Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) shares rose sharply early Monday after the firm announced that its late-stage dementia study met its primary endpoint. Specifically, the results come from Acadia’s Phase 3 Harmony study evaluating pimavanserin for the treatment of dementia-related psychosis.
The study met its primary endpoint, demonstrating a highly statistically significant longer time to relapse of psychosis with pimavanserin compared to placebo in a planned interim efficacy analysis.
The firm is planning to meet with the U.S. Food and Drug Administration (FDA) regarding a supplemental New Drug Application submission in 2020, and the results from the Harmony study will be submitted for presentation at upcoming medical meetings.
Previously, the FDA granted Breakthrough Therapy Designation for pimavanserin for the treatment of dementia-related psychosis. No drug is currently approved by the FDA for the treatment of this condition.
Jeffrey Cummings, M.D., Sc.D., Director Emeritus of Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, commented:
Psychosis adds dramatically to the marked burden that dementia patients already carry and is one of the most challenging-to-manage aspects of the disease for caregivers. With no approved treatment options available today for dementia-related psychosis, the pimavanserin study results represent a meaningful advance that will potentially bring us a much needed therapy for this debilitating disease.
Shares of Acadia traded up more than 84% early Monday to $43.90, in a new 52-week range of $13.17 to $43.98. The consensus price target is $33.75.