Acadia Surges 22% After FDA Releases Briefing Documents

Shares of ACADIA Pharmaceuticals Inc. ACAD, a biopharmaceutical company that focuses on the development and commercialization of medicines for the treatment of neurological and central nervous system disorders, surged higher by more than 20 percent on Monday.

According to Fierce Biotech, Acadia Pharmaceuticals will face "some tough questions" on Tuesday when the U.S. Food and Drug Administration's advisory committee will review the company's antipshotic drug pimavanserin. However, the publication suggested the FDA's internal review document suggests that the "door is still open to a possible approval."

Fierce Biotech noted that while the FDA recognized that Acadia Pharmaceuticals' 34-mg dose of pimavanserin significantly improved symptoms of Parkinson's, there was also a "distinct" increase in the numbers of deaths and adverse events among patients.

"While the applicant will present evidence that the treatment effect represents a clinically meaningful change," Fierce Biotech quoted Mitchell Mathis, director of the division of psychiatry products as saying in the FDA report. "The Division's medical officer will present his interpretation of the same data and reach a different conclusion."

The FDA also added in its report: "As with the disproportionate increase of serious adverse events in the pimavanserin 34 mg daily group compared to the placebo group, there is no obvious unifying pathophysiologic process or unique adverse event that drives or dominates this disproportion."

"Like many other FDA reviews, the regulators in this case wanted to highlight the weaknesses in Acadia's case," Fierce Biotech stated. "But they accomplished that without sounding the kind of alarm that usually signals an odds-on rejection by the outside experts. This review will center on a risk/benefit analysis where there is no obvious outcome. And that should make Tuesday's panel review all the more interesting, as Acadia has a lot riding on the vote.