FDA Asks ACADIA Pharmaceuticals, Inc. (ACAD) to Skip Late Stage Study and File NDA After Successful Results
4/11/2013 7:35:28 AM
Acadia Pharmaceuticals Inc. (ACAD), a biotechnology company with $5 million in annual sales, rose 43 percent in early trading after saying it will gain a U.S. regulatory review of its lead drug sooner than anticipated. Acadia increased to $11.37 at 9 a.m. New York time. The shares had risen fivefold in the 12 months through yesterday. The San Diego-based company plans to apply for Food and Drug Administration review of pimavanserin by the end of 2014. The FDA agreed Acadia won’t have to conduct a final-phase trial that had been scheduled to begin later this month, the company said today in a statement. Instead, the company can use trial results and supportive data from other studies to seek the review of pimavanserin, which is intended to treat Parkinson’s disease psychosis.