{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-011220","form_type":"8-K","ticker":"AXSM","cik":"0001579428","company_name":"Axsome Therapeutics, Inc.","filed_at":"2025-01-31T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.059009+00:00","generated_at":"2026-05-27T04:41:41.488307+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Axsome receives FDA approval for SYMBRAVO (meloxicam/rizatriptan) for acute migraine in adults","bullets":["SYMBRAVO approved by FDA for acute treatment of migraine; expected commercially available in ~4 months.","In MOMENTUM trial, 77% of patients did not require rescue medication within 24h; superior to rizatriptan on sustained pain freedom.","In INTERCEPT trial (mild pain), 85% of patients did not require rescue medication within 24h; pain freedom sustained through 24-48h.","Most common adverse reactions: somnolence and dizziness (2% vs 1%). Long-term safety from MOVEMENT trial over 12 months.","Patented MoSEIC technology provides 5x faster meloxicam absorption; patent protection through at least 2040."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-011220","json":"https://secwatch.observer/filing/0000950170-25-011220.json","markdown":"https://secwatch.observer/filing/0000950170-25-011220.md","text":"https://secwatch.observer/filing/0000950170-25-011220.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1579428/000095017025011220/0000950170-25-011220-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1579428/000095017025011220/axsm-20250130.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-27T04:41:41.488307+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"}