DVAXTLR7 viral IFN induction is impaired in Asthma. TLR9 same fate? IFN reverse Th2 in human

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


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


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

SNDXEntinostat HDAC inhibitor poor results post hoc in monocytes high patients
AGRXType A meeting minutes requested reformulation, bioequivalence, new phIII trial. Decide to appeal. 80% accept 16% granted
NVOstem cell therapy to cure diabetes

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


$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

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

funding from Ge Li for  CPMPs — cell penetrating miniproteins. a structural “brace” that promises to make their polypeptides effective against tough targets like β-catenin.


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

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

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


$AMGN $NVS Lilly's galcanezumab fell behind erenumab


murepavadin against Pseudomonas aeruginosa and anti-CXCR4 drug balixafortide oncology

XenikosT-Guard targeting CD3 and CD7 for GVHD

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


PI3K inhibitor for a common non-Hodgkin lymphoma

LLYbought back Aurora kinase A inhibitor it shed in 2016

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


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

SURFCD47 overexpress on tumor cells to prevent macrophage phagocytosis

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

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. $16 level resistence. Fearing ER sell off was controlled.
REGN$GILD $CELG $BIIB $INCY all experience deep correction to low P/E. Bottom and trend reversal may come in 2019
IONS$AKCA won AdCom 12-8 despite safety concern
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

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

BiotechTrump speak on drug pricing, lots of promise, no tough measure. Endpts.com opinion on high healthcare cost

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


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


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


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


new microbiome IPO "monoclonal microbials"


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

LodoMetagenomics from soil bacteria for drug discovery

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

ABUSAdd 655 shares ($4k)@$6.10 Abandon LABU (time decay is annoying)
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).
ABUSAdd 421 shares ($2.6k)@$6.15 upon breakout cup-with-handle pattern

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


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

Ascletisfirst HKEX pre-revenue IPO. ex-GSK Wu JInzi. HCV leads

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


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


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


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


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


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


Genentech R&D leader Dietmar Berger moves to Atara Bio, heading up off-the-shelf allogeneic EBV associated T cell work. Michel Sadelain of Memorial Sloan Kettering

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

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


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


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


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

AKAOAdCom split on two indications for this new antibiotic

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

CasmaAutophagy for neuro disease
ABUSModerna challenging ABUS '127 '435 patent, claim same old patent repackaging

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

ABUSModerna/Merck targeting KRAS with mRNA but denies ABUS' IP
JNJJanssen bought oncolytic virus company BeneVir

bempedoic acid lukewarm efficacy, safety concern, low price position

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

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


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


oral neuronal nicotinic receptor (NNR) assets for cough

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

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

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

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


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


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


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

CELGCelgene refuse-to-file was due to newly identified active metabolite. still rise 3%
ACADtanks after CNN reports FDA safety investigation

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

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

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

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

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


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


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


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

Cedillaprotein degradation using small molecules, focusing on oncology

baricitinib (JAK1/2 inhibitor) adcom 2mg 10-5 4mg 5-10 needs more safety data on thrombosis. Rejected 2017. allowed Lilly to refile as second-line therapy without the added data. Pfizer’s Xeljanz (tofacitinib) already marketed no safety concern.


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

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

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


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


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


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

ARGSArgos individualized DC immunotherapy. PhIII discontinue. Delist from NASDAQ
GWPHAdcom positive

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


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


FDA director of CDER Division of Pulmonary, Allergy and Rheumatology Products Badrul Chowdhury to head Respiratory, Inflammation, and Autoimmunity, Innovative Medicine and Early Development Biomed Unit.

FCSCFibrocell fibroblast cell gene therapy waving white flag and looking for reverse merger

publication in Anesthesiology - the best journal in the field

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

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

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

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


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

DVAX$MRK NSCLC chemo combo data impress 12m OS 69.2% vs 49.4% Ctrl. Median PFS 8.8m vs 4.9m. I/O combo down $NKTR. Updated data; 33% 6/18 ORR in HNSCC. 86% response ongoing in MEL-01 after 18m. Sell on news.

HF study complete. Reaffirm 2Q resubmission. Break above $2.35 (6 month high). HF是没啥悬念的 那个24 hr max也没悬念 只不过在CRL之前很难预见会有这样的问题 股价当时涨的太猛是个问题,但也是事后看。事前很难说有胆识在$5.5退出。


David Hung wipes Axovant from his work history

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

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


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

ILMNFDA releases NGS and oncology diagnostic guidelines

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


Enterprise Therapeutics target the ion channels TMEM16A and ENaC. improving hydration,  clear away mucus in COPD and asthma. not genetically calibrated but broad patient populations

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

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.

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

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.

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

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


MGTA-456, first-in-class allogeneic stem cell therapy consisting of a single umbilical cord blood unit expanded with an aryl hydrocarbon receptor (AHR) antagonist then administered to a patient through BMT

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

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


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


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


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


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


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


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


$MRK $DVAX $NLNK IDO1/PD1 Keytruda/epacadostat combo failed hazard ratio 1.00, reverse PhII results. Art: combining two checkpoint inh., but not activating immune system. STING, TLR7/8, RIG-I not validated in human. AdamF: first real test of I/O combo. Loncar: @WilliamBlair MRK didn't have epaca/keytruda in a lung cancer pipeline slide "just a clerical oversight"


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


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


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

TernsWeidong Zhong 钟卫东 as CEO, also CSO 苏州银杏树(HCV),杭州先为达顾问(NASH, NAFLD)

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


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


The control eyes did as well with their eyesight as the treated. a bilateral treatment effect. SD-OCT demonstrated statistically significant preservation of both retinal ganglion cells and retinal fiber layer. down -34% mystery shy.

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

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


dacomitinib EGFR inhibitor for NSCLC. Priority review


Kite vets Arie Belldegrun and research chief David Chang launched with $300 million and a collaboration with Cellectis after bagging full portfolio off-the-shelf CAR-T drugs in development at Pfizer. South San Francisco


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

AZNanti-CD22 for 3rd line hairy cell leukemia

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


MN-001, (tipelukast) small molecule anti-fibrotic and anti-inflammatory, leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and 5-lipoxygenase (5-LO). small Phase IIa NASH study, reducing triglycerides

Macrolidesame scientific founder Andrew Myers as failed Tetraphase $TTPH

CDK 4/6, IL-17, IL-23, PCSK9, CGRP,” Skovronsky, the former CEO of Avid Radiopharmaceuticals. “Our scientists were among the first working on these targets. we were slow getting up the courage to move into human trials.


FDA would not review the Alkermes drug, ALKS-5461, because of “insufficient evidence of overall effectiveness,” additional “well-controlled clinical trials” needed. three phIII trials of ALKS-5461 in treatment-resistant depression. Two failed to hit their primary endpoints. Alkermes argued the “totality” of the depression data showed ALKS-5461 to be effective. #refuse-to-file

sequential parallel comparison design SPCD. the first round of placebo patients who don’t respond to the drug are re-randomized between the drug arm and the sugar pill, in order to quell the high placebo responses that have scuttled numerous other trials for depression. If this drug failed to get past Janet Woodcock as well as FDA commissioner Scott Gottlieb, after the FDA reversed three other rejections early in Gottlieb’s tenure at the agency, it’s unlikely circumstances will change now.


Outstanding Shares: At March 6, 2018, 55.1 mil common shares. 5.4 mil options and 1.2 mil convertible shrs, which will be mandatorily convertible into 22.6 mil shares on October 18, 2021. total 83.1 million


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


NKTR-262 (TLR7/8) started (2.16.2018) a Phase1/2 trial recruiting 393 patients in 8 different cancers, but only 2 locations.

$NKTR rose 10 fold in a year.  $DVAX
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

CLDXOur collaborator at CellDex progress Flt3L CDX301 into PhII cancer trials
ZSANZosano 1:20 reverse split to 2mil shares and $10m Mcap. Then raise $50m for 10mil shares at $5. Was $26 3 weeks ago.

Precisa is Edge’s programmable, biodegradable polymer-based platform. an external ventricular drain (EVD) vs oral nimodipine in adults who suffer an aneurysmal subarachnoid hemorrhage (aSAH) resulting from a ruptured brain aneurysm. #PhIII failure


an inhaled, dual inhibitor of PDE3 and PDE4 and stimulating the CFTR, "RPL554 has the potential to be a more effective and better tolerated treatment of COPD than existing standalone PDE4 inhibitors. ... other respiratory diseases, including CF.

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)

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

04.02.2018 further panic drop


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

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

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


appointment of John Saia as General Counsel. from McKesson Corporation, where he most recently served as its Corporate Secretary and Associate General Counsel.  included leading and supporting nearly 100 acquisitions. Prior to McKesson, was a senior attorney at DLA Piper, advising clients on capital markets transactions, public reporting and M&A.  Earlier in his career, was an attorney and special counsel at the U.S. Securities and Exchange Commission (SEC).

DVAXWHO call for better HBV treatment $ABUS
ABUS$ARWR begins dosing. Ego@IV discuss how rushed they are and how they sell their stocks

Biohaven’s oral rimegepant (BHV-3000) show non-competitive results. pain freedom rate was 19.2% and 19.6% for the drug, versus 14.2% and 12% for the placebo arm. Freedom from MBS was 37.6% and 36.6% versus 25.2% and 27.7% in the sugar pill group.


Enfortumab vedotin (ASG-22ME) is an antibody-drug conjugate (ADC) composed of an anti-Nectin-4 monoclonal antibody attached to our synthetic cell-killing agent, monomethyl auristatin E (MMAE). FDA Brealthrough


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


peptide ulcerative colitis drug PTG-100. High placebo response


CD47, CD73, tumor microenvironment, Surface Oncology


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


Ralinepag (APD811), is an oral IP receptor agonist targeting the prostacyclin pathway for pulmonary arterial hypertension (PAH).

Etrasimod (APD334), is an oral S1P receptor modulator, targeting S1P receptor subtypes 1,4 and 5 in autoimmune diseases such as ulcerative colitis.

ACRXAdd 960 shares ($2k)@$2.05

Yesterday may be to shake off the weak hands before the big news. Nothing unknown told by the Wedbush analyst. Volume swelled a little, but not too much. Panic / uneasy on the IV board. 3.23.2018 Further up in bigger voulme, despite a big down day for Biotech.


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

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.
ModernaHK and NASDAQ dual IPO as early as 2019. Also Grail

Falling behind giant migraine drug rivals, Alder ousts founder Randy Schatzman, recruited a CEO with prior sale experience — could a buyout be next? $AMGN $NVS Aimovig (erenumab) under review presented nice PhIIIb results in 2018.01. Aimovig unique anti-CGRP Receptor MOA.


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

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

High profile investor Sahm Adrangi’s Kerrisdale launched a short attack on PTI "breakthrough designation" and PhII data. "... tiny placebo arm (4 patients) had a sharp, sudden and unexpected drop in lung performance during the 28-day trial that created a gap favoring the drug." Came horus after PTI plan to raise capital. Also attacked Allied Minds (LON:ALM) and Prothena (PRTA). cancelled offering the next day due to “market conditions”


FDA approved its diet pill Belviq (Lorcaserin, activates 5-HT2C receptor) in 2012.06.27 But share price declined ever since -99%. Reverse split. Layoff. Sold rights. Many other prescription diet pills all fail. #commercial

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

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

NOVNNOVN asked for a pre-NDA meeting, FDA advised another pivotal trial (a guidance meeting). Seeking third party funding to develop ance indication.

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

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.
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.

3rd PhIII failure. Keyzilen(AM-101) blocks cochlear NMDA receptors to suppress the aberrant excitation of the auditory nerve that is perceived as tinnitus. 1:10 reverse split.


Orexigen, plummet 96% from height in 2015. Despite a best-selling weight loss drug, has faced hurdle after hurdle, including a legal fight to defend patent rights (won against Actavis) and a lackluster market for diet pills in general. Failed to reach $100 million in sales by the end of 2017, triggered a payment it could not afford. #Commercial #Debt


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


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


Lundbeck bags a PhII Parkinson’s drug with $1.1B buyout deal. mGluR4 as an alternative to using dopamine to control the motor symptoms of Parkinson’s. François Conquet founded Addex back in 2002 and ran it for three years, leaving it with an mGluR5 program.

Arbor Biotech.New and smaller Cas13d. Co-founded by Feng Zhang. Also touts AI, computational systems pharmacology for efficient drug discovery. Same enzyme reported by Salk research in the same issue of Molecular Cell, can also edit RNA. #EDIT #CRISPR
DVAXAACR abstracts out embargoed. Both Dr. Cohen and Dr. Ribas to give poster presentations.
ABUSQ4 report. No deal yet with Roivant. Candidates progressing. IV post shows me their long past history of disputes over LNP. Sue. Merge.

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

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

up 50% on cystic fibrosis breakthrough status


oral anti-TNF for ulcerative colitis. hTNFRII-IgG1Fc fusion. PhII 24 patients (18 completed, 67% response, 28% remission). avoid immunogenicity, malignancies and opportunistic infections

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

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


glycobiology, galectin inhibitors, announced AML OS as endpts, maybe good. Rivipansel vaso-occlusive crisis in phase III with Pfizer. put NASDAQ IPO photo on about us page #adjuvanttherapy


Trilaciclib is a first-in-class short-acting CDK4/6 inhibitor to preserve hematopoietic stem cells during chemo. Positive Phase 2. MCap already high 1B. Insider selling OK. A MedImmune venture #adjuvanttherapy


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


New route injection to the back of the eye through the Suprachoroidal Space (“SCS”) for uveitic macular edema, can combine with Avastin or Eylea for Retinal Vein Occlusion etc. #procedure


Phase III failure. Angiogenesis-specific sensor (VBL’s PPE-1-3x proprietary promoter in Adeno 5 vector) with gene payload to specifically induce cell death in angiogenic endothelial cells in the tumor milieu. #AAV #genetherapy

DVAXHalf hour sell off after ER, then reverse.2018-03-08
ACRXMeeting minutes not surprised. Zalviso sales will be slow until 2019.2018-03-08
XENENav1.7 inhibitor rare mutation no Pain. Topical didn't meet endpt. Genentech working on oral selective inhibitor.2018-03-08
RoivantVivek Ramaswamy’s public companies. Model: take big companies low priority drugs and develop it separately (reduce "traffic jam”), new venture for Diabetes: Metavant2018-03-08
Refuse to filemanufacture related; production record (ACOR); device information (STDY); additional information.2018-03-08
OTICOTIVIDEX is a sustained-exposure formulation of the steroid dexamethasone for Ménière’s disease. Miss phase 3. No significant insider selling. Trading below cash value now. Valued $1B post IPO in 2015. Lukewarm MOA.2018-03-08
Commercial FailuresDNDN (8bil), MNKD (4bil)2018-03-08
ADROSTING pathway leader and other immunooncology2018-03-08
ACAD09.09 miss phase III; 2010 initiate new pIII; Nov. of 2012 met EP. Took 3 years and positive results to revive the stock. Be patient.2018-03-08
ABUSRegulus using LNP to deliver Anti-MiR for HCC. Gritstone/ALNY/SGMO/CRSP/NTLA/Generation Bio/Moderna/Regulus2018-03-07
RGLS4Q CC announced challenge recruiting patients to Alport trial, now enroll til 2H2018. ADPKD progress OK. Down big 20% next day.2018-03-07
OselMicrobiome therapy for vaginitis, inspired by Wen2018-03-07
GILDHIV shock and kill to reactivate reservoir2018-03-07
ABUSChat w. Dr. Saab Dr. Nazem Afdhal (Spring Bank)2018-03-05
AGRXWen Mao recommended Evofem. Its totally not as good as Agile. Still same market cap. 1) cheap ingredient 2) poorest category for efficacy 3) nobody will use.2018-03-05
DVAXSD-101 trial 7 sites withdrawn. Why? DV281 3 more 4/5 recruiting.2018-03-01
RubiusRed Cell Platform2018-03-01
PearPrescription digital medicine, app to manage neuro disease2018-03-01
CognitoTxBrain wave removes plaque Nature Podcast2018-03-01
DVAXAdd $1.2k@16.42018-02-28
ABUSGeneration Bio uses LNP to deliver ceDNA; Moderna now valued at $7.5B, possible $20B IPO2018-02-27
ACRXRead Acelrx received Day 180 questions to Feb CHMP during 19-23Feb. Add$1k@1.852018-02-27
AGRXAdd $1.2K(318)shares@$3.782018-02-26
Moderna19 pipeline; value at 7.5B pvt. 20B IPO?2018-02-26
SGMOZFN gene editting; GILD CAR-T deal; LNP license2018-02-24
RGLSWuxi STA manufacture partnership with RGLS.2018-02-22
DVAXACIP recommendation. 2.20.2018 $175M ($100M+75M optional) loan. Abstract submitted.2018-02-21
ACRXRBC conference. Zalviso will be delayed after Dsuvia resubmission by 1H18. 2.23.2018 FDA approved KMPH’s Opioid pain killer without abuse deterrent label2018-02-21
AIMTPhase III good, but pop then sell off the same day2018-02-20
APRItopical for ED. CRL for CMC and Safety2018-02-18
PCRXOld candidate using DepoFoam technology, approved since we studied; but share price kept falling since 2015. AdCom4-62018-02-17
ATRSPartner product for preterm birth approved2018-02-17
RGLSRead RGLS investor village board. Seems lots of speculation and not so much high quality post. Wait for TA and response to news.2018-02-16
DVAXNektar big deal with BMY for its IL2R(CD122) agonist.2018-02-14
ABUSCFO Departure after Roivant deal close and consolidation to PA. 2.14.2018 negotiating LNP joint venture with Roivant. People on IV are confused and split. Ambiguity aversion?:) 2.19.2018 No hearing listed on court website. 2.20.2018 Settled and Cancelled? 2.22.2018 Settlement announced. Only 4 Moderna vaccine sublicense survived.2018-02-13
OPKNow $3. Great decision I sold. Revenue declined!2018-02-12

Back to $1.5. Expect a long flat base.

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

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
ONCEAn-chieh told me. Heavy selling. Eye drug approved but hemophillia fell short. Share price halved2017-12-22
AGRXOrtho Evra had BMI warning.2017-12-20
ACRXRead posters 309 and other publications: better satisfaction and less failed analgesia; less oxygen desaturation; no active metabolite; no need to adjust dose due to comorbidity; no dose stacking.2017-12-19
RGLSRGLS4326 phase 1a in healthy volunteers initiated.2017-12-19
NVAXphase 3 failure. Used to worth 3.4B and $13 now 200M and less than $1. $300M debt financing red flag. Continue to disappoint2017-12-19
NLNKIDO drug pulled out promising combo data with Keytruda after disappointing news with Genentech earlier pullout. Skeptical. Crazy 2day rise. Later this rise phases away.2017-12-19
ABIOA tiny company with new beta-blocker; 17M Mcap, 8M Cash2017-12-16
EIGRLTB4 inhibitor for Pulmonary Hypertension; good chart2017-12-15
ACRXARX-04 NDA: no big change since. Different reaction compared to 2013 due to different market condition and ACRX expectation2017-12-13
ARGXARGX-110 anti-CD70 for cancer; positive Phase II data at ASH 2017; more: anti-MET, anti-GARP2017-12-13
DVAXAdded to XBI index between 20170908-12112017-12-11
ABUSAdded to IBB index. Ladenburg Thalmann unloaded in 3Q2017.2017-12-11
ACRXType A meeting confirmed but delayed to End of January 2018; Zalviso Sep2017 patients count rose to new high of 1600 despite that hospital counts dropped to ~205 (due to trial ending in Spain and unexplained big decline in Italy). That means per hospital usage is rising, slowly yet. Total hospital in Europe more than 10,000.2017-12-11
BGNEFound moderate insider selling by CEO John Oyler2017-12-11
SAGEGABA NMDA CNS disease; Brexanolone failed in 1 trial (09.2017) but success in another (11.2017); then SG-217 success2017-12-09
RVNCBotox-like for skin wrinkling; aesthetics2017-12-09
RARXRaPharma; Complement C5/C5b inhibitor; as Alexion C5 inhibitor competitor2017-12-09
PTIProteostasis network2017-12-09
MLNTFusidic acid (approved in other countries) for ABSSSI. Small MCap even though one approed product2017-12-09
KALAMPP tech for better eye delivery; NDA; 7/20/2017 IPO2017-12-09
GALTGallectin inhibitors for NASH or Cancer2017-12-09
DVAXNaive fully enroll December 2017, non-naive early 2018, possible data release at ASCO2018; Sci-B-Vac (Nasdaq:VBIV) was merged on May 6 20172017-12-08
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
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
Submission #AcceptanceAnnounce AdComAdComPDUFA
2nd3.30/ (cancel 9.4)
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

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

ACRXSentiments on twitter (proven useless 10.12) are mostly skeptical short citing opioid crisis and commercial failure.2017-10-11
AGRXanalyst day, lots of competent collaborator; most analysts at the Analyst Day event are gentlemen. Gender gap in financial sector is an interesting factor in its valuation.2017-10-10
DEPOfound this previous candidate lost 80% value since 2015. Mostly chronic opioid pain products2017-10-10
ALNYRaised fund a few months before Patisiran data; Fitusiran fatal thrombosis; Patisiran great results. up 52%. 2017-10-08
ACRXFound competitor the Medicine Company’s IONSYS withdrawn with marginal 2016 full year sales.2017-10-07
RYTMIPO. First-generation MC4R agonists were small molecules that failed in clinical trials primarily due to safety issues—particularly increases in blood pressure—as well as limited efficacy. In contrast, setmelanotide is a peptide that retains the specificity and functionality of the naturally occurring hormone that activates MC4R. We are focusing setmelanotide clinical development on obesity related to six single gene-related (i.e., monogenic) MC4 pathway deficiencies.2017-10-07
MCRBUlcerative Colitis P1b for SER-287 results disappointing, especially clinical response; endoscopic and remission seems better2017-10-07
FENCSodium Thiosulfate for the prevention of ototoxicity from cisplatin in pediatric patients2017-10-07
ACRXGetting nervous. Saw latest PPT, zalviso accelerating in Europe. Zalviso.eu Website well designed.2017-10-03
ECYTLicensed P3 ready candidate from Germany; share price exploded from $1.4 to $6 in 2 days2017-10-03
ABUSRoivant Sciences $116M Investment convertible at $7.13 + 8.75% per year will be converted at 4th anniversary. 13D detail; all convert at $7.13, will have 49.9% shares, will not buy more or sell for 4 years. Lots of supermajority rules. A long term investor aiming for a buyout in 4 years. 78mil (83mil) ABUS shares without further dilutiion.2017-10-02
ACRXDSM SinoChem Pharma found Acelrx home page news page not available. Potential early approval? Speculation2017-10-02
DVAXRead Reuters rumor on HeplisavB deal. ABUS AASLD Ab#929 using HeplisavB; manufacture resumed2017-10-01
ABUSAbstracts out for AASLD: ARB1467+aPD1+Vaccine (That's basically HeplisavB!) PR out 10.32017-10-01
ACRXI feel uncertain and people on twitter feel uncomfortable with the rapid run-up.2017-10-01
ZYNEFirst and only synthetic cannabinoid, up on P2, retrace on tweet says same as placebo2017-10-01
ZGNX (Zogenix)Up 200% on epilepsy drug; Fenfluramine, a banned anti-obesity drug due to cardiovascular issue. Now good to treat seizures.2017-09-29
DVAXClinicalTrials.gov updated AZD1419 to "active not recruiting” on 9.22. Primary completion 9.3.20182017-09-28

First patient randomized.

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

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

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

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

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

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

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 (MIGN) 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

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

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

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.

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

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

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

bottom? at 40% cash value $1.55/shr

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

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.

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

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

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

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


4.27.2016 FDA postpone 8.5  FDA AdCom 9.2  FDA Cancel  9.4 Company responds 10.3 Company receives question  10.4 Adam Feurestein: 13 of 15 rejected comment: how many previous AdCom and CRLs? Statistics does not infer causality. Fake statistics.

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
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
ACRXCMO Pamela Palmer resume.2014-07-01
DVAXorignial IPO $7.5 ($75 after rev-split)2004-02-19