Constellation Pharmaceuticals presented some compelling data at ASH. In early results from 15 JAKi naive Myelofibrosis patients treated with a combination of BET inhibitor CPI-0610 and ruxolitinib, 12 (80%) achieved a Spleen Volume Response of at least 35% (SVR35). The numbers indicate 8/11 (73%) of the newly added patients had a response. This is a […]
Taking a BET on CNST
Constellation Pharmaceuticals is focused on the development of cancer therapeutics by targeting the epigenetic pathway. It has EZH2 and BET inhibitors in mid-stage clinical studies. Excitement in the stock is driven by the BET inhibitor CPI-0610. There is substantial interest in this class of compounds. While small biotechs often lead the way with novel targets, […]
Initiating: Turning Point Therapeutics
San Diego based Turning Point Therapeutics is an oncology focused biotech that completed a successful IPO in April this year, raising about $190M with pricing at $18/sh. As the stock continued to climb, TPTX quickly filed for a secondary on September 3rd, adding another $200M to its cash hoard. The company is now very well […]
ARQL- Quick Take
I have been following Arqule off and on for quite some time. The company has been reborn after so many lost years pursuing its failed MET inhibitor ARQ 197. Hopes are high for lead asset ARQ 531, a competitive inhibitor of BTK. Arqule also has a pipeline of 2 AKT inhibitors and an out-licensed FGFR […]
Zogenix Acquires Modis Therapeutics
Aug 27, 2019 by Jason Chew Zogenix announced yesterday that it is acquiring privately held Modis Therapeutics. It gains access to the late stage substrate enhancement therapy, MT1621, for the treatment of Thymidine Kinase 2 deficiency (TK2d). Zogenix is paying $250M upfront, consisting of $175M cash and $75M stock. Modis may also receive milestones of […]
Coverage Continuation- ARVN
Aug 23, by Jason Chew Arvinas is one of the newer names I’ve been covering. The company is developing a new class of drugs with a new modality known as Targeted Protein Degraders, coining the technology PROTAC (Proteolysis Targeting Chimera). PROTACs work in a completely different way from current small molecule drugs. Most of today’s […]
Coverage Continuation- ZGNX
Aug 19, 2019 by Jason Chew Zogenix ran into some unwelcome surprise this April when FDA kicked back its ZX008 (Fintepla) NDA with a Refuse to File letter. The two deficiencies cited were the lack of a non-clinical toxicology report and submission of an incorrect clinical dataset. The request for additional toxicology studies was unexpected; management believed […]
Coverage Continuation – ZYME
Aug 14, 2019 by Jason Chew Zymeworks is perhaps one of my favorite stocks. The small/mid cap Canadian biotech has expertise in bispecific antibody technology. Bispecifics are an exploding field, now with over 50 antibodies in the clinic. Their flexibility allows for a multitude of applications. Some analysts believe bispecifics will drive growth in the […]
Coverage Continuation: SAGE
It has been a long time since my last article, but with the forum down, there is a lot to catch up on. My coverage will focus on the eight stocks in my portfolio. These are: SAGE; ZYME; ZGNX; ARVN; AMRN; ARQL; CALA; AXSM. We’ll start with SAGE: Things continue to hum along for Sage […]
August 12th Biotech Update
Another week with another set of macro concerns. I was waiting to see if there would be any interesting biotech news but I guess not. There was some late last week but this morning seems driven by macro (your choice between Argentina and/or Hong Kong and/or China trade). I see little on the horizon that […]
DMD Data by Giant Pharma Pfizer Kept Sarepta In the Driver Seat with Superior Drug
Pfizer (PFE) presented its first set of data (n=6) from the mini-dystrophin gene therapy for DMD (PF-06939926) at the PPMD conference on June 28th. Much speculations surrounded Pfizer’s decision to report the dystrophin quantification using mass-spec. Sarepta (SRPT) has used WB-western blot since 2015 during the Eteplirsen FDA approval process. Sarepta has also used it in […]
June 25 Biotech Update
So that was unexpected. First, the market is down and sector is higher. Second, we got another large merger to digest. Obviously I will focus on the deal and its implications. 1. I need to go back and listen the conference call so there might be some additional insight later this week but this deal […]
May 6th Biotech Update
Not the best start to the week for the market with the surprise tariff news hitting the market. I would not be stunned for the effect to be muted given how frequently Chine trade news changes. For all we know progress will be made this afternoon and all will be good again. As such, my […]
Sarepta – LGMD2E Data May Become the Next Inflection Point
Sarepta Therapeutics (SRPT) has a long history with several inflection points through the years. Moving upward from a penny stock back in the days they used to be called AVI Biopharma, through the first inflection point and stepping under the spotlight with first real eteplirsen success, meeting the primary endpoint of increase dystrophin and achieving […]
PSTI – The Future Regenerative Medicine Leader – Trading Under the Radar
• Regenerative medicine company with late-stage studies in 3 indications • Ready to use GMP-certified manufacturing facility for PLX cells • Aging is often associated with debilitating medical conditions, massive unmet needs • Over 617 million people in the world are over 65 years old • Over 70 million people in the U.S. are over […]
Bria-IMT Combination Study with KEYTRUDA®: What the Early Data Show
BriaCell presented some data from the ongoing Phase IIa combination clinical trial of Bria-IMT™ with Merck’s (NYSE: MRK) KEYTRUDA® [(pembrolizumab)], as listed in ClinicalTrials.gov as NCT03328026, in advanced breast cancer at SABCS, as well as some additional monotherapy data. While the poster does not provide a lot of data on combination patients (as expected given […]
CEO Interview: Bellus Outlook Post the Positive Ph1 Chronic Cough Study
Back in August I published my deep dive report “Bellus – David vs. Goliath, Can BLU Deliver A Better Chronic Cough Drug Than Merck?” (Link) with a bull thesis stating that Bellus Health (TSX: BLU.TO) (OTC: BLUSF) have a good chance to pass the first true hurdle and achieve positive results from their clinical trial […]
Dave-Trading November 2018
*** David Sobek is a disciplined value investor. Using models, research, and fundamental data, David devises a value for biotech stocks, buys when significantly undervalued, and sells when significantly overvalued.*** As a reminder, this is my personal guide. You can alter it in accordance with your risk tolerance. >3 Standard deviations – No position 2-3 […]
Bria-IMT Combination Study with KEYTRUDA®: What to Know and Why
In a previous interview, BriaCell (TSX:BCT.V) (OTCQB:BCTXF) (or the Company)’s President and CEO, Dr. Bill Williams cited as a near-term catalyst data from the Company’s ongoing Phase IIa combination clinical trial of Bria-IMT™ with Merck’s (NYSE: MRK) KEYTRUDA® [(pembrolizumab) ], as listed in ClinicalTrials.gov as NCT03328026, in advanced breast cancer. Initiated in October, the study […]
Opinion: No, The Antibiotics Market Is Not Broken
In light of slow drug launches and disappointing sales, there is a growing chorus of voices saying the antibiotics drug market is broken; that the government must step in to save one of our most important resources. With no profits to pursue, it is said, companies will abandon antibiotics, leaving society vulnerable to the spread […]
