secwatch.observer — SEC 8-K summary
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Issuer:     Axsome Therapeutics, Inc. (AXSM)
CIK:        0001579428
Form:       8-K
Filed at:   2024-04-01T23:59:59+00:00
Accession:  0000950170-24-038894
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Axsome initiates Phase 3 ENGAGE trial of solriamfetol for binge eating disorder
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- Initiated ENGAGE Phase 3 trial of solriamfetol for binge eating disorder.
- Trial is randomized, double-blind, placebo-controlled with ~450 patients.
- Two doses (150 mg and 300 mg) vs placebo for 12 weeks; primary endpoint is change in binge eating episodes.
- First patient screened in March 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1579428/000095017024038894/0000950170-24-038894-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1579428/000095017024038894/axsm-20240328.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-038894

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer