August 1 Biotech Update

The sector recovered a little yesterday from last week’s sell-off but ideally we would need to see the sector break into new highs. It seems highly likely that the sector tests the recent highs and the price action at that point is likely to be a strong signal of underlying strength. Given the fundamentals and […]

FDA GT Draft Guidance is Bullish for Sarepta's DMD Pivotal Trial

Yesterday July 11, 2018 the FDA FDA issues 6 new draft guidance documents for gene therapy, clinical development and manufacturing guidance. Human Gene Therapy for Rare Diseases – FDA Draft Guidance for Industry https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM610802.pdf   The FDA guidance noting the pre-existing antibody to GT, this is the strongest SRPT’s & Dr. Mendell point, choosing the AAVrh74 which […]

PSTI – Ahead of IC Phase-2 Top-Line Results

PLURISTEM (PSTI) a cell therapy company, developer of placenta-based cell therapy product candidates for the treatment of multiple ischemic, inflammatory and hematologic conditions, company I’m following for years.  Pluristem trading under the radar and getting even more interesting these days as they already enter late-stage trials in 3 indications, gained the FDA’s Fast Track Designation, EMA’s […]

Dave Trading – May 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 […]

SRPT Was and Still The DMD Gene Therapy Leader

Today after the market close, Solid Biosciences (SLDB) announced it has received notification from the U.S. Food and Drug Administration (FDA) that IGNITE DMD, its Phase I/II clinical trial for SGT-001 microdystrophin gene transfer in Duchenne muscular dystrophy (DMD), has been placed on Clinical Hold. The news sent SLDB share price down to $11.90 or […]

Celldex: Quick Take

Celldex has struggled for a couple years now since its brain cancer drug Rintega failed in 2016. In Q2 this year, results from a pivotal study of the gpNMB antibody drug conjugate, Glembatumumab Vedotin, may change the company’s fate. Glembatumumab is being tested in women with triple negative breast cancer with >25% gpNMB expression. Patients […]

Dr. James Wilson Paper About Safety Concerns, Is Not Sarepta’s Concern!

Today morning, most of the gene-therapy stocks including SLDB, AVXS, ONCE, RGNX, BOLD, ABEO and even SRPT Stumbled following Dr. James Wilson paper published online “Severe toxicity in nonhuman primates and piglets following high-dose intravenous administration of an AAV vector expressing human SMN” (link to the paper) highlighting the toxicity in NHP- non-human primate study. […]

Achaogen: Is It A Buy?

South San Francisco based Achaogen is on the verge of gaining FDA approval for its bacteria fighting drug Plazomicin. The decision date has been set for June 25 with an Advisory Committee (AdCom) meeting likely to occur in the April-May timeframe. If the rulings are positive, the drug will be launched this year. Plazomicin is […]

The Kodak Hail Mary

Kodak is just the latest in a series of companies that rescued a failing stock price by announcing a crypto-currency scheme. While there is a Kodak crypto-currency that will be launched, the more interesting part is the selling of ASIC bitcoin mining machines. The Kodak pitch is that you front $3400 for the machine and […]

What is the Difference (Crypto-Currencies)

What’s the Difference? There are hundreds and soon to be thousands of crypto-currencies. It is impossible to know them all but I want to highlight some of the important aspects of crypto-currencies in general and how these differ among the larger currencies. While interesting in terms of organizing the information, it also helps highlight important […]

What Drives the Bitcoin Market?

What is Bitcoin? To answer that question we need a good analogy as to what bitcoin actually is or what it is supposed to do. Bitcoin as a Digital Currency This is actually a more difficult question to answer that you think and the answer has implications as to what the appreciation means and how […]

The Bitcoin Bubble

Bitcoin is a bubble. Bitcoin is overvalued. There is a lot of hysteria about bitcoin but that is from both those drinking the koolaid as well as those screaming bubble all the time. It is easy to look smart and snarky and call it a bubble but I refuse to believe the world is that […]

Dave-Trading – December 2017

*** 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 […]