---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-337644"
form_type: "8-K"
ticker: "AXSM"
cik: "0001579428"
company_name: "Axsome Therapeutics, Inc."
filed_at: "2025-12-31T23:59:59+00:00"
generated_at: "2026-05-16T11:54:02.975429+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA grants Priority Review to AXS-05 for Alzheimer's agitation; pre-NDA meeting supports AXS-12 narcolepsy filing

## Summary
- FDA accepted sNDA for AXS-05 (dextromethorphan/bupropion) for Alzheimer's agitation; Priority Review with PDUFA date April 30, 2026.
- Pre-NDA meeting minutes confirm data package sufficient for AXS-12 (reboxetine) in narcolepsy cataplexy; NDA submission expected January 2026.
- AXS-12 has Orphan Drug Designation for narcolepsy, potentially providing 7 years US exclusivity if approved.
- AXS-05 previously received Breakthrough Therapy designation for Alzheimer's agitation (June 2020).

## SEC filing metadata
- accession: 0001193125-25-337644
- form_type: 8-K
- ticker: AXSM
- cik: 0001579428
- company_name: Axsome Therapeutics, Inc.
- filed_at: 2025-12-31T23:59:59+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/1579428/000119312525337644/0001193125-25-337644-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1579428/000119312525337644/axsm-20251231.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-337644
- JSON: https://secwatch.observer/filing/0001193125-25-337644.json
- Plain text: https://secwatch.observer/filing/0001193125-25-337644.txt

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