Acadia Pharmaceuticals Inc (NASDAQ: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.
