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Acadia giving up gains as investors realize the "successful" mid-stage of pimavanserin failed to achieve the primary endpoint

  • ACADIA Pharmaceuticals (NASDAQ:ACAD +14.4%) is still ahead from yesterday but down almost 22% from its intraday high as investors scrutinize its announcement of positive Phase 2 results for lead product candidate pimavanserin for the treatment of psychosis in Alzheimer's disease (AD) patients.
  • The company reported that the trial met its primary endpoint of a statistically valid reduction in psychosis at week 6 versus placebo as measured by a scale called Neuropsychiatric Inventory-Nursing Home (NPI-NH). According to ClinicalTrials.gov, however, the efficacy time frame for the primary endpoint was 12 weeks. The company referred to the 12-week NPI-NH score as a secondary endpoint an outcome which pimavanserin failed to beat placebo.
  • Update: In a November 14, 2013 press release, the company stated that "key efficacy endpoints will be based on the change at week six from baseline" while additional exploratory endpoints would be based on 12 weeks' treatment, including the durability of response, which did not appear to be sustainable.

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