Trading the Trials and FDA Decision Calendar
The tables at my website links below feature an updated calendar of 80 expected FDA new product decisions and 89 pending clinical trial result estimates + pending FDA re-submissions.
Click here for a link to my previous FDA calendars and
click here for a list of 14 extreme trades of companies with market caps below $100M and pending new drug decisions at the FDA.
Below is a summary of the major updates on the calendars since I last posted and a two-week outlook of expected decisions. The past week was notable for FDA clearance to begin human testing of embryonic stem cells in addition to big pharma M&A, with Pfizer (PFE) putting its cash hoard to use and reportedly close to finalizing a deal to buy Wyeth (WYE) for 50 bucks per share.
1.) United Therapeutics (UTHR): UTHR clarified the PDUFA date for tadalafil NDA in the treatment of pulmonary arterial hypertension (PAH) as 5/24/09. The drug is better known to many as Cialis and is currently marketed for the treatment of erectile dysfunction and is being licensed from Eli Lilly (LLY) with expected pricing of $10,000 per year for PAH. UTHR also modified the ongoing Freedom M Trial of Remodulin oral drug monotherapy for PAH, with results now expected in 1H10.
2.) Osiris Therapeutics (OSIR): OSIR held a successful pre-BLA meeting with the FDA in mid-January to set the stage for the first regulatory submission for a stem cell therapeutic. Prochymal Phase 3 Results in the treatment of graft-vs-host disease (GvHD) are expected in 2Q09 and OSIR plans to ask for a priority review as part of a rolling BLA submission to speed up the potential path to approval. Last November, OSIR signed a
major deal with Genzyme (GENZ) to market the former's two late-stage adult stem cell treatments, Prochymal and Chondrogen.
3.) Geron (GERN): A
new era for embryonic stem cell research was ushered in yesterday as GERN surprised the market with FDA approval to begin testing its experimental treatment in a small Phase 1 study in 8-10 humans with spinal cord injuries. In the near-term, look for President Obama to reverse the former administration's ban on federal funding for embryonic stem cell research, fueling more stock price gains that include over 50% each for GERN + OSIR and over 100% for StemCells (STEM) in the past year.
4.) Alnylam Pharma (ALNY): ALNY received FDA approval to begin Phase 1 human clinical trials of an experimental treatment (ALN-VSP) for liver cancer based on its extensive RNA interference (RNAi) drug discovery platform, with patient dosing expected to begin in 1H09.
5.) KV Pharma (KV-A): Hologic's (HOLX) could receive a ruling by Monday for its Gestiva NDA for prevention of pre-term births in women with a previous occurrence, with KV set to buy the rights to the drug if it is approved.
6.) Sanofi-Aventis (SNY): SNY has a PDUFA date of 1/31/09 for its Multaq (dronedarone) NDA (priority review) for atrial fibrillation (a type of irregular heartbeat).
7.) Takeda Pharma (TKPHY): Takeda has a PDUFA date of 1/31/09 for its TAK-390MR (a proton pump inhibitor) NDA for the treatment of gastroesophageal reflux disease (GERD).
8.) Eli Lilly: LLY and Daiichi Sankyo (DSKYY) have a FDA advisory panel meeting scheduled for 2/3/09 to review their long overdue pending NDA for prasugrel (Effient) as a new blood thinner in the treatment of acute coronary syndrome (ACS) to compete with Plavix, which is a multi-billion dollar drug for SNY and Bristol-Myers (BMY).
$21.65 (01/24/09)
