US FDA Throws Acadia A Curveball On Nuplazid For Dementia Psychosis
Complete Response Letter Requires More Data
Acadia strikes out on potential near-term sNDA approval in a broad dementia-related psychosis indication. The firm said the agency’s view has shifted from what was previously agreed upon.
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Deficiencies identified by the US FDA could delay the approval of pimavanserin for hallucinations associated with dementia-related psychosis, but Acadia did not have details for investors.