---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-030395"
form_type: "8-K"
ticker: "AXSM"
cik: "0001579428"
company_name: "Axsome Therapeutics, Inc."
filed_at: "2025-03-03T23:59:59+00:00"
generated_at: "2026-05-25T17:43:59.147615+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Axsome gets FDA support for AXS-05 sNDA in Alzheimer's agitation; filing planned 3Q 2025

## Summary
- 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.

## SEC filing metadata
- accession: 0000950170-25-030395
- form_type: 8-K
- ticker: AXSM
- cik: 0001579428
- company_name: Axsome Therapeutics, Inc.
- filed_at: 2025-03-03T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- 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/1579428/000095017025030395/0000950170-25-030395-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1579428/000095017025030395/axsm-20250303.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-030395
- JSON: https://secwatch.observer/filing/0000950170-25-030395.json
- Plain text: https://secwatch.observer/filing/0000950170-25-030395.txt

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