secwatch.observer — SEC 8-K summary
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Issuer:     ACADIA PHARMACEUTICALS INC (ACAD)
CIK:        0001070494
Form:       8-K
Filed at:   2021-08-04T23:59:59+00:00
Accession:  0001564590-21-040825
Event type: earnings
Sentiment:  negative
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Acadia cuts FY2021 NUPLAZID revenue guidance to $480-515M; FDA reiterates need for additional DRP studies
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- 2Q21 net sales $115.2M (+5% YoY); net loss $43.9M ($0.27/share) vs $42.1M loss in 2Q20.
- FY2021 revenue guidance reduced to $480-515M from $510-550M due to pandemic and higher gross-to-net (~20%).
- FDA Type A meeting on pimavanserin for DRP: FDA insists on additional studies per subgroup but open to further discussion.
- GAAP R&D guidance lowered to $250-270M (prior $280-300M); SG&A guidance unchanged at $385-415M.
- Phase 3 LAVENDER (trofinetide for Rett syndrome) top-line expected Q4 2021; Phase 2 ACP-044 pain results also Q4 2021.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1070494/000156459021040825/0001564590-21-040825-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1070494/000156459021040825/acad-8k_20210804.htm
  HTML page:      https://secwatch.observer/filing/0001564590-21-040825

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