As a follow-up to my recent
article on nine extreme FDA trades of pending new product decisions among small and micro-cap companies, I have examined the
BioMedReports.com Clinical Trial Calendar database to find companies with market caps below $250M which have pending Phase 2 or 3 clinical trial results expected before the end of 2009. Below is a sample of 10 stocks meeting this criteria from the database of 111 entries included in the BioMedReports.com Clinical Trial Calendar, which is in addition to the 120 entries in the FDA Calendar database as of 5/13/09.
Amicus Therapeutics (NASDAQ:FOLD): Market Cap = $174M, Net Cash = $108M. FOLD expects to release Phase 2 clinical trial results during late 3Q09 for Plicera in the treatment of Gaucher disease. The Company also plans to announce the final Phase 3 clinical trial protocol and begin Phase 3 clinical development for Amigal (migalastat) in the treatment of Fabry disease during 2Q09.
Avanir Pharma (NASDAQ:AVNR): AVNR completed targeted enrollment on 3/16/09 of patients into the STAR trial, a pivotal Phase 3 trial of Zenvia (dextromethorphan/quinidine) in patients exhibiting signs and symptoms of pseudobulbar affect. The randomized, multi-center, international STAR trial is designed to compare the effects of Zenvia 30/10 mg, Zenvia 20/10 mg and placebo on involuntary crying/laughing episodes rates. AVNR expects to release topline data no later than end of 3Q09 and plans to submit a complete response to the FDA approvable letter during 1H10.
Arena Pharma (NASDAQ:ARNA): On 3/30/09, ARNA announced Phase 3 clinical trial results for its weight loss drug lorcaserin. While the results partly met FDA benchmarks, they still fell shy of a proposed FDA guideline that calls for at least a 5% point difference in weight loss between the test drug and placebo. The average weight loss for lorcaserin patients was 5.8% (12.7 pounds) versus 2.2% (4.7 pounds) for patients receiving a placebo for a difference of 3.6%, which is shy of the FDA's 5% standard.
