---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-083441"
form_type: "8-K"
ticker: "AXSM"
cik: "0001579428"
company_name: "Axsome Therapeutics, Inc."
filed_at: "2025-06-09T23:59:59+00:00"
generated_at: "2026-05-19T17:09:50.944107+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA refuses to file Axsome's NDA for AXS-14 (esreboxetine) for fibromyalgia; new trial required

## Summary
- FDA issued RTF letter; second placebo-controlled trial deemed inadequate due to 8-week endpoint and flexible-dose design.
- First trial (12-week, fixed-dose) accepted as adequate; both trials met primary endpoints with no efficacy concerns raised.
- Axsome will conduct a new fixed-dose, 12-week trial; initiation expected in Q4 2025.
- Delay extends approval timeline for potential treatment of ~17 million U.S. fibromyalgia patients.

## SEC filing metadata
- accession: 0000950170-25-083441
- form_type: 8-K
- ticker: AXSM
- cik: 0001579428
- company_name: Axsome Therapeutics, Inc.
- filed_at: 2025-06-09T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- 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/1579428/000095017025083441/0000950170-25-083441-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1579428/000095017025083441/axsm-20250609.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-083441
- JSON: https://secwatch.observer/filing/0000950170-25-083441.json
- Plain text: https://secwatch.observer/filing/0000950170-25-083441.txt

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