---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-140949"
form_type: "8-K"
ticker: "AXSM"
cik: "0001579428"
company_name: "Axsome Therapeutics, Inc."
filed_at: "2024-12-30T23:59:59+00:00"
generated_at: "2026-05-28T22:44:30.411729+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Axsome AXS-05 succeeds in ACCORD-2 Phase 3 for Alzheimer's agitation; ADVANCE-2 misses primary endpoint

## Summary
- ACCORD-2 met primary endpoint: time to relapse delayed (HR=0.276, p=0.001); 3.6-fold lower relapse risk vs placebo.
- ADVANCE-2 did not reach statistical significance on primary endpoint (CMAI change: -13.8 vs -12.6, p=NS); results numerically favored AXS-05.
- No deaths, no increased falls, sedation, or cognitive decline in any trial; long-term safety in >300 patients for 6 months.
- Three of four pivotal Phase 3 trials now positive; company plans NDA submission to FDA in second half 2025.
- AXS-05 holds Breakthrough Therapy designation for Alzheimer's disease agitation since June 2020.

## SEC filing metadata
- accession: 0000950170-24-140949
- form_type: 8-K
- ticker: AXSM
- cik: 0001579428
- company_name: Axsome Therapeutics, Inc.
- filed_at: 2024-12-30T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1579428/000095017024140949/0000950170-24-140949-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1579428/000095017024140949/axsm-20241230.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-140949
- JSON: https://secwatch.observer/filing/0000950170-24-140949.json
- Plain text: https://secwatch.observer/filing/0000950170-24-140949.txt

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