Health and Healthcare
Why Merrill Lynch Sees Acadia Rising Another 60%
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Shares of Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) surged early on Monday morning. This company is under the spotlight by the U.S. Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee, which is set to review data included in Acadia’s New Drug Application (NDA) for Nuplazid (pimavanserin) for the treatment of with Parkinson’s disease psychosis (PDP). Merrill Lynch gave its opinion as well and why this company could rise another 60%.
Although the Advisory Committee Meeting is scheduled for March 29, shares rose ahead of the meeting. Ultimately this committee will decide whether Nuplazid would be approved to treat psychosis in Parkinson’s patients.
Should Nuplazid gain the committee’s approval, its sales could exceed $1 billion, according to some analysts.
Looking even further ahead, the Prescription Drug User Fee Act (PDUFA) action date for completion of the FDA review of the Nuplazid NDA is May 1. The FDA has granted the Nuplazid NDA Priority Review status and designated it for the treatment of psychosis associated with Parkinson’s disease as a Breakthrough Therapy.
Merrill Lynch speculated on the committee’s vote as well:
We expect a positive vote given 1) Nuplazid does not interfere with underlying PD meds and 2) No approved therapies in PDP. We expect clinical meaningfulness of data will be a key topic of discussion for panel.
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