1) Vion Pharma (VION.OB): Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA requesting approval as a single agent for remission induction treatment for patients age 60 and older with de novo poor-risk acute myeloid leukemia (AML). The NDA was filed 2/17/09, accepted by FDA for standard, 10-month review on 4/17/09 with a PDUFA decision date of 12/17/09.
2) Discovery Labs (DSCO): Surfaxin (lucinactant) NDA for 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 with an expected decision date of 4/17/09. 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, and recently traded all the way up to the $2.40 level. However, shares are down 20% during intraday trading todal on heavy volume exceeding 11M shares ahead of the expected PDUFA date on Friday.
3) Northfield Labs (NFLD): PolyHeme BLA (priority review) for life-threatening red blood cell loss. The FDA accepted the Company's BLA for PolyHeme and granted a priority review in the treatment of life-threatening red blood cell loss with a PDUFA date of 4/30/09. Shares are trading up 13% during intraday trading today on heavy volume of 1.5M shares as the decision date nears for PolyHeme.
Here's a link to 12 extreme trades on pending new drug decisions by the FDA for companies with market caps below $200M.
Disclosure: No positions.