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 disorders, today announced that the New Drug Application (NDA) for NUPLAZID™ (pimavanserin) has been accepted for review by the U.S. Food and Drug Administration (FDA) and the agency has granted it Priority Review. ACADIA is seeking FDA approval of NUPLAZID for the treatment of psychosis associated with Parkinson’s disease. The FDA granted NUPLAZID Breakthrough Therapy designation for this indication in 2014.
The FDA grants Priority Review to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists. Priority Review accelerates the review timeline from 10 months to six months from the date of acceptance of filing. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of May 1, 2016.
“The FDA Priority Review designation underscores the potential for NUPLAZID to provide an important treatment to patients with Parkinson’s disease psychosis, a condition for which there is no FDA-approved therapy,” said Steve Davis, ACADIA’s President and Chief Executive Officer. “We look forward to working with the FDA during the review.”
NUPLAZID is a new class of non-dopaminergic antipsychotic that acts as an SSIA (selective serotonin inverse agonist), preferentially targeting 5-HT2A receptors. Through this novel mechanism, NUPLAZID has demonstrated significant efficacy in Parkinson’s disease psychosis.
According to the National Parkinson Foundation, about one million people in the United States and from four to six million people worldwide suffer from Parkinson’s disease. An estimated 40 percent of these patients have Parkinson’s disease psychosis, which is characterized by hallucinations and delusions, a diminished quality of life, and significant caregiver burden.
ACADIA’s NDA submission is based on data from a comprehensive development program assessing the safety and efficacy of NUPLAZID for Parkinson’s disease psychosis. The NDA includes data from the pivotal Phase III -020 Study, in which NUPLAZID showed statistical improvement on all primary and secondary efficacy endpoints with no worsening of motor function. Detailed results of the -020 Study were published in The Lancet. (Original Source)
Shares of Acadia are trading at $37.48, up $2.66 or 7.64%. ACAD has a 1-year high of $51.99 and a 1-year low of $26.57. The stock’s 50-day moving average is $35.21 and its 200-day moving average is $39.50.
On the ratings front, Acadia has been the subject of a number of recent research reports. In a report issued on September 16, J.P. Morgan analyst Cory Kasimov initiated coverage with a Hold rating on ACAD and a price target of $75, which represents a potential upside of 115.4% from where the stock is currently trading. Separately, on September 3, Needham’s Alan Carr reiterated a Buy rating on the stock and has a price target of $49.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Cory Kasimov and Alan Carr have a total average return of 0.9% and 24.2% respectively. Kasimov has a success rate of 52.7% and is ranked #1763 out of 3808 analysts, while Carr has a success rate of 55.8% and is ranked #32.
Overall, one research analyst has assigned a Hold rating and 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $49.00 which is 40.7% above where the stock closed last Friday.
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.