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Acadia Depression Drug Misses Key Endpoint in Phase III Trial

Acadia Pharmaceuticals shares fell after the biopharma said a trial of a depression drug “didn’t achieve statistical significance on the primary endpoint.”
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Acadia Pharmaceuticals  (ACAD) - Get ACADIA Pharmaceuticals Inc. Report shares on Tuesday fell after the biopharma said that a Phase III study of pimavanserin as an adjunctive treatment for major depressive disorder “didn’t achieve statistical significance on the primary endpoint.”

The primary endpoint was “the 17-item Hamilton Depression Rating Scale (HAMD-17) total score change from baseline to week five.”

The company said: “Pimavanserin 34 mg given once-daily as an adjunctive treatment to standard antidepressant therapy was associated with a mean reduction of 9.0 in HAMD-17 total score compared to 8.1 for placebo as an adjunctive treatment (p=0.296).”

“We observed a consistent improvement of depressive symptoms over time with pimavanserin, but, unfortunately, the robust positive results from our Clarity-1 study were not replicated,” Acadia President Serge Stankovic said in a statement.

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“While these results do not support the product profile to pursue an additional Phase 3 study in adjunctive MDD, we will continue to analyze the data and the findings from our earlier positive depression studies as we assess next steps.”

Stifel analysts were unbowed by the news.

“While we are disappointed that the data are negative, we don't see depression as central to our buy thesis on the name," they said in a commentary according to Dow Jones. "A bigger deal is FDA acceptance of the Nuplazid sNDA in DRP.”

Acadia said Monday that the Food and Drug Administration accepted for filing its supplemental new drug application for Nuplazid, generically pimavanserin, a treatment of hallucinations and delusions associated with dementia-related psychosis.

Acadia shares recently traded at $44.43, down 20%. They remain about 3.9% higher in 2020 to date.