Research analyst, medium-term horizon, biotech, small-cap

FDA Agrees To Expedited Path To NDA For Pimavanserin

By Jason Napodano, CFA

This morning, Acadia Pharmaceuticals (NASDAQ:ACAD) announced very positive news with respect to the timeline for filing the U.S. New Drug Application (NDA) for pimavanserin for the treatment of Parkinson's disease psychosis (PDP). Based on the solid data from the Phase III -020 study, first reported in November 2012 and most recently presented in poster form at the American Academy of Neurology annual meeting in March 2013, Acadia requested a type-C meeting with the agency to discuss the potential for filing the NDA based on -020, along with supportive data from the previous Phase III work conducted in the -012 and -014 studies.

According to management, this meeting took place last week. The conclusion...

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