I think we are entering a lull in the sector as we are approaching earnings seasons. In general, this tends to be a better season than the first but that also means expectations are a little higher. A good earning season would see no major misses and at least a couple beat and raises from […]
FDA GT Draft Guidance is Bullish for Sarepta's DMD Pivotal Trial
Yesterday July 11, 2018 the FDA FDA issues 6 new draft guidance documents for gene therapy, clinical development and manufacturing guidance. Human Gene Therapy for Rare Diseases – FDA Draft Guidance for Industry https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM610802.pdf The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 […]
July 11 Biotech Update
Apparently my effect is now hitting the broader markets as they are pretty weak today. It could be more trade tensions with the Trump administration amping up the trade war rhetoric with China but I would not discount my impact. That being said I would not be looking for the sector to trade green in […]
July 10 Biotech Update
So I stay away and the sector does well and now that I am back, let us see how it does. I apologize for any weakness that my return causes but the sector has been demonstrating some decent strength in the past days. On the positive side, it seems related to positive fundamental news and […]
SRPT – Building a Precision Genetic Medicine Powerhouse
Sarepta Therapeutics (SRPT) is attempting to build the most meaningful precision genetic medicine company in the world, and has laid out its strategy to investors of exactly how it plans to get there. It starts with Duchenne Muscular Dystrophy (DMD) and the goal of dramatically changing patients’ lives. The company may have just done that. […]
July 2 Biotech Update
Apparently I am the problem with the sector. I miss one day and the sector moves higher and now that I am back it is back to going lower. I would argue that today seems to be driven more by the broader market but it is still going down. On the positive, I will be […]
June 28 Biotech Update
I tried to hold out as much hope for the sector as possible but the selling has been non-stop since the false breakout. The first bit of selling made sense against a weaker market and a natural retest of the breakout but it has not stopped and one could possible argue that it accelerated. It […]
June 27 Biotech Update
We still might be able to salvage a bullish view but it is getting pretty difficult. Clearly the breakout did not occur but we are still in higher highs and higher lows position from the April lows but we cannot have another big sell off and maintain that view. On the positive side, we have […]
June 26 Biotech Update
Yesterday was a brutal day and the odds now favor it being a false breakout of the sector. I would not say all is lost as if we can bounce soon, we might be setting up a higher low but there is not a lot of room for error in the sector. 1. AKAO received […]
June 25 Biotech Update
This will be an interesting day to see if the breakout will be confirmed as real or confirmed as false. We are back testing the previous levels of resistance and without a bounce from these levels, then I doubt the sector can continue to move higher. The news this morning is not helping as there […]
PSTI – Placenta Stem-Cells Brings Hope to PAD-Peripheral Artery Disease Patients
Intermittent Claudication or as called IC is a peripheral artery disease (PAD) caused by fatty deposits that accumulate in the arteries of the leg and reduce blood flow to exercising muscle and is generally a reliable indicator of occlusive arterial disease, which lead to a discomfort, weakness and a leg pain after any effort like exercise, […]
June 21 Biotech Update
Sector strength continued and is clearly outperforming the broader market. While we have seen this happen for a couple days before, this feels more like a real breakout. Ideally, we would need to pullback and test the previous resistance and have it act as support to confirm the move but I suspect it would hold. […]
Dave-Trading – June 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 […]
June 20 Biotech Update
You would think replacing a computer would be an easy job, it apparently requires different layers of people and so not everyone was on campus yesterday. So at some point in the future I have to look forward to the computer replacement process to eat half of my day. In any case, at least the […]
June 19 Biotech Update
The trade war is taking a lot of the headlines and I am running out of time to write as they are replacing my computer soon, which will likely take a lot more time that it reasonably should but I wanted to write a quick note. 1. SRPT hit a grand slam. Not only did […]
June 18 Biotech Update
Nothing new to start the week outside of a pretty weak market. I am not sure what the catalyst outside of an extended market but it looks again like the sector is hitting resistance and unable to break out. Perhaps there is continued disappoint in term of the lack of deals but regardless of the […]
June 15 Biotech Update
EHA is here and there will be some updates that are of interest but for the most part, I do not see it as having a fundamental effect on the sector. The XBI is flirting with breaking above resistance but it is struggling at what looks like the third attempt to break higher at these […]
June 13 Biotech Update
The sector had a decent day, although participation was not great. We seem to be on the verge of breaking higher (at least in the XBI) but it will be difficult to do unless the rally is broader in its scope. Of course, one cannot complain too much given that we are generally moving higher […]
June 12 Biotech Update
Nothing too exciting in terms of market action yesterday. There was some relatively outperformance of large caps versus small caps but that was mainly due to the gene therapy carnage. This is once again going to be an interesting test of sentiment in that space. Gene therapy companies have been pretty much Teflon in that […]
June 11 Biotech Update
I missed out on how the sector traded at the end of the week but it seems like the large caps had the slight edge over the SMID. We are entering a period of what should be some low news days but we do have EHA this week, which could provide some data but it […]
