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 […]
October 31 Biotech Update
A strong start to the morning but this seems a lot like a short term blow off rally but we need to see how the week closes. If we can end the day near the highs then I think the rally has some more legs in the near term but a close near the lows […]
October 27 Biotech Update
The market started a little weak this morning and while I am sure you can find a reason (Ebola, EU stress tests, end of POMO, etc), the market has had a nice run and simply needs to consolidate. This is not to say that we start the consolidation today but this is getting stretched in […]
Sarepta at World Muscle Society: Follow-up
The only new data provided by Sarepta were various measures of lung function, including, including %predicted MIP, MEP, and FVC; all of which demonstrated stabilization through 144 weeks for the 12 boys in the treated population. Individual patient data were once again provided, this time at the 144 week time point. As the trend has […]
SRPT- A Squeeze In The Making
Sarepta Therapeutics, Inc. (SRPT)-Nasdaq Sarepta is preparing for a busy 4th quarter ahead of the NDA submission as confirmed again by the company’s CEO Chris Garabedian during the Morgan Stanley Healthcare Conference on September 10th. We received guidance in April from the FDA that outlined a very clear path-forward, which resulted in a plan […]
SRPT and SAGE: Quick Notes
Nice 36-month Natural history study (or “Pane Study”) in Duchenne published essentially confirming what’s pretty much already known- that boys age 7 and over decline more rapidly than those under 7. They had previously reported 24 month results. This study and the Eteplirsen study are largely comparable. Average age of the older boys subgroup are […]
[Free Report] Wellcome Grant to Fast-track Ebola Drug Trials
The Wellcome Trust announced it has awarded 3.2 million pounds ($5.25 million) in grant funding to a consortium led by Dr. Peter Horby in a bid to fast-track multiple clinical trials for experimental Ebola drugs in Africa. Included in this consortium are Mapp Pharmaceuticals, Sarepta, and Tekmira. Mapp and Tekmira made headlines recently when their […]
July 25 Biotech Update
Market is pulling back a little and taking everything with it. I think we will get a much better sense of how the sector is reacting to the large cap earnings next week as the stocks either pullback further, consolidate, or grind higher. Today I want to follow up on a couple of issues of […]
July 10 Biotech Update
It was clearly a bad day in the market and the sector. It is looking more and more likely that the long anticipated correction is here and the question now is how deep of a correction and how long will it last? I would not be surprised to see at least a 5% correction in […]
April 21 Biotech Update- Some Good News to Start the Week
You would think the morning after a holiday would not be too busy but I have been running around all morning trying to organize a number of different projects. Luckily there are really only two issues that I wanted to address today as they have import for both individual stocks but also perhaps for the […]
SRPT – FDA Says No To Sarepta AA
On Tuesday morning, Sarepta informed investors that in what appeared to be a change from its previous stance, the FDA was not supportive of the company’s planned Accelerated Approval filing for the DMD drug eteplirsen. Even more damaging, the agency not only called into question the legitimacy of dystrophin as a biomarker, but cast doubt […]
November 13-EOD
It is difficult to get a real sense of where the sector is going outside of down. Obviously one could draw the conclusion that sentiment is negative (and it is) but I am seeing more pockets of strength than the other days. What is difficult is that there does not really seem to be a […]
November 12- EOD
Well, I think it was more of the same in the sector writ large with the biggest news obviously being SRPT, which I will touch on below. I was surprised to see the small caps hold up as well as they did on the news and that is a slight positive for the sector going […]
October 7- EOD
Macro, macro, and more macro. That seems to be driving the market and without any significant biotech specific news that was the word of the day. As we get closer to the debt ceiling the greater the headwind and the closer correlation between stock movements will get to 1. Biotechs will be particularly vulnerable given […]
September 23rd EOD
It was a weak day in biotech (although it seemed to recover a little in the afternoon) and some of the biggest biotech bulls are turning cautious. Mike King of JMP was out with a note this morning talking about taking money off the table. He is still a long term biotech bull but thinks […]
