---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-048036"
form_type: "8-K"
ticker: "AXSM"
cik: "0001579428"
company_name: "Axsome Therapeutics, Inc."
filed_at: "2025-04-01T23:59:59+00:00"
generated_at: "2026-05-24T00:47:51.976441+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Axsome's solriamfetol misses primary endpoint in Phase 3 MDD trial; subgroup with severe EDS shows improvement

## Summary
- Primary endpoint (change in MADRS total score) not met in overall MDD population.
- In prespecified subgroup with severe EDS (ESS ≥16), solriamfetol showed greater improvements vs placebo on multiple measures.
- Axsome plans to initiate a Phase 3 trial in MDD with EDS in 2025 based on subgroup results.
- Safety profile consistent with established safety of solriamfetol; no new signals.
- Approximately 50% of MDD patients experience EDS, highlighting unmet need.

## SEC filing metadata
- accession: 0000950170-25-048036
- form_type: 8-K
- ticker: AXSM
- cik: 0001579428
- company_name: Axsome Therapeutics, Inc.
- filed_at: 2025-04-01T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1579428/000095017025048036/0000950170-25-048036-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1579428/000095017025048036/axsm-20250401.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-048036
- JSON: https://secwatch.observer/filing/0000950170-25-048036.json
- Plain text: https://secwatch.observer/filing/0000950170-25-048036.txt

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