Below is a summary of companies from the BioMedReports.com FDA Decision Date Calendar
which have market caps below $200M, making them ideal candidates for extreme stock price volatility trades as their decision dates become imminent.
Dyax Corp. (DYAX) secured a narrow approval from a FDA Advisory Panel in early February (with a 6-5-2 vote) for its Kalbitor (ecallantide or DX-88) BLA with a PDUFA date of 3/23/09, which is designated for priority review in the treatment of acute attacks of hereditary angioedema (HAE is a rare disorder marked by severe swelling which can be fatal if the throat area is involved).
The panel debated the need for an effective treatment for this rare, potentially dangerous condition against the 3% higher incidence of allergic reactions (13% versus 10%) in patients taking the drug along with questions about the data generated in the clinical trials. ViroPharma (VPHM) has a PDUFA date of 10/1/09 for its Cinryze C1 Inhibitor sBLA to expand its label to include the treatment of HAE.
BioDelivery Sciences (BDSI) - Onsolis approval is possible by mid-2009 (click here for my full article
) and the Company raised $6M in cash from partner Meda AB, representing a $3M expanded licensing agreement and a $3M advance of the $30M milestone payment upon FDA approval. The remaining $27M cash milestone payment on FDA approval for Onsolis represents nearly one-half of the Company's current market cap, in addition to royalties that will be received on product sales once the breakthrough cancer pain drug is on the market.
Discovery Labs (DSCO) has a 4/17/09 PDUFA decision date for Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants. DSCO received its third approvable letter for Surfaxin last May and submitted its complete response to the FDA in mid-October. The stock price dipped below a dollar after the FDA issued a six-month Class II review (as investors hoped for the shorter 60-day Class I review) for the NDA re-submission, but DSCO has rebounded to the mid-dollar range as the decision date nears and insiders have purchased over 338,000 shares of stock in the past six months.