Acadia Resubmits Pimavanserin US Application For Expanded Use In Alzheimer's Psychosis

Acadia Pharmaceuticals Inc ACAD has resubmitted its FDA supplemental marketing application for pimavanserin for hallucinations and delusions associated with Alzheimer's disease psychosis (ADP).

• This resubmission responds to the FDA's Complete Response Letter (CRL) to the supplemental marketing application initially submitted for a proposed indication for pimavanserin for dementia-related psychosis. 
• The resubmission provides additional analyses from two previously conducted clinical studies, HARMONY1 and Study -0192, to support a proposed indication for ADP and is intended to address the issues raised in the FDA's CRL.
• Related: Acadia Slims Nuplazid Label Expansion Application For Alzheimer's Disease Psychosis.
• Price Action: ACAD shares are down 0.15% at $27.24 during the market session on the last check Wednesday.