in multiple models of systemic lupus erythematosus (SLE). Both safety and efficacy data were disappointing. two healthy volunteers who received the 60 mg dose required hospitalization
    2019-06-01
    CARACR845 Kappa Opioid Receptor Agonists (KORAs), provide pain relief (peripheral opioid analgesia) without producing significant CNS and mu-opioid mediated side effects. met the primary endpoint in its Phase 3 KALM-1 pivotal trial of Korsuva in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP)
    2019-06-01
    ZFGNZGN-1061 (METAP2 inhibitor) clinical hold still after type A meeting with FDA, working on animal model
    2019-06-01
    DVAXdisappointing SD-101 in HNSCC 24% ORR 2mg worse than 8mg barely better than PD1 alone, poster says "not mature", many had only one scan, but not on-going. May not improve over time.
    2019-06-01
    AMGNPorges praise KRAS:G12C program
    Moderna has mRNA-5671 for KRAS mutation mRNA vaccines
    JNJ team with wellsprings (Yi Liu San Diego) for small molecule KRAS:G12C inhibitor
    2019-05-29
    ASCO

    Brad Loncar preview ASCO19:
    1. $IOVA cell therapy TIL works in solid tumor (cervical cancer)
    2. $MGNX antibody Fc engineering works vs Herceptin anti-Her2
    3. $AMGN rises in oncology with BiTE and KRAS G12C inhibitor
    4. $MRTX KRAS G12C rise on $AMGN news
    5. Precision medicine: NTRK, RET, PDGFRA, KIT mutations.
    6. Immunotherapy offers long term benefit, trial follow up updates
    7. $NKTR provide better response after longer follow-up?
    8. BiTE: CD3 popular, cytokine release storm still a problem, PD1xCTLA4
    9. Antibody conjugate: Immunomedics, Seattle Genetics/Astellas, ImmunoGen, Mersana
    10. $CELG JCAR017 why delays
    11. PARP inhibitors expand use?

    2019-05-28
    Biotechexecutive sentiments lower, but not yet the worst
    2019-05-28
    Biotechtop 10 blow off of 2H18
    2019-05-28
    NKTRspin out opioid, may not be as successful as touted
    2019-05-28
    ACRXadd 617@$2.628, $1621.5. Gap filled.
    2019-05-28
    TOCAIndependent Data Monitoring Committee (IDMC) recommended that its Phase 3 Toca 5 trial evaluating Toca 511 and Toca FC in patients with recurrent high-grade glioma (HGG), to continue through to final analysis. Investors had hoped that the trial would be stopped due to sufficient efficacy. Shares closed the week down 48% to $4.59 on the basis the lack of efficacy in the interim analysis will also be reflected in the final analysis due towards the end of this year.2019-05-26
    OCULmy old target, did very poorly ever since. failed Ph3 OTX-TP, for the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension
    2019-05-26
    BCRXoral BCX7353 for the prevention of hereditary angioedema (HAE) attacks, less efficacy than expected, may not be competitive. Was $IDRA merge target
    2019-05-26
    ARRYBraftovi (encorafenib), Mektovi (binimetinib) and Erbitux (cetuximab) for colorectal cancer, met OS and ORR
    2019-05-26
    NVSFDA approved Zolgensma, the first gene therapy for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA). Novartis will price Zolgensma at $2.125m, or an annualized cost of $425,000 per year for five years.2019-05-26
    DVAXI want to add that these SD-101 trials are the "only" trials Dr. Antoni Ribas is presenting at ASCO19. He is a big name in immunotherapy. He just got elected president-elect at AACR. Like you said, I wish he does not go to ASCO19 just for the embarrassment.2019-05-25
    BGNE178 mil quarterly R&D ... waiting for gap fill around $50
    2019-05-24
    DVAX$175mil loan was a red flag, no partnership for 1.5 years, could not raise enough by offering. High debt is bad.
    2019-05-24
    AGRXresubmission accepted in 5 days. PDUFA 11/16/2019. 6 months review. Potential AdCom in August to October
    2019-05-23
    ABUSnear cash again if not considering convertible notes. Sentiments very negative. oral argument 6.6.2019
    2019-05-23
    DVAX

    divest immuno-oncology programs to focus on vaccine business, CEO Eddie Gray to retire. Layoff 37% staff.
    so they know ASCO results already?
    $MRK Keytruda failed Ph3 TNBC against chemo
    Not too bad. Uncertainty gone. At least we have a proved product.

    2019-05-23
    MRK$1.05b for Peloton Therapeutics, $1.15b milestones. PT2977 targets hypoxia-inducible factor-2α (HIF-2α). Big Deal overdue
    2019-05-22
    MGTXPh1/2 dose escalation of AAV-RPE65, for the treatment of RPE65-deficiency, a condition that causes blindness, success
    2019-05-20
    INSYopioid company INSYS pending bankruptcy due to opioid market (fentanyl) decline and lawsuits
    2019-05-20
    IMGNFDA has requested the company conduct a new Phase 3 trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with ovarian cancer. Its previous FORWARD I trial did not meet the primary endpoint.2019-05-20
    MYOV Ph3 relugolix for uterine fibroids met its primary endpoint, but shares -28% due to Abbvie Elagolix competition
    2019-05-20
    ADVMDA lifted clinical hold on ADVM-022 for 2nd cohort in its Ph1 for wet age-related macular degeneration (wet AMD).2019-05-20
    DVAX$6 gap closed
    2019-05-20
    AGRXresubmit Twirla. no pop. -3.42%. Get ready for next week
    2019-05-17
    ASCO

    $IOVA 44% ORR for its TIL therapy LN-145 in 27 evaluable cases of advanced cervical cancer
    $GILD  resolving cytokine storms for CAR-T patients
    $MGNX FC engineered anti-HER2
    $AMGN $MRTX collaboration KRAS G12C inhibitor OK efficacy

    2019-05-16
    DVAXabstract old data except 2mg HNSCC encouraging: 2CR 3PR (n23) at first scan vs 8mg 6PR (n22) multiple scans2019-05-15
    ISEE$OPHT rebranded to IVERIC BIO to focus on gene therapy. No reverse split yet.
    2019-05-11
    AXSMsubstantial gain after AXS-05 success. chiral chem, metabolism combo, carrier chem. neurology drugs hard to understand
    2019-05-11
    FGENroxadustat, for anemia in chronic kidney disease (CKD), "no clinically meaningful difference in risk of MACE between roxadustat and epoetin alfa". So not safer than SOC
    2019-05-11
    QUREmore promising data on Phase 2b AMT-061 for severe and moderately severe hemophilia B
    2019-05-11
    CPRXFDA to approve Ruzurgi by Jacobus Pharmaceutical Company for Lambert-Eaton myasthenic syndrome (LEMS) in children. $CPRX competitor
    2019-05-11
    FLXNZILRETTA is an extended-release corticosteroid approved to manage osteoarthritis knee pain. It is not intended for repeat use. approval from the U.S. Food and Drug Administration on October 6, 2017 and the company initiated the full commercial launch on November 20, 2017. Similar time to Heplisav Q4 2017: 0.36M 2018 revenue: 2.2 3.8 7.0 9.5; 19: 10.6
    2019-05-11
    PBYIearnings miss 46m vs 66m estimate
    2019-05-11
    ABUS

    online article on patent dispute: PTAB has not yet made any final decisions, and it has explicitly reserved certain highly material factual issues for later determination.  The IPRs thus remain worth watching.

    2019-05-09
    BigPic

    US-China talk may not reach a deal; Fed may step in, yet will be disaster; Trump will be re-elected

    Update 5.10: talk continues with 25% tariff on.
    2019-05-09
    ABUSread about CEO pay, top CEOs get 15-25 mil, Mark Murray got 500k salary + 1.6mil options
    2019-05-09
    DVAXread DV281 poster again, patients were pretreated, 20/23 were treated with PD1 or PD1 chemo combo.
    2019-05-09
    ACRX
    Zalviso resubmission by YE19, pending REMS and Europe data. No hospital declined. Diverse use. ERAS. ER efficiency: keep vertical, no witness needed for disposal leftover
    Q: ASC, 5 of 46 approval other ongoing, REMS not a problem for hospital. Non-invasive, flat PK, opioid shortage continues. Investigator initiated ERAS trial pending. Initial revenue mostly whole saler. Approvals came in April.
    2019-05-09
    ABUS
    We have performed a variety of studies in vitro to look for signs of toxicity or other off target effects. We cannot find them. The compound looks clean. We have knocked out several cellular proteins involved in the mechanism, there appears to be no deleterious effects on the cells. And finally we have made a competitive position in this space and we'd like to maintain that with the first RNA-destabiliser to the clinic.

    1. Changed Vehicle. "what I can say is that the vehicle we used was really somewhat unusual." - Sofia going standard vehicle
    these vehicles are - are only used in animal studies, they're not used in humans. We have solid dosage formulations for human studies. If we are able to move forward.
    2. AB729 package enough for healthy, wait study results for HBV patients
    3. AB506 not expecting HBsAg effect
    2019-05-08
    DVAXCC: 2-dose causes a hurdle for change: Protocols and EMRs, 2-dose needs to be marked as complete.
    no new oncology commitment before partnership deal by mid-year?
    new CKD study is to find the right dosing regime than new additional patients.
    ASCO: 2mg PD-1 resistant; 2mg HNSCC
    Inventory growing as demand grows
    557/1420 yes, 863 nos. Nos are small number, not permanent, some converts, we keep in touch. One had wrong price to P&T.
    2019-05-08
    DVAXsales slow, $30m covenant should easily met. Moving into new bigger office and lab space. 1, 2. 41k -> 76k sqft.
    2019-05-08
    ACRXQ1 minimal revenue. ambulatory surgical center network with over 300 locations. "On track"?
    2019-05-08
    RGLSNew private placement of equity, term loan restructure, $MGEN miRNA no signs of turning around
    2019-05-07
    IDRAAACR19 Tilsotolimod monotherapy data:  13/29 45% SD, 5 maximum tumor shrinkage >10%, duration of SD 1.3~9.7+ m
    2019-05-06
    DVAXnew Heplisav-B  trial on end stage dialysis kidney disease patients
    2019-05-06
    ABUS1Q19 CC PR: Delay, delay, delay ...
    AB-506 delayed from Q2 to July
    AB-729 delayed from Q2 to unknown
    AB-452 go/nogo decision delayed from H2 to early 2020. the nonclinical safety study resulted in several confounding observations which included clinical observations with no histological correlation, a lack of dose response regarding some key findings and an unexplained vehicle effect. Because of these confounding observations, we have determined that repeating the 90-day preclinical safety study in two species is appropriate before making a go/no-go decision.
    2019-05-06
    HRTXCMC & non-clinical CRL HTX-011 for the management of postoperative pain. Competitor $PCRX up
    2019-05-05
    NBRVCMC CRL of Contepo (fosfomycin) antibiotic for complicated urinary tract infections (cUTI).
    2019-05-05
    VTGNAV-101 failed phase 2 treatment-resistant depression (TRD). ketamine is a classic channel-blocking NMDA receptor antagonist. AV-101 is a NMDA receptor GlyB antagonist that inhibits NMDA receptor function rather than blocking it. We believe this difference (modulating NMDA receptor activity rather than blocking it), together with the activation of AMPA receptor pathways, can potentially bypass the adverse side effects that occur with ketamine while still achieving fast-acting ketamine-like antidepressant effects.2019-05-05
    MBRX
    a common example of a nano/mirco cap company announcing largely insignificant news, in the hope of garnering the attraction of day traders, and following it up with an offering to raise cash through the sale of shares and warrants, taking advantage of the price spike.

    Annamycin: The Next Generation Anthracycline for AML, and lung cancer mouse model. Other pipeline candidates MOA not clear/disclosed
    2019-04-27
    GRTS

    down 21%  to $10.79 offering 6.5m share @$11.50 $ABUS LNP licensee went IPO in 2018.11. work on neoantigens

    2019-04-27
    CTRVContraVir $ABUS competitor CRV431 cyclophilin inhibitor not doing well. Penny stock. Just offered 0.12 per share for total proceeds of $2.14m. $ABUS discontinued cyclophilin progam in Oct 2015. Promised a lot at 2015 for 2016, 2017, but significantly delayed now at 2019. cccDNA program in lead optimization
    2019-04-27
    RGENlong time ago they failed this target therapy. now back with C Technologies buyout, a biomanufacturing analytics company.
    2019-04-27
    ALKSschizophrenia drug, Aristada. Revenue disappoints of $30m v. guidance in February $40m. down 13%
    2019-04-27
    ABUSgap filled
    2019-04-24
    PoliticsMD Anderson oust three Asian researchers due to foreign connections
    2019-04-24
    Biotechlate stage productivity is rising fast and most are due to emerging biopharma not big pharma
    2019-04-24
    RNN

    RX-1117 only activated by UCK2, high in tumor cells. then acts as nucleotide analog, kills that cell. Deal with BioSense China. Nano cap. Reverse Split.

    2019-04-21
    FCSCFCX-007 Col7 gene therapy small deal with Castle Creek Pharmaceuticals with 7.5mil upfront. Nanocap. Reverse Split.
    2019-04-21
    MBIOdata released in May 2018, published on NEJM. share price down 60% since data release, but up 112% for NEJM. Gene therapy cured XSCID "Bubble Boy" in 3-4 months.
    2019-04-21
    WVEPhase 2/3 patients will receive only 3 mg/kg or 4.5 mg/kg doses of suvodirsen, low dosage too low to show sufficient efficacy and higher doses not possible due to safety.2019-04-21
    ABUScombo strategy is not a reason for price unless proven by data. LNP deals did not come as expected.
    2019-04-19
    ASMBcore-inhibitor ABI-H0731 show 2.x log HBV DNA RNA reduction, but no HBeAg HBsAg reduction
    2019-04-19
    Immune-onco‘Patients are not a company’s resource’: FDA cancer czar Richard Pazdur warn top R&D execs; call for collaboration, reduce harm and waste
    2019-04-18
    Biotechhealthcare sector crashing today despite new high in big market; made the right decision to wait for gap fill; "Medicare for all" scares healthcare sector
    2019-04-17
    Biotech#FDA acting commissioner Ned Sharpless not playing with the FDA’s gold standard, continue Gottlieb's policy
    2019-04-17
    AKAObankruptcy, no revenue half year post approval. Was a $2B company. Antibiotics is a bad business
    2019-04-16
    AMGNEvenity price $21,900/y, compete on monthly dosing and 1 year course; Cons: high CV risk, non-vertebral reduction soso
    2019-04-16
    UTHRlicensed from Lung Biotechnology esuberaprost Beraprost 314d modified release (BPS-314d-MR) is a single isomer prostacyclin analogue oral tablet. Miss Ph3 endpts in pulmonary arterial hypertension (PAH)
    2019-04-13
    TCONTRC105 (carotuximab) antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis. Phase 3 TAPPAS trial evaluating TRC105 in combination with Votrient (pazopanib) in patients with advanced or metastatic angiosarcoma was terminated for futility. Other TRC105 trials terminated.
    2019-04-13
    Insider
    $DVAX 200k shares sold in last 3month
    $ABUS quiet
    $ACRX heavy buying from all officers around 2.7~2.9 in Feb
    $AGRX Buying by 2 insiders on 3/29/2019, multiple options executions
    2019-04-13
    WVE

    a delay in readouts from its two ongoing Phase 1b/2a clinical trials evaluating WVE-120101 and WVE-120102 for patients with Huntington’s disease (HD). 1 month ago says this quarter, now delayed to YE. Poor enrollment. Both drugs are antisense oligonucleotides (ASO) against HTT gene

    2019-04-13
    ZGNXFintepla (ZX008) refused to file. dataset missing or incorrect
    2019-04-13
    PHASBTD for PB2452, a reversal agent for the antiplatelet drug ticagrelor2019-04-13
    CMRXantiviral medicines for patient with weakened immune systems. got Michael A. Sherman, former CEO of Endocyte
    2019-04-13
    BHVNexploring a sale of the company, oral CGRP inhibitor, $AMGN $NVS Aimovig doing well
    2019-04-13
    SBPHInarigivir Ph2 results 1.5log DNA reduction 1.1 log RNA reduction, 26% see >0.5 log HBsAg reduction with a mean of 0.8log. select 400mg for Ph3
    2019-04-12
    DVAXHDAC inhibitor poster
    2019-04-11
    BGNEdeal with San Diego-based BioAtla BA3071, a CTLA-4 blocking “conditionally active biologic” that gets turned on or off based on whether it’s inside the tumor microenvironment.
    2019-04-09
    AMGNRomosozumab (Evenity) FDA approval despite CV risk
    2019-04-09
    AMGN$NVS breach partnership by partnering with Alder
    2019-04-08
    Immune-oncoexosome carries PD-L1 away
    2019-04-08
    CRL Rev
    $MNK FDA Rejects Mallinckrodt’s Abuse-Deterrent Opioid Painkiller MNK-812
    $MTFB $ADMA $IMMU $ALKS $TRVN $AQST $LXRX $REPH $EVOK
    2019-04-06
    EASL
    $SBPH Inarigivir RIG-I $ASMB core inhibitors cccDNA inhibitors $ALT HepTCell
    2019-04-06
    MACKMM-310, EphA2 receptor targeted nanoliposome Docetaxel ADC, discontinued for solid tumors
    2019-04-06
    REPH50% reduction in employees
    2019-04-06
    EVOKGimoti CRL, intranasal formulation of metoclopramide, for acute and recurrent diabetic gastroparesis2019-04-06
    ADMAFDA approved Asceniv (RI-002, 10% IVIG) for Primary Humoral Immunodeficiency Disease.
    2019-04-06
    SGMOup 32% to $12.58 interim data Phase 1/2 Alta trial SB-525 gene therapy for severe hemophilia A.
    2019-04-06
    ABUSsubmitted Objection to Evidence in patent dispute against Janoff's opinion
    2019-04-04
    DVAXDV-281 data not so exicting. There is no response (CR/PR) in 20 evaluable patients. The SD/PD ratio is the same as the before the treatment. So we don't know if DV281 did anything at all, or just PD-1 did its job.
    2019-04-02
    PTIProteostatis disappoints triple combination trial of PTI-428, PTI-801 and PTI-808, for cystic fibrosis.
    2019-04-01
    CANFCan-Fite fails Ph2 liver cancer. Gi protein coupled A3 adenosine Technology Platform - A3Areceptor (A3AR) is highly expressed in inflammatory and cancer cells. Company make A3AR agonists
    2019-04-01
    ALDXreproxalap (RASP inhibitor to reduce aldehyde) for allergic conjunctivitis met Ph3 primary endpoint.2019-04-01
    OSMTArbaclofen, or R-baclofen, acts upstream of the mGluR5 receptor to increase inhibitory neurotransmission. met just 1 of 2 endpts in 2nd Ph3 spasticity in Multiple Sclerosis (MS)
    2019-04-01
    FCSCpromising wound closure rates of 63% from its ongoing Phase 1/2 clinical trial of FCX-007, market sold on new.
    2019-04-01
    GLPG$GILD partner Phase 3 filgotinib (JAK1) in adults with moderately-to-severely active rheumatoid arthritis more success
    2019-04-01
    TCDATricida veverimer met Ph3 CKD. TRC101 is a novel, non-absorbed polymer that is designed to treat metabolic acidosis by binding hydrochloric acid in the gastrointestinal tract and removing it from the body through excretion in the feces, thereby decreasing the total amount of acid in the body and increasing blood bicarbonate
    2019-04-01
    PRTOvonapanitase fails Ph3 CKD. Exact mechanism unknown, perhaps vonapanitase fragments elastin fibers in the vessel wall and thus may augment endogenous elastase activity in the fistula.
    2019-04-01
    DVAXEMA Heplisav-B submission
    2019-04-01
    CHMAoffering 6.3mil shares at $4.75
    2019-04-01
    REPHIV meloxicam for pain, 2nd CRL
    2019-03-24
    LXRX$SNY SGLT2 SGLT1 dual inhibitor sotagliflozin CRL after 8-8 split AdCom
    2019-03-24
    UROVPh3 vibegron for overactive bladder success. 220% pre-data release run, down 20% upon news
    2019-03-24
    SAGEZulresso (brexanolone) injection for postpartum depression (PPD). Approved.
    2019-03-24
    CNATfails biopsy-confirmed nonalcoholic steatohepatitis (NASH) and liver fibrosis
    2019-03-24
    ARPOAKB-9778 a small molecule inhibitor of VE-PTP fails Ph2 non-proliferative diabetic retinopathy (NPDR)
    2019-03-24
    DERMPhase 2b lebrikizumab (anti-IL13) for atopic dermatitis success. to compete IL-13/IL-4 drug Dupixent Regeneron/Sanofi
    2019-03-24
    DVAXExtensive SD-101 clinicaltrials.gov registration update 4 new cohorts Q3W dosing match Keytruda. Previously weekly2019-03-24
    BIIBAlzheimer’s drug aducanumab implodes in a PhIII disaster; but Eisai still believes it
    2019-03-22
    SPPIwithdrawn its Biologics License Application (BLA) for Rolontis (long acting G-CSF), compete Neulasta
    2019-03-17
    MCRBSeres got $20M equity investment from $AZN 's immuno-oncology deal
    2019-03-17
    ZFGNsuspend IND ZGN-1258 (MetAP2 inhibitor), for rare metabolic disorders including Prader-Willi syndrome (PWS) due to tox
    2019-03-17
    AERIRocklatan 0.02%/0.005% to reduce elevated intraocular pressure (IOP)  approved, no big change
    2019-03-17
    KPTIselinexor, for relapsed refractory multiple myeloma, PDUFA extended by three months to July 6, 2019.
    2019-03-17
    ATOSAtossa Genetics Inc. misleading PR: making a 1-patient expand access approval sounded like marketing approval, up 400%
    2019-03-17
    BioNTechto IPO raise $800mil with $4B valuation #Genevant $ABUS
    2019-03-12
    BiotechNCI’s Ned Sharpless to run the FDA in wake of Scott Gottlieb’s surprise exit; expect favoring policy to continue
    2019-03-12
    AMAGHydroxyprogesterone caproate (OHPC), (Proluton and Makena), progestin to prevent preterm birth miss Ph4
    2019-03-10
    EVOKGimoti, intranasal formulation of metoclopramide, for acute and recurrent diabetic gastroparesis2019-03-10
    ASNDAscendis once-weekly TransCon hGH success Ph3 in pediatric growth hormone deficiency (GHD) v. Genotropin $OPK
    2019-03-10
    ARQLARQ531 Ph1 success in B-cell Malignancies. BTK inhibitor designed to inhibit both wild type and C481S-mutant. FY18 CC
    2019-03-10
    SEELseelos nano cap in-licensed peptide inhibitors of alpha-synuclein for Parkinson. Rise in speculation
    2019-03-10
    BPTHPrexigebersen (Liposomal Grb2 Antisense) for Acute Myeloid Leukemia (AML) show promising Ph2, plan to file NDA
    2019-03-10
    ACRX

    FY18 CC launched Jan-Feb. expected formulary approval 100->125, accelerate Q4 sales hiring to Q3. Manufacture automation cost reduction and consolidation of Zalviso will help ex-US licensing. Zalviso US prident wait for REMS and more EU data for compliance and abuse. Sales team experienced, Physical therapy and burn patients, military talking, Enhanced recovery after surgery ERAS, timing P&T, embrace REMS

    2019-03-07
    ABUS

    FY18 CC, AB-506 Ph1b data due Q2, AB-729 Ph1 Q2-Q419, AB-1467 discontinued. owns 40% Genevant. 85m shrs. Commit to RNA destablizer, take time to complete; Onpattro royalty nonmaterial this year, open to deal

    2019-03-07
    ONCEbidding from 70 - 73 cutoff collab talk - 75 B - $450M C, upfront - 84 C - 91 Roch final - 105 C final - 114.5 Roche back
    2019-03-07
    ALNYpromising top-line Ph3 snapshot for givosiran for acute hepatic porphyria, but safety issues. Risk/Benefit?
    2019-03-07
    BiotechPopular #FDA ccommissioner Scott Gottlieb has handed in his resignation
    2019-03-05
    ACRXflash crash bear raid, I resisted the tempt to look twitter for explanation. 25% intraday spread
    2019-03-05
    NextCureLieping Chen's new company. immune suppressor Siglec-15 (S15). Targeting S15 to overcome PD1 resistence
    2019-03-05
    BIIBbought $NITE Nightstar Therapeutics 800M for rare inherited eye disease gene therapy, each could generate 100-200M/y
    2019-03-04
    AGRXPrivate placement 8.4mil shares at $0.93 raise 7.8mil, no discount, confidence, total 43.5m shr. Target 60M, $40/share?
    2019-03-04
    KPTIAdCom 8-5 recommend wait for Ph3 results selinexor for relapsed or refractory multiple myeloma, citing toxicity
    2019-03-02
    NVAXResVax RSV-F vaccine failed in pregnant mothers to protect infants  39-48% protection severe consequences
    2019-03-02
    HZNP

    Horizon Pharma teprotumumab (anti-IGF-1R) for active thyroid eye disease (TED) met its endpoint, autoimmune inflammatory disorder: eye muscles and fatty tissue behind the eye become inflamed.

    2019-03-02
    TGTXTGR-1202 umbralisib (PI3Kd inhibitor) meet ORR in MZL Ph2b
    2019-03-02
    IMGNImmunoGen mirvetuximab (anti-folate receptor alpha FRa) soravtansine IMGN853 ADC failed PFS for ovarian cancer. Endocyte/Merck vintafolide and Eisai’s farletuzumab have suffered the same fate.
    2019-03-02
    LXRXsotagliflozin CHMP positive opinion after AdCom 8-8.
    2019-03-02
    PBYIBack on track with Nerlynx Sales improvement 4Q from 20m to 60m
    2019-03-02
    ADROStrategic reset to focus on core strength: STING APRIL. Deprioritize CTLA4 SIRPa pLADD
    2019-02-28
    DVAX#AACR19 domatinostat (4SC company) SD-101 combo further boosts response in mouse model
    2019-02-27
    BMY8% stake largest shareholder Wellington oppose merger with $CELG 1) offering $BMY at too low price 2) execution harder than mgmt imagine 3) alternative way to create value.
    2019-02-27
    DVAX

    down -10%, sentiment bearish; Nothing fundamental has changed. $DVAX still has the best I/O combo in clinic. Heplisav still the best Hep-B vaccine - improves response with 2-dose/1-month. TLR still the Nobel prize winning pathway that started the whole concept of "innate immunity". It seems all about business for now; science will prevail eventually. $IDRA is flat; so today's selling is mostly speculators selling on news. Nothing about TLR9.

    2019-02-27
    DVAXFY18 CC: 1. not suitable for younger patients, no plan; 2. partnership deal pending 2mg data in HNSCC and Melanoma R/R trials 3. Q1 revenue could still be disappointing 4. lots of plan: EU, Pertussis, I-SPY2, HPV tumors, DV281 AACR
    2019-02-27
    DVAXCould $GSK be the long sought partner for $DVAX SD-101 program, given CEO Mr. Eddie Gray's tie with GSK?2019-02-26
    ICPTPhase 3 trial of obeticholic acid (OCA) with liver fibrosis due to nonalcoholic steatohepatitis (NASH) meet fibrosis but not NASH resolution endpoints
    2019-02-25
    VYGRdeal with $ABBV AAV vectorized antibodies for Parkinson’s disease and other disorders of misfolded alpha-synuclein protein
    2019-02-25
    KPTIselinexor oral XPO1 inhibitor, FDA briefing, slam their case on the efficacy of a cancer drug with “significant toxicity”
    2019-02-25
    DHRDanaher to buy GE Life Sciences for $21.4B with $3B revenue
    2019-02-25
    CMTAClementia bought by $IPN Ipsen for upto 1.31B $25+$6CVR ($14.92previous close)
    2019-02-25
    BigPicTrade dispute to be resolved. It is all about negotiation. Nobody wants trade war.
    2019-02-24
    BMRN$2 million or $3 million per patient, 5000 pts per year capacity, $10-15B /year
    2019-02-24
    ONCE

    Roche to buy Spark gene therapy for $4.3B, 122% premium

    2019-02-23
    NTLAOctober 2018 data on LNP CRISPR+AAV gRNA $ABUS
    2019-02-23
    MRK$IMDZ $DVAX clearly $MRK IS interested in activating DCs via TLR pathway AND intratumoral delivery route. However, TLR4, is a mediocre TLR target comparing with CpG-TLR9.
     
    1. TLR4 is on cell surface, TLR9 is in the endosome
    2. TLR4 is less APC specific, TLR9 is DC specific.
    3. TLR4 is a poor interferon inducer, TLR9 is excellent IFN inducer.
     
    The first two points will lead to toxicity, and the last point may suggest inferior efficacy.
    2019-02-21
    XNCRCD3 bispecific antibodies run into trouble with toxicity $JNJ $MGNX
    2019-02-20
    ALNY

    Onpattro earnings
    4Q18 12.1mil
    19: 26.3mil 38.2mil

    2019-02-19
    MRKoverdue for a deal, last one was with $STRO, a discovery biologics therapeutic protein, ADC, BiSpecific company
    2019-02-17
    Clinigen$CLIN.LN acquired Proleukin original IL-2 rights from Novartis
    2019-02-17
    PassagePassage Bio got Penn and James Wilson for a startup AAV #genetherapy company after Wilson abruptly resigned from $SLDB
    2019-02-17
    DBVTplans to resubmit 3Q19 after withdrawal in 2018.12. $AIMT already under review
    2019-02-16
    CLBSCaladrius CD34+  and T-reg cell therapy. CLBS03 autonomous T-reg failed type 1 diabetes to protect recent onset residual beta cells
    2019-02-16
    MTFBpicked up failed drug ABSSSI antibiotic from Roche spinout Arpida in 2009, ran 2 Ph3 to show non-inferiority. FDA rejected again CRL, demanding liver toxicity data. Similar to $CEMP
    2019-02-16
    ACRXgap up on credit suisse coverage
    2019-02-15
    BigPicIPO market low, $WLSH $GapIndex break 200MA in rising volume
    2019-02-15
    AZNdropped pipeline anti-OX40 MEDI0562 and dual TLR7/8 agonist MEDI9197 (too toxic even designed to stay in tumor). $DVAX
    2019-02-14
    DVAXUsually announce CC 1 week ahead, This time announced 2 weeks ahead on 2.12 for 2.26 event.
    2019-02-14
    ABUSMore delays, still working on AB-452; AB-506 Ph1 data Q2. -4.88%
    2019-02-14
    Biotech

    drug pricing. Only 1 drug company ($JNJ) in fortune 50, mostly due to its consumer business. 3 out of the top 10 and 8 of the top 50 most successful businesses in the world based on total revenue are health insurers, PBMs, or drug distributors. drug manufacturers only receive 39% of initial gross drug expenditures

    2019-02-13
    GILDselonsertib (ASK1 inhibitor) fails Ph3 NASH $MDGL $VKTX
    2019-02-12
    MRKTKI/IO combo in Renal cancer; priority review for HNSCC
    2019-02-12
    ABUS#genetherapy AAV summary: AMT-061 liver FIX AAV5; SB-913 liver albumin promoter driven IDS AAV2/6; SGT-001 muscle microdystrophin AAV9.
    2019-02-11
    DVAXIntalere (group purchasing and logistics) signs volume purchase pricing agreement with $DVAX
    2019-02-11
    AGRXTwirla adheres non-inferior, potentially better than FDA approved Xulane.
    2019-02-11
    QUREAMT-061 update FIX level sustained up to 16 weeks after a single dose in all 3 patients. How durable is this in longer term? All 3 pts had pre-existing anti-AAV ab. No chance for redosing.
    2019-02-09
    SLDBDMD dad's Solid Bio disappointing data Ph1/2 dose-ascending SGT-001 microdystrophin gene transfer. Low expression. This week two setbacks in AAV gene therapy: Sangamo's SB-913 for MPS-II and Solid Bio's SGT-001 for DMD. Both suffer from poor efficacy. AAV does not work. low dose -> poor efficacy, high dose -> toxicity, repeat dosing -> immune response. AAV guru James Wilson quit. LNP gene therapy is the future.
    2019-02-09
    SGMOGene Editting disappoints, dragging down peers. Had immune response, AAV vector
    2019-02-07
    MGNXmargetuximab anti-HER2 met Ph3. Not much details.
    2019-02-06
    XNCR$160M IL-15 alliance with $RHHBY
    2019-02-05
    ACRX$PTIE gave up on Remoxy
    2019-02-05
    BMYActivist investor Starboard Value eyes on $BMY. may derail Celgene buyout and push for $BMY sale.
    2019-02-04
    GILDWrite down BCMA CAR-T, 900M, just the beginning of write downs 12B? Not enough revenue Yescarta despite first and best in class. Field moving on to off-the-shelf.
    2019-02-04
    ABUSLipid Nanoparticles Enabling Gene Therapies: From Concepts to Clinical Utility. (Nucleic Acid Ther. 2018)
    2019-02-02
    AQSTlicensee Sunovion got a CRL for apomorphine sublingual film for OFF episodes with Parkinson's disease (PD)2019-02-02
    ACIUAC Immune and Roche (RHHBY) is discontinuing Ph3 trials of crenezumab against human 1-40 and 1-42 Beta amyloid, for Alzheimer’s disease (AD)  $BIIB
    2019-02-02
    AVEOFDA rejects preliminary OS data VEGFR Tivozanib wait for mature interim OS data due 4Q19
    2019-02-02
    MGTX$100 upfront from Janssen ($JNJ) on AAV Gene Therapy Treatments for Inherited Retinal Diseases
    2019-02-02
    TRVNFDA will agree on labeling to a maximum daily dose of 27 mg for oliceridine for the treatment of pain relief. CRLed when ACRX approved. up 87% week.
    2019-02-02
    VYGRVoyager AAV gene therapy deal with $NBIX $115m upfront and $50 equity. Parkinson's in Ph2
    2019-02-02
    EYEN

    Eyenovia (2018 IPO) nanocap  met the primary endpoint in its Phase 3 MIST-1 trial of MicroStat for the treatment of mydriasis (dilation of the pupil). Microdrop technology for precise eye drug delivery. #insiders buy small quantity since IPO

    2019-02-02
    FBIOFortress Biotech incubator's Caelum Biosci got $60m from $ALXN for CAEL-101 anti-Amyloid antibody for light chain (AL) amyloidosis, previously Prothena NEOD001 failed in a similar hypothesis.
    2019-02-02
    CTICFlt3 JAK2 dual inhibitor Pacritinib myelofibrosis EMA withdrawn
    2019-02-02
    ALKSFDA CRLed ALKS-5461 after refuse-to-file, 2-21 AdCom, and horrible trial design, changes and poor efficacy.
    2019-02-02
    EOLSFDA approved Jeuveau (Botox) for glabellar lines up 31% AH
    2019-02-02
    Biotech6B cost per approval. Cannot recoup investment. Unsustainable model? Why exist, missing something?
    2019-02-01
    ADROAduro to refocus on STING and anti-APRIL. Shelf LADD, CTLA4, SIRPa programs after GVAX, Listeria, and STING setbacks. Below cash.
    2019-02-01
    ACRXto present in the first meeting upon launch, 41st Annual Boswick Burn & Wound Symposium (Feb 2-7, Hawaii)
    2019-01-31
    AMGNbiosimilars eat into Neulasta revenue, generic Sensipar coming; Repatha and Aimovig launch well; look at deals of all size
    2019-01-30
    Biotech

    Big Pharma (represented by PhRMA) Should Accept Cap On Drug Price Increases by inflation rate. HHS may stand down proposal to link to international price. Uncertainty to the industry may be cleared soon.

    2019-01-28
    ADXSFDA partial hold Ph3 axalimogene filolisbac (AXAL) of cervical cancer (AIM2CERV). additional information on AXAL CMC matters.
    2019-01-27
    ABBVHumira international sales -14.8% due to biosimilars
    2019-01-27
    BMYsBLA for Opdivo combined with Yervoy for frontline NSCLC cases with high tumor mutational burden — or TMB withdrawn. new data reading needed
    2019-01-27
    EDITCEO Katrine Bosley resigned abruptly prior to initiation of key trial
    2019-01-27
    ABUS

     Margrit Schwarz of Roche is coming to Genevant;  Jackie Fouse left Dermavant; CFO set. up 12.8% on big volume.

    2019-01-25
    DVAXNat. Immunol. paper on CpG-TLR9 overcomes CD47 block
    2019-01-23
    EXEL
    Cabometyx (cabozantinib) sNDA approved for HCC. tyrosine kinase inhibitor.
    First approval in thyroid cancer in 2012, invested heavily in other cancer, failed prostate in 2014, laid 70% off, share price drop below $2. Won approval in Melanoma 2015, licensed to Ipsen in 2016, approval in 2016.04 for 2nd line Kidney cancer, 2017.12 for 1st line.
    Kinase inhibitor leader. Indication expansion. 20x in 3 years. 7x in 21 months.
    2019-01-19
    TYMESM-88, a modified tyrosine analog to be uptaken by cancer cells and mess up stop their protein synthesis.
    2019-01-19
    AIMTFDA will not commence review of its BLA for AR101, for peanut allergy until the shutdown has ended.2019-01-19
    VRNARPL554 dual inhibitor of PDE3 and PDE4 and stimulating the CFTR, fails COPD.
    2019-01-19
    LXRXLexicon's SGLT2 SGLT1 dual inhibitor Sotagliflozin receives 8-8 split AdCom vote due to increase in the risk of diabetic ketoacidosis (DKA). SGLT2 inhibitors are blockbusters. But SGLT1 also absorbs glucose. company MOADiabetesInControl.
    2019-01-19
    IMMUDavid M. Goldenberg Immunomedics received CMC CRL. Rose from 2 -> 26. Now retrace back to $13. See 2017 drama
    2019-01-19
    LLYLilly’s approved cancer drug Lartruvo (Olaratumab, anti-PDGFR)  fails confirmatory study in Soft Tissue Sarcoma, to withdrawal. $OPHT Fovista (pegpleranib, PDGF-B inhibitor) failed wet AMD.
    2019-01-19
    Alzheonwithdraw 2nd IPO attempt. 3mil cash left. 1st try $80mil. 2nd try $30m
    2019-01-17
    Citronattacks $LGND for unfocused overstated pipeline and partnership. Attacked $ABBV (Humira) $ESRX $MKD (Acthar) to suffer from drug pricing pressure
    2019-01-17
    AMGNRomosozumab 18-1 AdCom 1 against is patient wanting CV risk sorted out
    2019-01-17
    APTX

    NMDA modulator NYX-2925 fails in PhII neuropathic pain study

    2019-01-16
    DVAXHeplisav-B available to Military;  bullish SA article, negative comments
    2019-01-15
    JPMJPM golden pill with golden DNA inside was stupid. Atlas venture partner Booth says farewell. Public company CEO defends its value. I agree with Booth.
    2019-01-15
    MRKPD-1 reduce death risk 31% in esophageal and esophagogastric junction carcinoma subgroup: 222 out of 628 squamous cell carcinoma or adenocarcinoma, who had progressed after standard therapy and whose tumors expressed PD-L1. But not in overall or another subgroup: 401 patients with squamous cell carcinoma
    2019-01-15
    AMGNRomosozumab CV risk OK at FDA briefing
    2019-01-14
    PancreaticJim Allison paper about VISTA and stromal cells in pancreatic cancer
    2019-01-14
    LJPCGiapreza angiotensin II for IV sales fall short again expect FY2019 $24-28mil
    2019-01-12
    INSMArikayce approved 09.28.2018 first quarter 4Q18 $9.7 mil sales. liposome for lung delivery to avoid charged enviroment in lung infection
    2019-01-12
    DVAXOX40 paper: eradicates tumor unlike PD1 only delays; TLR7/8 not as great; Costco vs Sam's
    2019-01-12
    DVAX

    Heplisav sales (mil):
    2018: 0.2, 1.2, 1.5, 3.9
    2019: 5.6, 8.3

    2019-01-12
    SAGEPhase 3 success of SAGE-217 in women with postpartum depression (PPD); Ph2 success in YE2017; waiting for MDD
    2019-01-12
    AXSMAXS-05 for major depressive disorder (MDD) Ph2 success. "right" mix of dextromethorphan and bupropion, but individuals are claiming some success by using their random mix of dextromethorphan and bupropion. Maybe a commercial problem. +180%
    2019-01-12
    MGENCobomarsen miR155 inhibitor show some activity in TALL. but 20% sell off on this news
    2019-01-12
    NeoleukinIL-2 computationally designed for IL2 b g receptor but not CD25 to reduce tox. $THOR
    2019-01-11
    AGRX

    meeting minutes on wear study: ~80 healthy BMI<35 women crossover design 1wk Xulane 1wk Twirla vice versa

    assume: raise $25M (50M shares at $0.5 currently discounted price), $500M peak sales 4X PS, target price will be 2000/85 = $24/share
    2019-01-10
    DVAX

    JPM19 slides, transcripts: Good:

    * Solid Q4 vaccine sales 3.7mil +147%

    * new Pertussis vaccine using 1018 in the pipeline

    * EU EMA MAA 1H19

     

    Not so good:

    * the company now put "on our own" before "partnership": own PD1RR, HNSCC, I-SPY2, other HPV cancers, mostly 1Hor 2H19; PD1 naive ($150m, 700pts) multiple partner discussions

    * SD-101 decision postponed to 1H19 after postponed to early 2019 from End of Year 2018

     

    It seems DVAX has a hard time to get a partnership despite 70% ORR. I wish it is just good things take longer to develop.
    $IDRA also expanding and talking to partner

    2019-01-10
    AMGN$NVS NICE rejects migraine drug Aimovig, months after declining to endorse pricey Kymriah for adult use
    2019-01-10
    CygnalDeveloping exoneural treatments for cancer, immunological, and regenerative diseases, a Flagship venture, Roche exec Pearl Huang as CEO
    2019-01-10
    NKTRsurge above 50MA after JPM showing $1.85B cash and extensive trials and collaborations ongoing and planned
    2019-01-08
    DVAXSam's club deal represents chain pharmacy
    2019-01-08
    ABUS$ALNY Onpattro (patisiran) 4Q sales $11-12M early launch, up 8%
    2019-01-07
    LOXO$LLY $8B buyout TRK fusion drug VITRAKVI and other RET TRK mutation pipeline
    2019-01-07
    GNMXAEVI-001 (oral non-stimulant pan selective activator/modulator of mGluRs.) miss on ADHD. 5mil cash left. Penny stock.
    2019-01-06
    SESNVicinium ADC anti-EpCAM+Pseudomonas Exotoxin A + PDL1 for high-grade non-muscle invasive bladder cancer (NMIBC). positive results but sell on news. Penny stock.
    2019-01-06
    VRCAVP-102 [0.7% (w/v) Cantharidin] for molluscum contagiosum or common warts. Website boasting "innovation in its DNA". Not really an innovation.
    2019-01-06
    EPZMEZH2 inhibitor tazemetostat seek accelerated approval for relapsed/refractory follicular lymphoma (FL). NDA 4Q19
    2019-01-06
    GILDASK1 (selonsertib), TGFb for NASH
    2019-01-06
    PoseidaIPO, CAR-T primarily of long-living early memory T cells, or TSCM cells
    2019-01-06
    UroGenLiz Barrett (Novartis Oncology) Arie Belldegrun MD FACS - Chairman UGN-101 is (formerly known as MITOGEL™) (mitomycin) urothelial gel, 0.4%
    2019-01-04
    Immunocoreget Bahija Jallal president of the big MedImmune
    2019-01-04
    AAPLBuffett average price so far ~$146-149 underwater
    2019-01-03
    NeuBasePeptide nucleic acid (PNA) platform, better than $IONS
    2019-01-03
    BMY$CELG $74B merger $50cash+1share $BMY for 1 share $CELG. Bad for $BGNE?
    2019-01-03
    ABUSABUS IPR challenge Heyes, Thompson, Janoff (Alnylam) depositions, 3-rounds long process up to July 2019
    2019-01-01
    TCRR

    mesothelin-positive solid tumors, HLA-independent TCR tech, TCR2 Therapeutics TCR2

    2019-01-01
    DVAXcGAS-STING is highly expressed in cancer tissues, negatively correlates negatively correlated with the infiltration of immune cells and prognosis
    2018-12-31
    DVAX

    read IDO1 data ORR 56~63%, PFS 12m vs N/P ~6m. SD-101 PFS >15.2m. CrownBio blog on IDO1 and I/O

    Ph3 PFS 4.7m vs 4.9m, numerically poorer, 12m OS same 74%, ORR 34.2% vs 31.5%

    2018-12-28
    DVAX

    new Sanofi vaccine Vaxelis combines 6 diseases; but require 3 doses. a combo of old stuff. Not primary for Hep B

    $ONCS sponsored research on Immunity show PD-1 requires DC/IL-12 to work

    $NKTR 214 deal came three month later with complete terms
    2018-12-27
    EGLTdelisted in September. Once a hot stock
    2018-12-26
    CAPRLA-based Capricor to test CEO Linda Marbán’s husband, Eduardo Marbán, developed at Johns Hopkins. stem cell operators, repeated setbacks.2018-12-26
    ADMAfocus on immunodeficiency. Bivigam 10% Ig. relaunch got CRL. Was shutdown for CMC deficiency. -46%
    2018-12-22
    SPPIpoziotinib inhibits EGFR, HER2/neu, and Her 4 covalently, denied Breakthrough Therapy Designation (BTD) -39%
    2018-12-22
    DBVTViaSkin Peanut patch BLA withdrawn due to CMC and QC data insufficient. Now Aimmune $AIMT will be standard of care (patient will advocate nothing available) and $DBVT will lose this 1st mover advantage
    2018-12-22
    GTHXTrilaciclib a first-in-class short-acting CDK4/6 inhibitor, failed 2/3 line SCLC, 13% ORR vs 23% placebo
    2018-12-22
    HSGXTerminate NeoCart after FDA demanding additional trial down to $0.08 AH 2014 $11 IPO
    2018-12-22
    SPHSTopsalysin, PSA-activated perforin, additional dose has no clincal benefit, 2013 IPO $5, now $0.85. But 1st dose has decent reponse. Designing Ph3
    2018-12-22
    SURFCD47 SRF231 have low dose hematologic dose-limiting toxicities (DLTs) , no Ph1 expansion
    2018-12-22
    AGENest. 1994 $18, reverse split 1:6 2011, antibody platform, HSP cancer vaccine, AI discovery. Running 20 programs and 20+ trials, short on cash, deal with Gilead. Nice website.
    2018-12-22
    ADRO$LLY deal $12M upfront ($620M) for cGAS-STING autoimmune and other inflammatory diseases
    2018-12-22
    FGENFibrogen roxadustat approved in China for anemia in chronic kidney disease (CKD). expertise include: collagen HIF-PHI prolyl 4-hydroxylase enzymes, recombinant collagen synthesis, and extracellular matrix-associated processes and pathologies
    2018-12-22
    ACRSAclaris ESKATA (40% H2O2 Hydrogen Peroxide Pen) for age spots, seborrheic keratoses (SKs)
    2018-12-22
    DVAX

    I-SPY 2 trial, took 1y to graduate for Keytruda, past agents, ASCO17; news about graduates, endpts, design 1, 2, 3

    2018-12-20
    BigPicafter fixing barchart and regression, gapindex have signaled trouble in early October 2018, churning throughout 2018 was also a warning sign, 2015 bear two legs for gapindex
    2018-12-19
    CHMAafter making a stellar +300% rise from $1.2 -> $4.87, now back to consolidation the last bottom? Data expected 3Q2019
    2018-12-19
    ITCI

    lumateperone Ph3 for Agitation in Alzheimer discontinued. Main indication is Schizophrenia

    2018-12-18
    ACRXadded to Nasdaq Biotech Index ($IBB) effective 12/24
    2018-12-18
    ABUS$ARWR ARC-520 was using its DPC EX1 dynamic polyconjugate delivery vehicle via IV infusion, not GalNac subQ
    2018-12-15
    CORT

    up 32% on patent "Differential diagnosis of ectopic cushing's syndrome"; Korlym, orphan drug approved 2012 for Cushing's. Also trying to venture GR antagonists into IO combo

    2018-12-15
    AXON

    licensed 2 more assets from UMass GM1 and GM2 gangliosidosis – also known as Tay-Sachs and Sandhoff diseases

    2018-12-15
    ADXS

    Amgen $AMGN return rights of axalimogene filolisbac attenuated Listeria back to company after 2y and $78M

    2018-12-15
    SGYP

    could not renegotiate debt, file bankruptcy. Management failure on costly launch and debt financing. See link to Bloomberg

    Was a PSIC candidate proposed by Zhou Bo for project 10 in Aug 2015. along with $GWPH $NBIX
    2018-12-15
    NBIX

    valbenazine (Ingrezza, vesicular monoamine transporter 2 (VMAT2) inhibitor) fails Ph2b Tourette syndrome, approved for Tardive dyskinesia, another neurological disorder with involuntary movements

    2018-12-15
    IDRATilsotolimod + anti-CTLA4 data update 32.4% ORR in PD-1 experienced patients. - 40%; dropped -86% more than $DVAX
    2018-12-14
    BigPic

    index makes new low, biotech holds OK? fear of breaking downwards. Sector bullish percent indices at multi year low. Buffett's AAPL price $109

    12-18-2018 $BPSPX $BPCOMPQ need to touch below 25; $RUT approaching 200wk MA.

    12-19-2018 $RUT $TRAN touch 200wk MA; $BPSPX <25 $BPFINA <10 $BPHEAL <15 $BPINFO <20 $DVAX $ABUS holding strong while $XBI -4% to 200wk MA

    12-20-2018 $BPSPX < 20 $BPCOMPQ <25 $BPFINA <8 $BPHEAL <10 $BPINFO <15 $VIX touch 30; big panic on option expiration day 12-21-2019. $CPC 1.82 all time high (previous 1.70: 2.26.2007, 1.69: 8.17.2015) MACD 20,200,12 sharp rise to 0.15

    12-21-2018 $VIX >30 $WLSH approaching weekly 200MA $CPC MACD 0.172 current shiller PE is about 22~24 after forgetting 2008~2010 low earnings. If SPX normalized Shiller PE 16, it will be SPX1760. XBI, IBB. CNCR weekly RSI <30 first time in years, $CNCR lost almost 50%, IBB:XBI weekly spike

    12-24-2018 $VIX >35 $WLSH below weekly 200MA, $CPC MACD 0.183 $BPCOMPQ <20, $BPSPX $BPINDU <15 $BPFINA $BPINDY $BPENER <5 $BPINFO $BPHEAL $BPDISC $BPMATE <10

    12-26-2018 $DJI +1000, 5%, the biggest gain ever. Wait for second legs.

    1-1-2019 CNBC positive outlook for 2019

    1-4-2019 follow-through day FTD 周一中美谈崩 2nd leg down (1-30-2019: did not happen)

    2018-12-14
    Checkmate

    New CEO Barry Labinger from Biothera, Art Krieg now CSO. Biothera uses Imprime CGG (soluble 1,3/1,6 beta glucan from yeast) to combine anti-PD-1

    2018-12-13
    AGTC

    Applied Genetic Technologies Corp fails Ph1/Ph2 rAAV2tYF-CB-hRS1 for X-linked retinoschisis with mutated RS1; $BIIB drops

    2018-12-13
    ACRXcontinuous insider buying by multiple executives post-approval
    2018-12-13
    AGRX

    Meets With FDA on Comparative Wear Study of Twirla® and Xulane: in healthy women with a Body Mass Index (BMI) less than 35 kg/m2 who will be randomized to either Twirla or Xulane for the first week and then switched to the patch not initially worn for the second week.

    Expect to finish study by 1Q19, resubmit 1H19, approval YE19

    2018-12-13
    CAR-Tcytokine storm can be inhibited through Adrenaline pathway. $GILD $CELG $NVS $KITE $JUNO
    2018-12-13
    ACRXSTATNews hit article released on investors' day. Pretty biased. Good investment. 越是唱衰越要买. Comments are sharp. Zalviso sales flat.
    2018-12-11
    AXON

    nelotanserin failed again on Lewy body dementia

    2018-12-10
    SNNA

    LA company. SNA-120 (TrkA inhibitor with polymer) fails mild-to-moderate psoriasis

    2018-12-09
    SUPN

    SPN-812 Viloxazine hydrochloride for ADHD, met endpts, size too small to compete. a morpholine derivative and is a selective norepinephrine reuptake inhibitor used as an antidepressant in some European countries,

    2018-12-09
    CNAT

    another Ph2b failure ENCORE-PH trial for the treatment of NASH cirrhosis. Emericasan pan-caspase inhibitor and has antiapoptotic and antiinflammatory effects

    2018-12-09
    VNDA

    tradipitant (NK-1R antagonist) Ph2 success in gastroparesis

    2018-12-09
    BHVN

    rimegepant (Zydis orally dissolving tablet (ODT) formulation) Ph3 success. CGRP receptor antagonist

    2018-12-09
    GBT

    up 48% to $46.62 FDA will allow an accelerated approval pathway for voxelotor for sickle cell disease (SCD)

    2018-12-09
    MRNA$600mil $23 midrange 20% more shares 7.5B cap largest biotech IPO in history
    2018-12-06
    ABUSBrii Bio (Zhi Hong, ex-GSK) partnership with VBI, Vir (Alnylam RNAi) and Wuxi (bispecific Ab) for HBV cure
    2018-12-06
    BigPicHuawei Wanzhou Meng arrested by Canada, market sell off after the interest rate inversion panic; but all my stock and XBI reversed and enter green mid-day, SPY reversed as well. Endpts: NYCEDC build space for life science
    2018-12-06
    ABBVROVA-T may associate with lower survival
    2018-12-05
    Grailpoor HKEX IPO performance and volatility urged Grail to go for US only IPO, as well as Moderna $MRNA
    2018-12-05
    ALLO

    off-the-shelf CART UCART19 needs prevent rejection by lymphodepletion plus immunosuppress 14/17 CR

    2018-12-05
    ASH

    $GILD Yescarta great survival but only $183mil revenue 9 month
    $REGN REGN1979 anti-CD19 x anti-CD3 bispecific antibody 80%CR and 100%ORR in heavily treated relapsed and refractory follicular lymphoma
    BiTE bispecific vs CART: Endpts.com

    2018-12-03
    TSRO$GSK bought at $75/share 5.1B 60% premium, compare to all time high $190, recent low of $23.41, PARP inhibitor Zejula and PD-1, TIM-3, LAG-3
    2018-12-03
    BGNE

    best in class PD-1 antibody tislelizumab doubled CR rates (30% -> 60%) in treatment-resistant classical Hodgkin’s lymphoma. Western patients were typically pre-treated with Seattle Genetics’ Adcetris, which isn’t available in China.

    2018-12-03
    Y+300%

    $TNDM insulin pump
    $PRQR ADAR RNA editing QR-110 for LCA
    $AMRN Pure EPA OMEGA-3 reduce CV risk
    $ECYT purchased by $NVS
    $TLRY cannabis
    $VCEL autonomous cell culture transplant for cartilage and skin
    $OASM nanoparticle platform XR17 micelle
    $VKTX similar to $MDGL
    Y+500% only 1 $TNDM

    2018-12-02
    ALKS

    ALKS 3831 Olanzapine/samidorphan (antagonist of the μ-opioid receptor) for the treatment of schizophrenia Ph3 success showing less weight gain compared with olanzapine,

    2018-12-01
    HSGXNeoCart BLA delayed
    2018-12-01
    CPRX

    Amifampridine phosphate, a nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization, to improve LEMS patients whose nerves suffer from autoimmune disease.

    2018-12-01
    ASNS

    see previous notes, recent IPO, antibody to treat bacteria disease failed, now reverse merger after only 1 year IPO

    2018-12-01
    VRTX

    VX-659, tezacaftor and ivacaftor in patients with cystic fibrosis meet Ph3 success. patients with one F508del mutation and one minimal function mutation

    2018-12-01
    ZFGN

    MetAP2 pathway (metabolize fat) for type 2 diabetes on clinical hold for CV risk

    2018-12-01
    CRL Rev

    $AQST PharmFilm Sympazan™ (clobazam) Oral Film approved but Erectile dysfunction CRLed
    $TRVN Oliceridine opioid pain med
    $XOMA Canakinumab anti-IL1b for CV risk (approved drug from $NVS)
    $GSK mepolizumab anti-IL5 for COPD

    2018-11-30
    ABUSPPT: AB-506 data Q2 2019; AB-729 Ph1b start Q2 2019; to combine the two in Q2 2020; RNA destablizer AB-452 or backup postponed to Q2 2020. $ALNY: revenue light upon launch
    2018-11-30
    DVAX$AZN AZD1419 Ph2a asthma fail, speculation was wrong
    2018-11-30
    Endpts.com

    I/O R&D explode +67% in 2018; China #2; Opioid crisis continue with fentanyl; US life expectancy declines

    11.30.2018 CTLA-4 still dominates PD1 combo landscape, chemo etc.
    2018-11-29
    Antios

    $ABUS competitor, newly founded by Pharmasset SVP Abel De La Rosa, PhD and Idenix CMO Douglas Mayers, M.D, raised 25M Series A

    2018-11-28
    LOXO

    VITRAKVI (larotrectinib) won approval for TRK fusion cancer regardless of cancer organ. share price drop on news

    2018-11-27
    DVAX

    head-and-shoulder bottom (post to IV 11.28.2018); $ACRX head-and-shoulder bottom; $ABUS base on base

    2018-11-26
    DVAX

    Opdivo+Yervoy fails NSCLC checkmate-451; VR475 nebulized budesonide fails severe uncontrolled asthma

    2018-11-26
    AIMTPh3 results published on NJEM
    2018-11-21
    BigPicBig drop new low, $VIX third leg, Tech stocks drop big, $XLV $IBB hold well
    2018-11-20
    ABUS

    Genevant promoted CSO Hansen to CEO

    2018-11-19
    THORSynthorx files IPO based on IL-2 lead $NKTR
    2018-11-17
    TSROlooking for sale
    2018-11-17
    INFIIPI-549 PI3K-gamma inhibitor + PD-1: 2 PR out of 44 patients in solid tumor
    2018-11-17
    EIDXAG10 small molecule to stabilize TTR
    2018-11-17
    QUREthree patients average 31% expression FIX after AMT-061  for hemophilia B
    2018-11-17
    ARNA

    licensed Ralinepag APD811 for $800m upfront

    2018-11-17
    DVAX$AZN PD1+CTLA4 $HCM VEGF+PD1 both failed NSCLC. Good more DV281? or $AZN buyout if AZD1419 good?
    2018-11-16
    ABUS$MRNA moderna S-1 no mention of LNP patent dispute
    2018-11-15
    DVAXa patient cured melanoma posted on twitter using SD-101
    2018-11-14
    BigPicpeople talks about shorting $XBI very bearish; moderna IPO signals IPO window closing?
    2018-11-14
    NKTR$DVAX NKTR-214 may have some effect to boost T cell from exhaustion. See my post on IV
    2018-11-12
    TSROTSR-022 TIM3 + TSR-042 minimal effect; all the investors fall in love with their own stock, anything is encouraging :)
    2018-11-10
    SGMO

    AAV-FVIII SB-525 for hemophilia A delayed

    2018-11-10
    NKTRNKTR-214 53% ORR but CR improved to 24% #SITC $DVAX
    2018-11-10
    ADROSTING has no effect as monotherapy #SITC as $MRK shows. $DVAX
    2018-11-10
    ABUSModerna $500 mil IPO $MRNA largest biotech IPO
    2018-11-10
    ACRX12mil shares offering at $3.15 20% dilution
    2018-11-09
    DVAX$ONCS phase IIb only 2 in 9 PR similar to SD-101, down 50% to penny stock, no longer a threat to $DVAX
    2018-11-06
    DVAX$AZN sold older asthma drugs to other firm, reflecting its strong pipeline, including AZD1419
    2018-11-06
    ACRXZalviso revenue declines; people worry about Tmax vs IV morphine. Forgot about blood brain equilibrium
    2018-11-06
    DVAXER CC, 3 more CR after #ESMO as I predicted in June after #ASCO, may not >20% (11.13.2018)
    2018-11-05
    CLSD

    XIPERE (formerly “suprachoroidal CLS-TA”) + Eylea combo no better than Eylea alone in retinal vein occlusion (‘RVO”) to focus on Uveitis, NDA filing by YE2018 down 63% to $2.07

    2018-11-05
    PUMA

    3.5% QoQ growth, Nerlynx sales continue to disappoint

    2018-11-03
    CLVSRubraca PARP inhibitor sales disappoints, re $TSRO
    2018-11-03
    SBBP$AEZS Macrilen sold to Novo Nordisk $145m, paid $24m
    2018-11-03
    ARGX

    ARGX-110 cusatuzumab anti-CD70 for AML MDS 92%(11/12) ORR 75% (9/12) CR

    2018-11-03
    SAGE

    brexanolone (SAGE-547) allosteric modulator of GABAA receptors AdCom 17-1

    2018-11-03
    ALKS

    ALKS-5461 a combination drug formulation of buprenorphine and samidorphan for adjunctive treatment of major depressive disorder (MDD) failed 2 phase III trials but success 1 phase III trial. 2-21 AdCom vote

    2018-11-03
    CHRS

     pegfilgrastim biosimilar candidate CHS-1701 (Udenyca) approved

    2018-11-03
    ACRX

    approved close up 16%. No big jump. 52-week new high. FDA issued Gottlieb PR about opioid and DOD. see link for news. Media bashing FDA and $ACRX without telling the truth. Yahoo boards full of short term speculators. $TRVN CRL ask for more data

    2018-11-02
    AGRXER says cash enough to fund through wear study and into Q2 2019
    2018-11-02
    TRVNrose +30% prior to PDUFA date, many people speculating an approval on StockTwits
    2018-11-01
    DVAXpatents about Heplisav-B licensed agreement reached with GSK and Merck ref1, ref2
    2018-10-29
    Sunlinot many companies have the expertise in process development of biologics like Amgen and Genentech. Even Pfizer or Merck may not match them.
    2018-10-28
    RARE

    UX007 (a highly purified, synthetic seven carbon fatty acid triglyceride) fails in patients with glucose transporter type-1 deficiency syndrome (Glut1 DS) experiencing disabling paroxysmal movement disorders Phase III

    2018-10-27
    SNDX

    Entinostat HDAC inhibitor plus exemestane miss PFS endpts in breast cancer see previous failure notes

    2018-10-27
    SGYPcould not find a buyer even with a product Trulance
    2018-10-27
    CMTA

    Clementia RARg agonist Palovarotene file NDA for FOP bone disease, BMP pathway regulation for rare bone disease

    2018-10-27
    MRTX

    sitravatinib+Opdivo disappoints in NSCLC 16/56 28.6% ORR

    2018-10-27
    ADAPEngineered SPEAR TCR MAGE-A10 MAGE-A4 no response at ESMO
    2018-10-27
    DVAX46-47% PFS for Pembrolizumab; 85% SD-101 combo at ESMO; $MRK $BMY ready for deal derby (see link)
    2018-10-26
    绿谷

    Oligo-mannurarate (marien derived Oligosaccharide) GV-971 meet Phase III endpts. targets Amyloid for clearance

    2018-10-26
    DVAX10.22 ppt highlights: cellular biomarker data compare 2mg vs 8mg TME; phase III decision early 2019, neo-adjuvant I-SPY 2 breast cancer study initiated
    2018-10-25
    NKTR

    $BMY reluctant to move NKTR-214 to Phase III, want randomized phase II trial
    Thomas Lynch "what it comes down to is that when you look at immuno-oncology there are three validated mechanisms. You've got the PD-1 success, you've got CTLA-4 and you've got IL-2. And we think the opportunity to partner with Nektar to develop this agent, it's a pegylated form of IL-2, was a unique opportunity."
    "for earlier IO assets, it is helpful where possible to see randomized data before moving to registrational studies."

    2018-10-25
    BigPic

    market bounce $BPHEAL down to 23.81 lowest in years
    10.26.18 $CPC continue spike; $BPHEAL 20.63 $BPFINA 17.91
    10.29.18 $CPC 20MA 1.11; MACD 0.147
    10.30.18 $CPC 20MA 1.13; MACD 0.150

    2018-10-25
    ACRX

    public advocates Dr. Raeford Brown Jr. and US senator Ed Markey urged FDA to reject Dsuvia

    2018-10-24
    BigPic

    another big down day. IBB -6% XBI -7%. REGN to 200MA. BPI further down $BPFINA <20 $BPHEAL 33.33
    $CPC MACD >0.121 XBI RSI below 30

    2018-10-24
    BigPic-2205 net gap. index spike down, needle downward. $VIX didn't make new high. Sectors Bullish Percent Indices below 30
    2018-10-23
    ADRO$MRK STING agonist 3-3-cGAMP (Invivogen) is indeed a bacteria product. Human cGAS makes 2-3-cGAMP, $ADRO c-di-GMP
    2018-10-23
    AZNcould it buyout $DVAX? had deal with Innate Pharma for anti-NKG2A monalizumab checkpoint inhibitor
    2018-10-23
    ADROJanssen terminated Listeria license and Aduro discontinued that program.
    2018-10-22
    MRKSTING agonist MK-1454 ESMO mediocre results 0% mono 24% combo in indications with little info on PD1 efficacy $ADRO -30%
    2018-10-22
    DCPHDCC-2618 KIT PDGFRa dual inhibitor ORR dropped to 21% from 24% for GIST
    2018-10-22
    ECYTacqurie by Novartis for $24/share and $2.1B
    2018-10-22
    MACKMM-121 (seribantumab, anti-HER3) + docetaxel failed NSCLC futility
    2018-10-22
    REGNdupilumab (anti-IL4R) approved (new indication) for asthma
    2018-10-22
    EYPTextended release platforms for eye drug release
    2018-10-22
    DVAX

    ESMO PD1 naive continue 70% response
    8mg improved from 38% to 48% with only one more patient. 2mg will improve too. Durable response
    67% abstract/poster (9.21 cutoff) to 70% PR (10.20)
    ipi+nivo was 73.5%(wrong, subset) 50% in Phase III, toxicity problem, 11.5m PFS vs at least 15.2m SD-101
    HNSCC (~30%) and PD1 experienced (21.4%) are 8mg, new recruitment will be 2mg
    people questioning 1-arm design and no monotherapy

    2018-10-20
    DVAXHNSCC 30.4% ORR 8mg
    2018-10-19
    DVAX

    DV-281 dose escalation is done, now Nivolumab is selected as anti-PD1 drug - good approach to have BMS drug on board as another potential SD-101 partner besides Merck. Enrollment number is extended from 80 to 167, all 5 trial site locations are published. 4 Cohorts (Squamous, PD-1 naive or not, EGFR/ALK mutation ) are specified.

    2018-10-17
    BigPicMID cap and small caps dropped more than big cap, a big cap rally coming?
    2018-10-16
    MNLO

    Serlopitant, NK1-R antagonist, failed cough after failing AD in April. to focus on pruritus (itching)

    2018-10-13
    AFMDTandAbs novel NK or T cell engager. AFM11 on clinical hold due to SAE in 3 patients of NHL and ALL trial
    2018-10-13
    IMDZCancer neoantigen and vaccine company. NY-ESO-1 based CMB305 failed Tecentriq combo in synovial sarcoma, focus on G100 intratumoral TLR4 agonist for NHL.
    2018-10-13
    miRNA

    Nature Biotech: Setbacks shadow microRNA therapies in the clinic

    2018-10-12
    ALLOAllogene, IPO big2018-10-12
    ABUS

    AB-452 acts as small molecule drug against Stem Loop α (SLα) of HBV mRNA. Poster; reference12. Roche RG7834

    Capsid: AL3778 withdrawn before recruiting, ABI-H0731 Ph2 started mid 2018

    2018-10-12
    CORISwiss billionaire Bertarelli purchase Corium $AGRX
    2018-10-12
    ACRXAdCom 10-3 favorable votes
    2018-10-12
    TRVNTrevena announced "successful" meeting with FDA when FDA didn't agree with it. AdCom negative (7-8). $ACRX
    2018-10-11
    DVAXUCLA Ribas article and 13G show Healthcor 5.5% ownership
    2018-10-11
    AdCominteresting novel companies I follow should have an AdCom, no Adcom no good. $DVAX 2nd CRL, $AGRX 2nd CRL (it was intended after adhesion issue solved for efficacy and safety), $ACRX 2nd CRL (an AdCom was required for all opioids)
    2018-10-10
    ACRXbriefing doc and question released, pre-market down to $1.62 due to false interpretation, open flat and then up, close +36%
    2018-10-10
    DVAXAZD1419 Ph2a completed on 9.25.2018, ESMO PD-1 experienced abstract 1262P not so interesting
    2018-10-10
    TRVN

    $ACRX competitor IV-PCA novel μ Receptor G Protein Pathway Selective (μ-GPS) Modulator, mediocre results in Phase 3, slightly better at safety in lowest dose, slightly better at onset time in higher doses. Down 64% with AdCom briefing doc

    2018-10-09
    ABUS

    Today I finally realized that day-to-day follow-up and analysis of ABUS is pointless. I will go silence on this board, as if it matters :) I am ready to join Vivek as the long term investor (a.k.a bag holder). My average cost is less than $4. Wake me up when Sofia leaves. Pharmasset founded in 1998, IPO 2007.04, acquired 2011.11. Oncore founded 2012, Public in 2015.04

    2018-10-09
    Endpts.com

    $NVS novel MS drug by binding S1p1 to prevent lymphocyte brain migration
    $GSK invest into Sitryx immuno-metabolism
    $ONCE GAA enzyme AAV gene therapy for Pompe disease
    $DVAX neoadjuvant study from MD Anderson toxicity concern

    2018-10-09
    ABUS-33+% ARB-1467 disappointing response, AB-452 RNA destabilizer delayed due to nonclinical safety findings, AB-506 capsid progress, new development chief from Janssen. My cost is lower than Roivant $5.28
    2018-10-09
    AGRXcompleted FDRR nominally denied provided path forward to do a wear study comparing to Xulane, AdCom afterwards
    2018-10-09
    DVAX6 month PFS for Pembrolizumab was 34-38% for Ph2 melanoma; 3 abstracts at ESMO
    2018-10-08
    OMER

    OMS721 MASP2 (mannan-binding lectin-associated serine protease-2) failed in renal disease

    2018-10-06
    IONS

    Tegsedi (inotersen) for ATTR approved

    2018-10-06
    RHHBY

    emicizumab (Hemlibra), a BITE antibody that mimics Factor VIII which lack patients with hemophilia A by bridge F9 F10

    2018-10-06
    DVAX

    Thanks for sharing my post :) And thank fairvalueforyou for reminding the previous post, and most importantly for the inspiration. It is really an original way to look at clinical trial updates.

     

    I shared that article to my college classmates. One of them is a fund manager in China. He was excited but was not sure that is a known or proven way to look at trials. Any previous examples. He was anxious that no analyst or even the company itself talks about AZD1419. It seems it is not important to them.

     All I can say is, look at the logic. Make your own judgement. Being ignored is a blessing in investment. 
    2018-10-05
    ARWR

    deal with $JNJ 175M upfront $75M equity @$23. $ARWR just dumped ARO-HBV to focus on other pipeline. JNJ will have worldwide license to develop and market it. Good luck to JNJ.

    2018-10-04
    DVAXcame down from $24 to $10 to close AdCom gap in July 2017 despite approval, SD-101 early results
    2018-10-04
    NKTR

    PlainView respond to company's response. Peg-IL2 is not going to turn tumor hot.

    2018-10-04
    ABUSextra-hepatic LNP targeting screening method by Scripps
    2018-10-03
    ABUS

    Replicor drive 70% (28/40) patients < 1IU/ml, 60% (24/40) non-detectable. AB-1467 can only do 5/12 <50IU/ml

    2018-10-02
    DVAX

    mRNA vaccination with charge-altering releasable transporters cures established tumors; not LNP $ABUS
    New heplisav-B trial in CLL/SLL sponsored by NHLBI

    2018-10-02
    ACRX

    29% flash crash when XBI down 2% to 200MA.
    - CEO said the FDA appraisal of Dsuvia as reflected in the briefing documents was fair (as he said yesterday.)
    - The company is now concentrating on Zalviso
    - Zalviso has serviced 26k patients in the EU without complications

    2018-10-02
    Nobel

    In a 2013 interview with Nature, Allison described the resistance he met when he first tried to get pharmaceutical companies interested. “It was very frustrating,” he said. “They said, ‘It may work in mice, but it’ll never work in people’. The concept was new and it was so unusual.” Allison marched from company to company in search of one that would take on the project. Ultimately, Bristol-Myers Squibb of New York City was the one to push ipilimumab over the finishing line.

    2018-10-01
    CHMACompleted enrollment early, now expect OPTIMAL results Q3 2019
    2018-10-01
    DVAX

    Cantor talk 24:46 $AZN anticipate AZD1419 high level results by year end 2018. Completed as planned.

    2018-10-01
    Nobel

    goes to James P. Allison and Tasuku Honjo “for their discovery of cancer therapy by inhibition of negative immune regulation.”

    2018-10-01
    NKTR

    Ex-Kerrisdale analyst Aaron Wedlund short attack on NKTR-214: ‘It doesn’t work’. 2% peak conc. <1% activity

    2018-10-01
    AGRX

    Dr. Woodcock is acting director of OND and director of CDER; OMPT is vacant. If no favored opinion from Woodcock in the coming weeks, it may take many months and Dr. Gottlieb to get a final call on Twirla

    2018-09-29
    ANAB

    etokimab (anti-IL33) show 8-11% FEV1 lung function improvement over placebo

    2018-09-29
    ALDX

    topical ocular reproxalap for dry eye disease. RASP inhibitor to reduce aldehyde and inflammation. Hsp90 inhibitor

    2018-09-29
    TGTX

    ublituximab (anti-CD20) plus umbralisib (PI3Kd inhibitor) combo for CLL could not be analyzed for ORR, to focus on PFS

    2018-09-29
    GERN

    Imetelstat: first-in-class telomerase inhibitor. Rights returned by $JNJ surprised from expectation

    2018-09-29
    AMRN

    Vascepa (icosapent ethyl) pure EPA Omega-3 derivative for Cardiovascular. was approved in 2012 for limited indication, now reported positive for broader indication up 444%

    2018-09-29
    Biotech

    The Incredible Expanding Universe of Biotech Stocks: IPO outpaced market, more public companies, higher valuation

    2018-09-28
    DVAXactual enrollment larger than assignment, then split between arms?
    2018-09-27
    DVAXat least two abstract at ESMO, melanoma and HNSCC
    2018-09-26
    GTXI

    Selective Androgen Receptor Modulator (SARM) enobosarm in post-menopausal women with stress urinary incontinence (SUI) failed Ph2, down 92%

    2018-09-25
    VKTX

    up 87% success on Ph2 NAFLD $MDGL competitor same MOA,

    2018-09-25
    MTEM

    Engineered Toxin Bodies (ETBs) platform Forced Internalization, enzymatic and permanent ribosome inactivation, De-Immunized Toxin Scaffold, Payload Delivery? RNAi? deal with Takeda for CD38-ETB

    2018-09-25
    ACAD

    FDA safety inspection came positive: no new or unexpected safety findings

    2018-09-25
    AGRXadd 3000 shares ($1k)@$0.3413 (3000*$0.33+penny stock fees), island reversal; Great decision (2018.10.12)
    2018-09-25
    ABUSIPR instituted Patent Inter Partes Review
    2018-09-15
    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! $2.5 12.2018
    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 approved 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. $5.28 per share equivalent
    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