{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-197857","form_type":"8-K","ticker":"AXSM","cik":"0001579428","company_name":"Axsome Therapeutics, Inc.","filed_at":"2026-04-30T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.506771+00:00","generated_at":"2026-05-15T00:48:40.764436+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Axsome Therapeutics announces FDA approval of AUVELITY for Alzheimer's disease agitation","bullets":["AUVELITY (dextromethorphan HBr/bupropion HCl) approved for agitation associated with dementia due to Alzheimer's disease.","First-in-class NMDA/sigma-1 receptor-targeted treatment; supported by Phase 3 ADVANCE-1 and ACCORD-2 trials.","In ADVANCE-1, AUVELITY showed statistically significant improvement vs placebo on CMAI at Week 5 (primary endpoint).","In ACCORD-2, AUVELITY significantly delayed time to relapse vs placebo (up to 6-month double-blind phase).","Safety profile: 1.3% discontinuation due to adverse events (same as placebo); common side effects: dizziness, dyspepsia."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-197857","json":"https://secwatch.observer/filing/0001193125-26-197857.json","markdown":"https://secwatch.observer/filing/0001193125-26-197857.md","text":"https://secwatch.observer/filing/0001193125-26-197857.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1579428/000119312526197857/0001193125-26-197857-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1579428/000119312526197857/axsm-20260430.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T00:48:40.764436+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"}