Health and Healthcare

Acadia Posts Big Win With FDA Approval

Chris Lange

Published: March 30, 2016 9:10 am

Last Updated: January 13, 2020 11:22 am

Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) saw its shares on the rise again this week following an incredibly positive U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) vote. The company announced that the FDA’s PDAC voted 12 to two that the benefits of Nuplazid (pimavanserin) for the treatment of Parkinson’s disease psychosis (PDP) outweigh the risks of treatment.

Previously, 24/7 Wall St. pointed out how Merrill Lynch sees Acadia growing another 60%, in relation to this study.

The Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the Nuplazid New Drug Application (NDA) is May 1. The FDA has granted the Nuplazid NDA Priority Review status and designated Nuplazid for the treatment of psychosis associated with Parkinson’s disease as a Breakthrough Therapy.

About one million people in the United States and around four to six million people worldwide suffer from Parkinson’s disease. An estimated 40% of these patients have PDP, which is characterized by hallucinations and delusions, a diminished quality of life and significant caregiver burden.

Steve Davis, president and CEO of Acadia, commented:

We are very encouraged by the Committee’s positive vote today and look forward to working with the FDA as it completes its review of Nuplazid. If approved by the FDA, Nuplazid would be the first drug indicated to treat psychosis associated with Parkinson’s disease.

Shares of Acadia closed Tuesday up 17% at $23.81, with a consensus analyst price target of $44.80 and a 52-week trading range of $16.64 to $51.99. Following the release of this vote, the stock jumped another 24% to $29.60 in early trading indications on Wednesday.