secwatch.observer — SEC 8-K summary
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Issuer:     Axsome Therapeutics, Inc. (AXSM)
CIK:        0001579428
Form:       8-K
Filed at:   2025-03-25T23:59:59+00:00
Accession:  0000950170-25-044096
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Axsome solriamfetol Phase 3 ADHD trial meets primary endpoint (p=0.039)
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- AISRS total score reduced 17.7 pts vs 14.3 for placebo at Week 6 (p=0.039) with 150 mg dose.
- Key secondary endpoint CGI-S severity score also significant (p=0.017) for 150 mg solriamfetol.
- 53.5% of 150 mg patients achieved clinical response (≥30% AISRS reduction) vs 41.3% placebo (p=0.024).
- Onset of improvement observed as early as Week 1 (p=0.036) vs placebo.
- Company plans to initiate pediatric ADHD trial in 2025; safety profile consistent with prior studies.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1579428/000095017025044096/0000950170-25-044096-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1579428/000095017025044096/axsm-20250325.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-044096

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