---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-21-362806"
form_type: "8-K"
ticker: "ACAD"
cik: "0001070494"
company_name: "ACADIA PHARMACEUTICALS INC"
filed_at: "2021-12-21T23:59:59+00:00"
generated_at: "2026-06-27T23:10:40.015245+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-21-362806
- form_type: 8-K
- ticker: ACAD
- cik: 0001070494
- company_name: ACADIA PHARMACEUTICALS INC
- filed_at: 2021-12-21T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1070494/000119312521362806/0001193125-21-362806-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1070494/000119312521362806/d276846d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-21-362806
- JSON: https://secwatch.observer/filing/0001193125-21-362806.json
- Plain text: https://secwatch.observer/filing/0001193125-21-362806.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.