secwatch.observer — SEC 8-K summary
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Issuer:     Axsome Therapeutics, Inc. (AXSM)
CIK:        0001579428
Form:       8-K
Filed at:   2025-04-01T23:59:59+00:00
Accession:  0000950170-25-048036
Event type: other_material
Sentiment:  neutral
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1579428/000095017025048036/0000950170-25-048036-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1579428/000095017025048036/axsm-20250401.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-048036

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