ACADIA Pharmaceuticals (NASDAQ:ACAD) is up 68% premarket on increased volume in reaction to successful results in a Phase 3 clinical trial, HARMONY, evaluating lead drug NUPLAZID (pimavanserin) for the treatment of dementia-related psychosis.
The study met the primary endpoint of a statistically significant longer time to relapse of psychosis compared to placebo based on a planned interim analysis so the study will be stopped early.
The data will be submitted for presentation at future medical conferences. The company expects to file a supplemental marketing application in the U.S. in 2020.
The FDA approved NUPLAZID in April 2016 for Parkinson’s disease psychosis.
A Phase 3 study in schizophrenia patients was unsuccessful.
Management will host a conference call this morning at 8:30 am ET to discuss the results.
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