ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced that thePsychopharmacologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) 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.
“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.”
The Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the NUPLAZID NDA is May 1, 2016. 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. (Original Source)
Shares of ACADIA closed today at 20.69, down $0.17 or 0.83%. ACAD has a 1-year high of $51.99 and a 1-year low of $19.21. The stock’s 50-day moving average is $29.82 and its 200-day moving average is $36.61.
On the ratings front, ACAD has been the subject of a number of recent research reports. In a report issued on January 22, Piper Jaffray analyst Charles Duncan upgraded ACAD to Buy, with a price target of $39, which implies an upside of 91.4% from current levels. Separately, on December 15, Leerink Swann’s Paul Matteis maintained a Buy rating on the stock and has a price target of $47.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Charles Duncan and Paul Matteis have a total average return of -7.1% and -39.5% respectively. Duncan has a success rate of 29.7% and is ranked #3300 out of 3594 analysts, while Matteis has a success rate of 0.0% and is ranked #3562.
ACADIA Pharmaceuticals Inc is a biopharmaceutical company. It is engaged in the business of development and commercialization of small molecule drugs for the treatment of central nervous system disorders.