Things got a little better for the sector with some green but we really need to get some momentum and accelerate to the upside. It is too easy for the bears to sell any rally and short without any real fear that the sector might move against a short position (or move against it more […]
June 4th Biotech (and MLP) Update
I would like to say something really interesting is happening in the sector or there is some great opportunity but the fundamental news is sort of like the sector- flat. It seems to me there is a dual whammy hitting the sector that is acting as some headwinds that are holding it back. First, MRNA […]
SRPT – Preparing for WMS-2018 Presentation
Tomorrow 10/04, at 7:00 am ET, Sarepta Therapeutics (SRPT) with Dr. Mendell are hosting a conference call from Argentina at #WMS2018 the 23rd International Annual World Muscle Society meeting, to present and discuss new data from the micro-dystrophin gene-therapy study Ph1/2. Link to SRPT webcast page: http://investorrelations.sarepta.com/events-and-presentations Back in June 19th at the R&D day SRPT […]
SRPT’s CEO Fireside Chat at Morgan Stanley Conference
Sarepta (SRPT) had a great run last week, a kick off following MS fireside chat, closing at $152.76 the highest “close” since June 21st (highest 52W close 06/20 was $153.69) on nice volume, but the highest “Weekly-Close” in the weekly chart (Close & not highest price point). Looking for a continuation next week, while the target […]
May 9 Biotech Update
Again not a day with a lot of news. There was a macro trade yesterday with the American withdrawal from the Iran deal as well as some heightened tensions between Israel and Iran. That macro hit the market a little but seemed to really impact the sector with the risk off. I suspect the Iran […]
March 15 Biotech Update
The PARP wars have ramped up with the AZN data. This was important data for the PARP wars but sort of important for the sector more broadly as this is a new class of drugs that seemingly has an impressive impact on the lives of patients. I think the PCSK9 data later this week are […]
November 15 Biotech Update
The initial move from the election seems long in the legs and perhaps is ready to pause. We have seen a couple of companies do secondaries, which is a perfectly rational and reasonable response. It has been an awful environment to raise cash, so many need cash and this is a nice time to refill […]
Eteplirsen: Reasonable Evidence of Efficacy
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 […]
BLCM: Limited Opportunities In a Changing Environment
The driving interest in Bellicum revolves around its safety switch for use in hematologic stem cell transplants. It’s product, BPX-501, is a T-cell therapy containing a caspase-9 gene that can be activated by the compound rimiducid, leading to cell apoptosis. BPX-501 is initially being positioned as an adjunct T-cell therapy for allogeneic HSCT. Stem […]
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" […]
2 Biotech Stocks In The Breakout Territory
Biotech traders have to adapt to any changes in the stock market, trying to adjust their trades and the game plan along with the markets condition. It is easier to take swing trades, long or short during a bull or bear market, but lately the choppiness and indecision hurt both longs and the shorts […]
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 […]
A Quick look – XBI In The Decision Zone
SPDR S&P Biotech ETF (XBI) We will maintain our focus on the XBI as the biotech barometer. Noticing lately the fact XBI is outperforming the IBB & the broader market SPY or SPX, might give us the sense that investors are again, willing to take more risk with the small-mid cap biotech companies after the […]
ESPR Quick Note
Esperion shares have fallen over 8% today as The Medicines Co and Alnylam released early data on their RNAi candidate, ALN-PCSsc, targeting PCSK9. The drug was shown to efficiently and safely reduce LCL-C when given subcutaneously. It was shown to maintain LCL-C suppression 140 days after a single 1.5 ml injection. The long duration of […]
Quick update from TRIL Presentation in Toronto
Trillium Therapeutics Inc. (TRIL) – Nasdaq Trillium Therapeutics presented at Bloomburton-2015 Healthcare Investor Conference in Toronto on May 5th, the speaker Dr. Rob Uger, TRIL’s Chief Scientific Officer (CSO) was very informative during the presentation, mentioned that TRIL are looking for a combination therapy with other immunological agents such as Approved cancer antibodies, T cell […]
[Free Content] TGTX in Pictures
TG Therapeutics has two programs, the CD20 targeting antibody TG-1101, and PI3K delta inhibitor TGR-1202. The focus of this post is on TGR-1202. Earlier coverage can be found here [link]. TG has been hesitant in giving out the structure of TGR-1202. It’s out now, so here it is below along with Idelalisib and IPI-145 […]
[Free Report] JNJ Aquires Alios: What This Means For Achillion
Johnson & Johnson announced today it will acquire privately held Alios BioPharma for $1.75 Billion in cash, gaining rights to the mid-stage treatment for infants with respiratory syncytial virus (RSV), AL-8176, and early stage nuc AL-335 for HCV. “We are excited that this acquisition will enable us to explore treatment options for a number of […]
[Free Report] Gilead Files NDA in Japan for HCV, Plans US, EU Filing for HIV
Gilead announced today it has submitted a New Drug Application (NDA) with Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval of a fixed dose combination of NS5A inhibitor ledipasvir and nucleotide analog polymerase inhibitor sofosbuvir for the treatment of patients with genotype 1 HCV. The NDA is supported by a Japanese Phase 3 study […]
[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 […]
[Free Report] Tekmira Authorized to Treat Ebola; Amgen Seeks Approval for BiTE
Shares of Tekmira are up over 15% midday on news the FDA has authorized the company to provide the drug TKM-Ebola for treatment of subjects with confirmed or suspected Ebola virus infections under expanded access protocols. Tekmira has long been the subject of speculation over approval of its drug for the treatment of Ebola. The […]
