{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-030395","form_type":"8-K","ticker":"AXSM","cik":"0001579428","company_name":"Axsome Therapeutics, Inc.","filed_at":"2025-03-03T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.059622+00:00","generated_at":"2026-05-25T17:43:59.147615+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Axsome gets FDA support for AXS-05 sNDA in Alzheimer's agitation; filing planned 3Q 2025","bullets":["FDA pre-NDA meeting minutes confirm existing data package supports supplemental NDA submission for AXS-05.","Axsome plans to submit sNDA in third quarter 2025 for AXS-05 to treat Alzheimer's disease agitation.","AXS-05 previously granted FDA Breakthrough Therapy designation for Alzheimer's agitation in June 2020.","Three positive Phase 3 efficacy trials (ADVANCE-1, ACCORD-1, ACCORD-2) all met primary endpoint on CMAI.","No deaths in AXS-05 patients; no increased risk of falls, sedation, or cognitive decline in long-term data."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-030395","json":"https://secwatch.observer/filing/0000950170-25-030395.json","markdown":"https://secwatch.observer/filing/0000950170-25-030395.md","text":"https://secwatch.observer/filing/0000950170-25-030395.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1579428/000095017025030395/0000950170-25-030395-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1579428/000095017025030395/axsm-20250303.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-25T17:43:59.147615+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"}