---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-103098"
form_type: "8-K"
ticker: "AXSM"
cik: "0001579428"
company_name: "Axsome Therapeutics, Inc."
filed_at: "2024-09-04T23:59:59+00:00"
generated_at: "2026-05-31T06:26:19.630867+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Axsome's NDA resubmission for AXS-07 migraine treatment; PDUFA date Jan 31, 2025

## Summary
- FDA acknowledged Class 2 resubmission of NDA for AXS-07 for acute migraine treatment.
- PDUFA goal date set for January 31, 2025.
- AXS-07 is a novel oral drug candidate for acute migraine.

## SEC filing metadata
- accession: 0000950170-24-103098
- form_type: 8-K
- ticker: AXSM
- cik: 0001579428
- company_name: Axsome Therapeutics, Inc.
- filed_at: 2024-09-04T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1579428/000095017024103098/0000950170-24-103098-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1579428/000095017024103098/axsm-20240904.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-103098
- JSON: https://secwatch.observer/filing/0000950170-24-103098.json
- Plain text: https://secwatch.observer/filing/0000950170-24-103098.txt

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