Below are current tactical and strategic thoughts on approaching FDA and clinical trial catalysts for select names. Estimates, values and views are as of the date published (or are noted), are subject to potential future, pre-catalyst revision and are not intended as investment recommendations. Please read our Disclaimer: (1) Catalyst Watch List: CNAT: I continue […]
September 26 Biotech Update
Well, we have some more news today but still not a ton. I wanted to get out a quick and early note because I will be busy the rest of the day. The market seems to have no memory from day and day and is really trying to find a direction. I still lean towards […]
September 25 Biotech Update
It was a quiet news day on the biotech front and the market was quite weak early. Going into that environment I would expect a continued selling of biotechs but they seemed to hold up rather well. Perhaps I am focusing too much on the strength in GILD but even without that performance, biotechs seemed […]
[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 […]
September 24 Biotech Update
After a fairly weak start to the week, the sector seemed a little stronger this morning but the markets are teetering on a much larger correction. At this point, however, the markets may be oversold enough to get a near term bounce. The key is whether that bounce will be significant enough to push the […]
Update on previous coverage
After a while since our last update on these stocks, we wanted to provide an update to our readers on their recent developments and what to expect in the future. Stemline (STML) The company’s shares had an excellent post-IPO performance as a result of the positive data of its drug SL-401, a modified dyphtheria […]
[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 […]
September 22 Biotech Update
The sector really seems bifurcated at this point. While the large caps have been pretty reliable winners the past couple of months, it seems like they are taking a break. Obviously, they are still close to their highs but more often than not they appear to struggle to gain and when they do the gains […]
Catalyst Watch – Vol. 2, Edition 27 (9/19/14)
Below are current tactical and strategic thoughts on approaching FDA and clinical trial catalysts for select names. Estimates, values and views are as of the date published (or are noted), are subject to potential future, pre-catalyst revision and are not intended as investment recommendations. Please read our Disclaimer: (1) Catalyst Watch List: CNAT: Holding shares […]
[Free Report] Flexion Receives Clinical Hold; Merck KGaA Looks to Partner Immuno-Onc Drug
Flexion Therapeutics announced the FDA informed the company yesterday that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase IIb trial evaluating FX006 in patients with osteoarthritis (OA) of the knee. Flexion has not yet received written notice of the hold, but verbal communication from the FDA indicates it […]
September 18 Biotech Update
Seems like a mixed day for the sector with the broader markets offering a nice background for gains but the biotech sector is not really rallying as you would expect. It is still early and I am not sure there is too much to read into this but one would prefer to see a more […]
[Free Report] Endo Makes Bid For Auxilium; Gilead Fails Pancreatic Cancer Trial
Endo International made an unsolicited proposal yesterday to acquire all the outstanding shares of Auxilium Pharmaceuticals for $28.10 per share in a mixed cash and stock transaction valuing the company at $2.2 billion. Endo intends on funding the deal with existing cash as well as debt financing. Endo expects the addition of Auxilium to be […]
September 17 Biotech Update
The sector rallied yesterday and seems to be trying to continue the move this morning. I think we are in no man’s land at this point as a lot of stocks are getting close to lines of resistance (for instance, GILD and CELG are both approaching the 20 day SMA). Will we pause and breakout […]
[Free Report] SIGA Files for Bankruptcy; NeuroDerm Files for IPO
SIGA Technologies filed for Chapter 11 bankruptcy protection Tuesday as it seeks time to appeal a court order favoring PharmAthene. In an earlier ruling, the Delaware Court of Chancery found SIGA had failed to execute its licence agreement with PharmAthene relating to the smallpox drug Tecovirimar. SIGA believes the lump sum payment and damages it […]
[Free Content] Avanir Scores Positive Alzheimer’s Data; NPS Gets Nod From Panel
Avanir announced positive results from its Phase II trial evaluating the safety of AVP-923 in a 10-week study of 220 alzheimer’s patients. Treatment with AVP-923 resulted in a statistically significant reduction in agitation and caregiver burden. Complete data will be presented at the American Neurological Association’s (ANA) 2014 Meeting , October 12-14. The company plans […]
September 15 Biotech Update
We have a very weak start to the week as biotech buyers appear to have stepped aside. At this point, I think it is safe to say that we are in the midst of a correction and now the question is a matter of degree. We should be approaching an area of support, so it […]
[Free Report] Merck KGaA Ends Cancer Vaccine Trials; RTRX Takes Heat
Following the failure of tecemotide (formerly known as Stimuvax) in a Phase I/II study in Japanese patients, Merck has decided to discontinue all clinical development of the drug, including the Phase III START2 and INSPIRE non-small cell lung cancer trials. Tecemotide is a MUC1 antibody-specific immunotherapy licensed from biotech company Oncothyreon. It had previously failed […]
Recent Option Activity (9/10 ~ 9/11)
The following stocks had recent and notable activity in their options: $MRK (9/10): 12,800 JAN15 50.0 strike Calls were sold (stock at $60.56) for 10.70 or total proceeds of $13.7 million. This trade is likely part of a larger “dividend capture” strategy (see: http://www.businessinsider.com/options-dividend-trade-strategy-2012-9) and should be viewed as neutral (not bearish or bullish). $SNSS […]
September 12 Biotech Update
Another day and another bit of weakness in the sector and market. The longer that we churn along at these levels the more it looks like stocks are resting for a continuation of the main trend (higher). It is not a high conviction view but unless the market breaks to the downside soon, it looks […]
