Acadia Pharmaceuticals Inc. (ACAD - Free Report) closed on the day 17% up, even reaching highs of over 22% during afternoon trading. During pre-market trading hours today, the company’s stock gained over 15%.
The primary reason for this active and positive trading day is that the Food and Drug Administration (FDA) briefed the upcoming Psychopharmacologic Drugs Advisory Committee (PDAC), meeting tomorrow, about a priority review of Nuplazid, an Acadia Pharmaceutical product.
The document showed positive signs for the drug’s future conduct, as the FDA emphasized the benefits compared to a placebo. According to Acadia’s website, Nuplazid is a “new chemical entity that we discovered and that has the potential to be the first drug approved in the United States for psychosis associated with Parkinson’s disease. “
The FDA highlighted that the company has submitted a New Drug Application (NDA) on the back of just one trial meeting primary endpoint, along with three other trials as supportive information. None of the three supportive trials showed statistical significance on primary endpoint.
According to multiple reports, the Division of Psychiatry Products (DPP) requires efficacy evidence from more than one trial. However, the FDA does have the authority to approve a drug based on one robustly positive trial.
Back in September of last year, Acadia submitted a NDA seeking approval for Nuplazid. The company provided positive results from its phase 3 pivotal study, which evaluated efficacy, tolerability, and safety of Nuplazid in patients suffering from Parkinson's, to aid in the application’s acceptance.
Acadia Pharmaceuticals has a Zacks Rank #3 (Hold) and as of 3:42 PM ET, its stock is up over 18%.
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