secwatch.observer — SEC 8-K summary
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Issuer:     ACADIA PHARMACEUTICALS INC (ACAD)
CIK:        0001070494
Form:       8-K
Filed at:   2021-12-21T23:59:59+00:00
Accession:  0001193125-21-362806
Event type: regulatory
Sentiment:  neutral
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1070494/000119312521362806/0001193125-21-362806-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1070494/000119312521362806/d276846d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-21-362806

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer