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 […]

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 […]

Briacell Interview

Chimera Research Group: What sets Briacell apart from other immuno-oncology approaches? Dr. William V. Williams, President and CEO of Briacell: Briacell is developing a novel cancer immunotherapy based on a cancer cell line called SV-BR-1-GM a.k.a. Bria-IMT™. It was originally taken from a breast cancer patient, and further genetically altered to express GM-CSF, a stimulator […]

SRPT – Again, WMS-2018 Dystrophin Data Beating the Market Expectation

Yesterday 10/04, at 7:00 am ET, Sarepta Therapeutics (SRPT) with Dr. Mendell released the biopsy data from the fourth patient including full 4 patients “Functional Data” from Argentina at #WMS2018 the 23rd International Annual World Muscle Society meeting Link to the full slide deck: https://www.sec.gov/Archives/edgar/data/873303/000119312518292068/d616670dex992.htm The after-hours share price reaction was wild swing, spiking up […]

Dave Trading – September 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 […]