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Development-stage drugmaker Acadia Pharmaceuticals ( ACAD ) vaulted to a 12-week high in early trading Wednesday after an FDA panel voted late Tuesday in favor of approving its drug for Parkinson’s disease psychosis. The FDA had summoned an advisory committee of outside experts to evaluate Acadia’s Nuplazid, known generically as pimavanserin, as a treatment for hallucinations and delusions that afflict about 40% of Parkinson’s disease patients. While clinical trials had shown that is was effective in reducing the psychotic symptoms without worsening the symptoms of Parkinson’s (the major drawback of standard antipsychotics), the FDA had concerns about the drug’s safety, given that there was a significantly higher death rate among patients on the drug compared to the placebo group. The panel wound up voting 12 to 2 that Nuplazid showed a favorable risk/benefit profile, though they voiced concerns that will likely lead to the drug getting a “black box” label, which is the stiffest possible warning, wrote Leerink analyst Paul Matteis. “While FDA, and some panelists, noted that a 3-to-1 death imbalance on drug vs. placebo does not confirm an increased risk of death, FDA stated that the labels of new antidepressants and new antiepileptics warn against suicidality risk (like their predecessors) even if they don’t show this in clinical trials,” Matteis wrote in a research note. “When discussed, 4 of 6 panelists who explicitly commented on a black box were in favor of its presence, citing concerns surrounding not only safety, but also off-label use.” The FDA usually, though not always, follows the recommendations of these advisory panels. It’s due for a final decision — including on labeling — by May 1. Matteis affirmed his outperform rating on Acadia’s stock and price target of 40. Piper Jaffray analyst Charles Duncan maintained an overweight rating and lifted his price target to 44 from 39, noting that the vote bodes well not only for the May 1 decision, but for European Union approval later this year, as well as planned label expansions in Alzheimer’s disease psychosis and agitation. After a trading halt all day Tuesday, Acadia stock was up 13% in early trading on the stock market today , near 27. Image provided by Shutterstock . Scalper1 News
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