---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-197857"
form_type: "8-K"
ticker: "AXSM"
cik: "0001579428"
company_name: "Axsome Therapeutics, Inc."
filed_at: "2026-04-30T23:59:59+00:00"
generated_at: "2026-05-15T00:48:40.764436+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Axsome Therapeutics announces FDA approval of AUVELITY for Alzheimer's disease agitation

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-26-197857
- form_type: 8-K
- ticker: AXSM
- cik: 0001579428
- company_name: Axsome Therapeutics, Inc.
- filed_at: 2026-04-30T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1579428/000119312526197857/0001193125-26-197857-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1579428/000119312526197857/axsm-20260430.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-197857
- JSON: https://secwatch.observer/filing/0001193125-26-197857.json
- Plain text: https://secwatch.observer/filing/0001193125-26-197857.txt

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