Shares of Neurocrine took another drubbing early today as investors digested the news that Pfizer is pulling out of its co-development pact for the sleep drug indiplon due to regulatory delays. Shares of Neurocrine lost more than a third of their value overnight. Neurocrine regains full control of indiplon, and Pfizer has agreed to support the program for another 180 days to ensure a "smooth transition."
Neurocrine stunned the market with its announcement in mid-May that the FDA had approved two low-dose versions of indiplon and issued a non-approvable letter for a 15 mg dose that is considered vital for its success. Its researchers say that the company may have to mount new clinical trials for the drug, which would significantly delay any marketing effort. Neurocrine plans to meet with the FDA to pursue talks concerning the drug and how it can be approved.
- here's the report on indiplon from MarketWatch