- ACADIA Pharmaceuticals (NASDAQ:ACAD) is up 4% after hours on robust volume on the heels of its announcement of the start of a Phase 3 clinical trial, HARMONY, assessing NUPLAZID (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis, a Breakthrough Therapy-tagged indication.
- HARMONY will have a 12-week open-label stabilization period during which participants will receive a daily dose of 34 mg (20 mg if clinically justified) of pimavanserin. Afterward, those who meet prespecified criteria for treatment response will be randomized to continue to receive daily pimavanserin (34 mg or 20 mg) or placebo for up to 26 weeks. The primary endpoint is time to relapse in the double-blind period.
- NUPLAZID is currently approved in the U.S. to treat hallucinations and delusions associated with Parkinson's disease psychosis.
- The company will host a conference call today at 5:00 pm ET to discuss the study.
- Previously: Acadia giving up gains as investors realize the "successful" mid-stage of pimavanserin failed to achieve the primary endpoint (Dec. 20, 2016)
- Now read: Nuplazid Is All Set To Transform Acadia Pharmaceuticals' Fortunes In 2017
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