secwatch.observer — SEC 8-K summary
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Issuer:     Axsome Therapeutics, Inc. (AXSM)
CIK:        0001579428
Form:       8-K
Filed at:   2026-04-30T23:59:59+00:00
Accession:  0001193125-26-197857
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Axsome Therapeutics announces FDA approval of AUVELITY for Alzheimer's disease agitation
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- AUVELITY (dextromethorphan HBr/bupropion HCl) approved for agitation associated with dementia due to Alzheimer's disease.
- First-in-class NMDA/sigma-1 receptor-targeted treatment; supported by Phase 3 ADVANCE-1 and ACCORD-2 trials.
- In ADVANCE-1, AUVELITY showed statistically significant improvement vs placebo on CMAI at Week 5 (primary endpoint).
- In ACCORD-2, AUVELITY significantly delayed time to relapse vs placebo (up to 6-month double-blind phase).
- Safety profile: 1.3% discontinuation due to adverse events (same as placebo); common side effects: dizziness, dyspepsia.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1579428/000119312526197857/0001193125-26-197857-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1579428/000119312526197857/axsm-20260430.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-197857

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