Transcept Pharmaceuticals, Inc.(Nasdaq: TSPT ) plummeted today to a year low. Pharmaceutical company said it expects a second rejection letter from the U.S. health regulator regarding its sleep disorder drug.
Transcept expects complete response letter on Intermezzo NDA
Transcept Pharmaceuticals announced that it expects to receive a complete response letter from the U.S. FDA regarding the resubmitted New Drug Application, or NDA, for Intermezzo, or zolpidem tartrate sublingual tablet, on or before July 14, the PDUFA date assigned by the FDA for completion of the Intermezzo NDA review. The FDA issues a complete response letter to indicate that the review cycle for an NDA is complete and that the application is not ready for approval. The Intermezzo NDA seeks approval to market Intermezzo for use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. This update from Transcept is based on a teleconference with the FDA held earlier today during which the FDA expressed continued concerns about the safety profile of Intermezzo based on information in the resubmitted NDA.
With only 5.7M free trading shares we’re playing a bounce here: