---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-304039"
form_type: "8-K"
ticker: "AXSM"
cik: "0001579428"
company_name: "Axsome Therapeutics, Inc."
filed_at: "2026-07-15T11:05:15+00:00"
generated_at: "2026-07-15T11:10:11.419430+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Axsome's NDA for AXS-12 (reboxetine) for cataplexy in narcolepsy; PDUFA May 1, 2027

## Summary
- FDA accepted for filing Axsome's New Drug Application for AXS-12 (reboxetine) to treat cataplexy in narcolepsy.
- PDUFA target action date set for May 1, 2027.
- FDA indicated it does not currently plan to hold an advisory committee meeting for the application.
- Axsome Therapeutics (AXSM) announced the acceptance on July 15, 2026.

## SEC filing metadata
- accession: 0001193125-26-304039
- form_type: 8-K
- ticker: AXSM
- cik: 0001579428
- company_name: Axsome Therapeutics, Inc.
- filed_at: 2026-07-15T11:05:15+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1579428/000119312526304039/0001193125-26-304039-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1579428/000119312526304039/axsm-20260715.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-304039
- JSON: https://secwatch.observer/filing/0001193125-26-304039.json
- Plain text: https://secwatch.observer/filing/0001193125-26-304039.txt

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