secwatch.observer — SEC 8-K summary
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Issuer:     Axsome Therapeutics, Inc. (AXSM)
CIK:        0001579428
Form:       8-K
Filed at:   2024-03-19T23:59:59+00:00
Accession:  0000950170-24-033148
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Axsome doses first patient in PARADIGM Phase 3 trial of solriamfetol for MDD
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- First patient dosed in Phase 3 PARADIGM trial of solriamfetol for major depressive disorder.
- Randomized, double-blind, placebo-controlled trial with ~300 patients (1:1 ratio, 300 mg or placebo for 6 weeks).
- Primary endpoint is change in Montgomery-Åsberg Depression Rating Scale (MADRS).
- Solriamfetol is an investigational treatment; Axsome specializes in CNS disorders.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1579428/000095017024033148/0000950170-24-033148-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1579428/000095017024033148/axsm-20240319.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-033148

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