It was an intense week for SRPT’s investors, where the share price bounced from $74.36 (close Friday 03/09) to reach the high of $84.37 this week after the press release from Sarepta getting the green light from the FDA for Golo accelerated approval pathway (AA), and preparing to start the rolling NDA submission. Followed with […]
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 […]
Sarepta Official Statement Regarding The UK Study Halt
This morning, EP Vantage reported a temporary UK study halt in dosing after “one serious adverse event that could possibly be related to the investigational drug product” but the halt was for the UK only and did not include any other clinical trial which include Belgium, Czechia, France, Germany, Israel, Italy, Spain, Sweden, and the United States. […]
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 […]
SRPT – Preparing For Blast Of Catalysts
Already a year has passed since Sarepta’s first drug Exondys51 was granted FDA approval on 09/19/2016. The landmark decision by Janet Woodcock, despite the review team’s opposition, gave hope to all the kids with DMD (Duchenne Muscular Dystrophy) Exondys51 is in the middle of a great launch, one of the most successful first-year launches of […]
Dave-Trading October 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 […]
Dave-Trading – September 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 […]
Dave-Trading August 2017
Dave Trading – August 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 […]
Dave Trading – July 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 […]
June Dave- Quick Trade Update – ESPR
I tweeted earlier that ESPR was crushed because of what seemed like an innocuous employee benefit (I made the tweet Friday, it published today). That was all I had on my newsfeed. It turns out HC Wainwright released a bear statement that was addressed by ESPR in a later blog post. The HC Wainwright note […]
Dave-Trading June 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 […]
GILD Earnings Trade Idea
Let me preface this by saying that trading earnings is a scary proposition. Earnings tend to move stocks a lot, particularly when catalysts for the stock tend to be earnings based. It is also a fool’s game to try to use option pricing as a gauge for how much the stock will move for earnings. […]
Dave-Trading – May 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 […]
