The sector did a little better yesterday but given the strength of the market, it is not a great performance. That being said another couple days in the green and perhaps this year will be different and we will not see the post-ASCO selloff. Obviously it is early but something to keep an eye on […]
June 1 Biotech Update
Happy ASCO days. The first day tends to be slow as news as it is information sessions, although later in the day we get some important CART data. In any case, by Monday we should have some interesting data to dissect. 1. CELG and BLUE have their BCMA CART data this evening. Expectations are high […]
Star Wars Day Biotech Update
We end the week on an OK set of news. It could certainly have been worse but nothing that is likely to fundamentally revalue the sector or reverse the chop. 1. SRPT finally reported the negative trend vote that most expected. As I also expected, there was a lot of notes talking about the expected […]
May 3 Biotech Update
There was a relative lull in the news yesterday and today but I would argue that the sector held up pretty well despite the GILD miss. That either means that GILD is less meaningful for the sector or that the drumbeat of disappointing earnings has priced in pretty negative views of the sector. In any […]
What Do You Need To Know Ahead of Next Week – SRPT CHMP Oral-Explanation
The CHMP meeting will take place next week April 23-26, we have no idea what day exactly is SRPT meeting, (Update 04/23: today the CHMP published this week agenda and SRPT Oral-Explanation set on 04/24 at 8:00 EST) . Usually after the Oral-Explanation the CHMP will ask the applicant representatives to step out from the […]
April 2 Biotech Update
Thursday was not a bad follow through for the sector. I am still not convinced that we are out of the forest quite yet but we are at least further away from the abyss that was staring at the sector earlier last week. This week looks to be quiet to start as there is not […]
March 21 Biotech Update
You would think the sector would have given us some more clarity by now but it still seems on the verge of breaking out or breaking down. The XBI could have put in a double top or is setting up a cup and handle pattern. Sentiment is not great as the reaction to Trump’s talk […]
SRPT – Preparing For The CHMP Oral-Explanation
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 […]
March 12 Biotech Update
An interesting start to the week thanks to the weekend news. I thought there would be a little more price action after the news but it is still early and perhaps this just signals how far PCSK9 has moved from investor interest. In any case, there are some interesting pin actions from the news. 1. […]
February 9 Biotech Update
The broader market looks heavy and it appears that if we end the day red that the weekly losses will be accelerating. Markets do not bottom on a Friday, so if we cannot have a real move higher today, then we will likely be lower again to start next week. We are obviously higher to […]
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. […]
January 26 Biotech Update
The market is relentless. Just as it is important to buy when the market seems to be going down forever, it is also important to sell on these sort of rips higher. The selling at the high levels is always more difficult for me, so I want to spend some time today talking about potential […]
January 3 Biotech Update
Yesterday had a nice start to the year, which seemed to be part of a broader rotation in the nasdaq. There was some “news” that I want to highlight but the bulk of today will be another non-consensus 2018 idea. 1. The FAERS released an update to its database of adverse events reports and it […]
Dave Trading – January 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 […]
November 20 Biotech Update
The news is winding down as we get closer to the holidays but there is some news today. For the most part, I do not expect a lot of news but there could be an M&A push to end the year if bankers need more deals for their bonuses. That being said I think we […]
November 15 Biotech Update
The sector continues to struggle and at least today we can blame the larger macro market but the fact is if the markets in general are going to correct, the sector is not going to hold up. I would not mind a broader correction as it likely would be the last leg in the biotech […]
October 27 Biotech Update
It has been an absolutely brutal earing season for the sector and for pretty good reason but you have also seen some babies being thrown out with the bathwater. Given the selling that has occurred, it is a natural reaction to assume these are buys or a bounce is coming but I prefer to sit […]
October 26 Biotech Update
A lot to discuss and I will do a couple quick hits and then focus on CELG as that seems the most fundamentally meaningful earnings report. This is going to take a couple days to really talk through all these reports but we will start with some high level points. 1. AMGN quarter was inline […]
