The Adcom is over and Eteplirsen was voted down. A final decision still remains for approval. Much was discussed in the Adcom, the key arguments were over the following: 1. Adequacy of dystrophin creation. 2. Efficacy of 201/202 Trial vs Historical Controls Both are intertwined. Adequacy of dystrophin creation: FDA had little faith in […]
April 27 Biotech Update
This week seems to have started like last week. I think it was actually last Tuesday that the sector suddenly took a dive on no real news and yesterday was certainly not a good day. It remains to be seen if this weakness will continue as we are entering into earnings that could help the […]
April 21 Biotech Update
I think the best description of the sector is listless and uncertain. The price action has been mixed but more than anything else, there has been a significant lack of volume. No one wants to buy or sell biotechs and so they have been drifting with some good days and some bad days. We are […]
SRPT – Final thoughts ahead of the AdCom
Reaching the decision point… Today is the day we have to make decisions in SRPT position. As has been explained several times in the forum and CRG twitter private feed, the date of the panel is 04/25 and the FDA BD comes two days before the preliminary panel (2 business days), it should be […]
March 22 Biotech Update
It looks like the sector did not fall off a cliff and perhaps has been finding some support. We still have the recurring question of whether this is real buying or simply short covering. As has been the case, I fall in the camp that this is short covering at least among the smaller caps. […]
SRPT – YEAR 4 DATA ANALYSIS
YEAR 4 DATA ANALYSIS Review of Eteplirsen to treat DMD By: @boscaptn, et al. Compiled From SAREPTA Public Data For Week 216 (Year 4) of Study 201/202 for Exon 51 Disclaimer: NO FINANCIAL ADVICE – The Information in this report is provided for education and informational purposes only, without any express or […]
Cup O' Joe – SRPT AdCom
***Our trading analyst Joe Gantoss relies on knowing more, either through technical analysis & charts or DD & research.*** Thesis: Joe has done a lot of research on SRPT. Despite some FDA headwinds, he believes the AdCom will at least be moderately positive for SRPT. But there is some downside risk, so there is […]
Sarepta: Is Eteplirsen Dead?
This was originally going to be titled “Ahead of the AdCom” but that no longers seems fitting. The highly anticipated Advisory Committee meeting originally scheduled for Friday January 22 was canceled due to blizzard conditions. Extremely negative reviews in Briefing documents [link] from the FDA are leading many to expect a denial for Eteplirsen’s drug […]
January 21 Biotech Update
So we have some biotech to talk about (finally) and the sector had a nice rally off the lows yesterday but we are not out of the woods by a country mile. At this point, however, it looks to be setting up as at least a tradable bounce but more ideally we would want it […]
January 20 Biotech Stock Update
Not much news as most people wait on SRPT questions as the panel approaches but even then there will not be a lot of new information in the questions (yes, maybe it signals what the FDA is thinking but that is likely too much to ask for a set of voting questions but not impossible). […]
January 15 Biotech Update
I hope everyone enjoyed the move yesterday as it looks like it was only a quick respite to the relentless decline in 2016. Sentiment will eventually change but the hopes of a V shaped recovery are fading fast. If we can avoid making new lows, then there might be some positive to come out of […]
January 14 Biotech Update
So the sector has been struggling a little during JPM. I think many hoped (including me) that good news out of JPM would be a nice catalyst to flip sector sentiment but we essentially saw the opposite with all news (good and bad) being sold. At this point, it is clear that the selling has […]
January 5 Biotech Update
While the market recovered a little into the end of the day yesterday and had a slight positive bias this morning, it is still not looking too healthy. I am not sure if this is simply people selling or buyers being afraid to step in. In terms of the sector, I still think JPM will […]
November 25 Biotech Update
Trading is slow this week but news is not. Yesterday was better but I still think it is too early to call the sector back but at the very least I believe is has found its footing. Interestingly it seems that the SMID caps are outperforming the larger caps (finally) although they have a lot […]
November 20 Biotech Update
The sector still cannot gain real footing and follow positive days with additional positive days. That being said as long as the positive days either outnumber or have higher gains than the losing day loses, then we can churn higher (or at the very least churn sideways and build a nice base). I am sure […]
SRPT: Better The Devil You Know
The Bull/Bear tussle in Sarepta has been ongoing for years now. Long term investors have ridden a rollercoaster as excitement has inevitably been followed by disappointment. Its Exon 51 skipping drug eteplirsen is set for an Advisory Committee meeting January 22, 2016 with the PDUFA date tentatively set for February 26. A war of words […]
Sarepta Patent Issue – Ask The USPTO Reg Attorney
This week BioMarin (BMRN) announced it won the first DMD patent battle against Sarepta (SRPT) in a press release stating, "BioMarin Receives Favorable Ruling in the Use of Exon 51 Antisense Oligonucleotides Patent Interference". On the other hand, Sarepta press release said, "Sarepta Therapeutics Announces USPTO Decision in Patent Interference Case with BioMarin Pharmaceutical" […]
SRPT Breakout- A Quick Look At The Chart
Sarepta Therapeutics, Inc. (SRPT) – Nasdaq After three years of a roller coaster, Sarepta getting closer to the the real deal, started with the NDA acceptance by the FDA on August 25th and a PDUFA date set on Feb 26th, 2016, but still waiting for the final date of the FDA Advisory Committee (AdCom) that […]
May 20 Biotech Update
The market was off to a benign start but the sector seemed to take it on the chin (albeit on generally light volume). I am not sure why the selling to start the day as we generally seemed to have some positive news after the bell last night. I do not think it will accelerate […]
Chimera Research Group Catalyst Summary for March 2015
At the end of each month Chimera Research Group provides you with a monthly summary of TEN notable catalysts/events that have occurred during the past month. MARCH 2015: 1) Bristol-Myers Squibb Company (NYSE:BMY) announced that the FDA approved the expanded use of Opdivo to treat patients with advanced squamous non-small cell lung cancer (NSCLC). Approval came just over two […]
