Remlifanserin Phase 3 Misses Primary Endpoint, Acadia Shares Plunge 12%
ACAD sits 22% above its 52-week low of $19.69.
Summary
Acadia's Phase 3 topline results for remlifanserin in Alzheimer's disease psychosis missed the primary endpoint, with the 60 mg dose showing a -12.6 change vs -10.4 for placebo (p=0.0603). The 30 mg dose showed minimal improvement. The stock dropped 12% premarket to $22.50. The company plans to continue enrolling two ongoing Phase 3 studies with amendments, including removing the 30 mg arm. This is a major setback for a key pipeline asset, especially after the FDA granted Fast Track designation in July. The miss raises doubts about the drug's efficacy in a large market with no approved therapies.
At the time of this announcement, ACAD was trading at $23.95 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $4.4B. The 52-week trading range was $19.69 to $30.96. This news item was assessed with negative market sentiment and an importance score of 9 out of 10. Source: Dow Jones Newswires.