FDA Calendar Stocks On The Move: DSCO, VION, NFLD
Below is a summary of updates to the
BioMedReports.com database of 241 entries included in the
FDA and Clinical Trial Calendars.
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.
The above story is the opinion of the author only and it does not reflect
iStockAnalyst opinion. Further, the author is not personally advising you
regarding the suitability of the story for your investment needs. In no event
iStockAnalyst will be liable for any loss or damage including without
limitation, indirect or consequential loss or damage, or any loss or damage
whatsoever arising from or arising out of, or in connection with the use of this
information. Please consult your investment advisor before making any investment
decision.