{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-337644","form_type":"8-K","ticker":"AXSM","cik":"0001579428","company_name":"Axsome Therapeutics, Inc.","filed_at":"2025-12-31T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.811334+00:00","generated_at":"2026-05-16T11:54:02.975429+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":"FDA grants Priority Review to AXS-05 for Alzheimer's agitation; pre-NDA meeting supports AXS-12 narcolepsy filing","bullets":["FDA accepted sNDA for AXS-05 (dextromethorphan/bupropion) for Alzheimer's agitation; Priority Review with PDUFA date April 30, 2026.","Pre-NDA meeting minutes confirm data package sufficient for AXS-12 (reboxetine) in narcolepsy cataplexy; NDA submission expected January 2026.","AXS-12 has Orphan Drug Designation for narcolepsy, potentially providing 7 years US exclusivity if approved.","AXS-05 previously received Breakthrough Therapy designation for Alzheimer's agitation (June 2020)."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-337644","json":"https://secwatch.observer/filing/0001193125-25-337644.json","markdown":"https://secwatch.observer/filing/0001193125-25-337644.md","text":"https://secwatch.observer/filing/0001193125-25-337644.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1579428/000119312525337644/0001193125-25-337644-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1579428/000119312525337644/axsm-20251231.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:54:02.975429+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"}