The accompanying table [click to enlarge] includes 58 entries of expected clinical trial results in addition to pending FDA applications for new product approvals + a list of companies which will be required to re-submit their applications due to complete response letters from the agency.
See my recent article on 20 emerging healthcare stocks to watch in 2009 for more details on some of the companies included in the accompanying calendar, in addition to the following companies with near-term catalysts in the form of clinical trial results:
Sequenom (SQNM) is set for a busy month after its $41M bid to buy EXACT Sciences (EXAS) and pending results at the end of January for its SEQureDx fetal Down's syndrome diagnostic screening test.
InterMune (ITMN) is expected to release Phase 3 results next month for pirfenidone in the treatment of idiopathic pulmonary fibrosis.
An early 2009 FDA decision is expected for diabetes drug Byetta as mono-therapy for Type 2 diabetes and a 1H09 NDA filing is expected by Eli Lilly (LLY) for a more convenient once-weekly version (exenatide LAR) of the drug – also impacting Amylin Pharma (AMLN) and Alkermes (ALKS).
A Big Year for Weight Loss Drug Developers
Orexigen Therapeutics (OREX) sank last week on data for weight loss drug Contrave after reporting results that fell just short of a FDA benchmark compared to placebo. However, OREX is set to report data from three additional Phase 3 trials for Contrave around mid-year.
Arena Pharma (ARNA) is the next company expected to post results for its weight loss compound, lorcaserin, with Phase 3 data expected in late March. Finally, Vivus (VVUS) will report data from two Phase 3 clinical trials of weight loss drug Qnexa some time around mid-2009.
Coming Soon – Website for Healthcare Investors & Traders
Stay tuned for details on the launch of a new, full-featured website for investors and traders in the healthcare sector. The website will focus on pending FDA decisions, clinical trial results, and other catalysts for traders and investors of biotech, pharma, and diagnostic stocks. My blog will be moving to a new URL and the content will be integrated into the website.
$23.1 (01/11/09)
