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Monday, July 22, 2019

Acadia Pharma’s pimavanserin flunks late-stage schizophrenia study

ACADIA Pharmaceuticals (NASDAQ:ACAD) is poised for a down move in response to its announcement that adding lead drug pimavanserin to existing antipsychotic therapy in schizophrenia patients failed to demonstrate enough of a treatment effect compared to placebo in a Phase 3 study called ENHANCE.
Specifically, a measure of psychotic symptoms, a scale called PANSS, showed a “consistent trend in improvement” in the pimavanserin + current therapy cohort, but the separation from the placebo + existing therapy group fell short of statistical significance (p=0.0940).
Results from a subgroup of European patients were statistically valid as were measures of negative symptoms.
A Phase 2 trial, ADVANCE, in schizophrenia patients with predominantly negative symptoms should be completed shortly.
Management will host a conference call today at 5:00 pm ET to discuss the Phase 3 data.
Update: Shares are down 12% after hours.

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