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Acadia Pharmaceuticals Are Spiking

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Shares of ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) were trading higher by nearly 9 percent early Monday morning.

Acadia Pharmaceuticals announced after Friday's market close that the Psychopharmacologic Drugs Advisory Committee of the U.S. Food and Drug Administration will review data included in ACADIA's New Drug Application (NDA) for NUPLAZID™ (pimavanserin) for the treatment of psychosis associated with Parkinson's disease.

The advisory Committee Meeting is scheduled for March 29, 2016 and The Prescription Drug User Fee Act (PDUFA) action date for completion of the FDA review is scheduled for May 1, 2016.

The FDA has already granted NUPLAZID NDA Priority Review stats and designated the therapy for the treatment of psychosis associated with Parkinson's disease as a Breakthrough Therapy.

"Parkinson's disease psychosis is a debilitating condition for which there are no FDA-approved treatment options available to patients," said Steve Davis, ACADIA's President and Chief Executive Officer. "We look forward to discussing our data from the NUPLAZID clinical program with the members of the Committee."

Shares traded recently at $21.80, up 5.4 percent in the pre-market session.

Posted-In: ACADIA Pharmaceuticals Food and Drug Administration NUPLAZID PDUFA Psychopharmacologic Drugs Advisory CommitteeNews FDA Movers

 

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