{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-140949","form_type":"8-K","ticker":"AXSM","cik":"0001579428","company_name":"Axsome Therapeutics, Inc.","filed_at":"2024-12-30T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.859365+00:00","generated_at":"2026-05-28T22:44:30.411729+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Axsome AXS-05 succeeds in ACCORD-2 Phase 3 for Alzheimer's agitation; ADVANCE-2 misses primary endpoint","bullets":["ACCORD-2 met primary endpoint: time to relapse delayed (HR=0.276, p=0.001); 3.6-fold lower relapse risk vs placebo.","ADVANCE-2 did not reach statistical significance on primary endpoint (CMAI change: -13.8 vs -12.6, p=NS); results numerically favored AXS-05.","No deaths, no increased falls, sedation, or cognitive decline in any trial; long-term safety in >300 patients for 6 months.","Three of four pivotal Phase 3 trials now positive; company plans NDA submission to FDA in second half 2025.","AXS-05 holds Breakthrough Therapy designation for Alzheimer's disease agitation since June 2020."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-140949","json":"https://secwatch.observer/filing/0000950170-24-140949.json","markdown":"https://secwatch.observer/filing/0000950170-24-140949.md","text":"https://secwatch.observer/filing/0000950170-24-140949.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1579428/000095017024140949/0000950170-24-140949-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1579428/000095017024140949/axsm-20241230.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-28T22:44:30.411729+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}