secwatch.observer — SEC 8-K summary
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Issuer:     Axsome Therapeutics, Inc. (AXSM)
CIK:        0001579428
Form:       8-K
Filed at:   2025-03-03T23:59:59+00:00
Accession:  0000950170-25-030395
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Axsome gets FDA support for AXS-05 sNDA in Alzheimer's agitation; filing planned 3Q 2025
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- FDA pre-NDA meeting minutes confirm existing data package supports supplemental NDA submission for AXS-05.
- Axsome plans to submit sNDA in third quarter 2025 for AXS-05 to treat Alzheimer's disease agitation.
- AXS-05 previously granted FDA Breakthrough Therapy designation for Alzheimer's agitation in June 2020.
- Three positive Phase 3 efficacy trials (ADVANCE-1, ACCORD-1, ACCORD-2) all met primary endpoint on CMAI.
- No deaths in AXS-05 patients; no increased risk of falls, sedation, or cognitive decline in long-term data.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1579428/000095017025030395/0000950170-25-030395-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1579428/000095017025030395/axsm-20250303.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-030395

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