One Year After Gaffe, Acadia Gains FDA Nod For Parkinson’s Drug

Xconomy San Diego — 

Last year’s shakeup and mea culpa at San Diego’s Acadia Pharmaceuticals (NASDAQ: ACAD) has paid off. The FDA said late today it has approved Acadia’s pimavanserin (Nuplazid), a treatment for psychosis associated with Parkinson’s disease.

Acadia stumbled badly last year, as Xconomy reported here. The former CEO Uli Hacksell unexpectedly left the company, taking the fall for internal missteps that caused a delay in Acadia submitting its marketing application to the FDA for pimavanserin. On a conference call to announce the delay and Hacksell’s departure, interim CEO Steve Davis said, “Mistakes were made. The company should have been better prepared.”

Nine months later, in September, the company finally submitted its paperwork. Davis (pictured) was named permanent CEO and also joined the company’s board. He had come to Acadia as the chief financial officer in 2014 and was previously the COO at Heron Therapeutics and Ardea Biosciences.

The National Parkinson Foundation estimates that about 1 million Americans suffer from the debilitating neurological disease; about 40 percent of them are affected by Parkinson’s disease psychosis, in which patients experience hallucinations and delusions. There is currently no FDA-approved therapy for treating PDP, and the FDA has granted its “breakthrough therapy” designation for pimavanserin.

Because no other treatments are available, analysts have estimated that Acadia’s drug could eventually reach annual sales of $2 billion or more. Acadia shares are up 10 cents, less than a percentage point, in after hours trading.