Acadia Gets Expedited FDA Review Path for Lead DrugAnna Edney
Acadia Pharmaceuticals Inc., a biotechnology company with $5 million in annual revenue, surged to its highest value in five years after saying it will gain a U.S. regulatory review of its lead drug sooner than anticipated.
Acadia increased 64 percent to $13.10 at the close in New York, the highest price since February 2008. 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, Acadia 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.
“We are very pleased with the outcome of our meeting with the FDA, which we expect will reduce substantially both the time and cost of our PDP development program,” Uli Hacksell, Acadia’s chief executive officer, said in a statement.
Pimavanserin is a once-a-day pill Acadia is studying to treat a loss of contact with reality that includes hallucinations that can accompany Parkinson’s disease.
Acadia shares rose almost eightfold in the 12 months through today.