Acadia plans Q1 2022 sNDA resubmission for pimavanserin in Alzheimer's disease psychosis

ACADIA PHARMACEUTICALS INC

Resubmission targets Alzheimer's disease psychosis (ADP) instead of broader dementia-related psychosis.
sNDA includes data from two positive Phase 3 studies: HARMONY and -019, meeting primary endpoints.
New analyses address FDA complete response letter concerns; plan follows three meetings with FDA.
CEO Steve Davis says narrowed indication and additional data support case for first ADP drug approval.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.