{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-130755","form_type":"8-K","ticker":"AXSM","cik":"0001579428","company_name":"Axsome Therapeutics, Inc.","filed_at":"2024-11-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.859126+00:00","generated_at":"2026-05-29T17:51:00.737548+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Axsome's AXS-12 meets primary endpoint in ENCORE Phase 3 trial for narcolepsy with cataplexy","bullets":["Primary endpoint met: AXS-12 significantly reduced cataplexy attacks vs placebo (p=0.017); placebo worsening +10.29 attacks/week vs +1.32 with AXS-12.","Improvements in cognition and overall narcolepsy: NSAQ ability to concentrate (p=0.011) and PGI-C global improvement (p=0.024) both significant.","During open-label, 72% achieved ≥50% cataplexy reduction at 1 month, 82% at 6 months; mean ESS reduced 5.6 points at 1 month, 7.3 at 6 months.","Company plans to expedite NDA filing and request pre-NDA meeting with FDA; Orphan Drug Designation grants 7-year exclusivity upon approval."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-130755","json":"https://secwatch.observer/filing/0000950170-24-130755.json","markdown":"https://secwatch.observer/filing/0000950170-24-130755.md","text":"https://secwatch.observer/filing/0000950170-24-130755.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1579428/000095017024130755/0000950170-24-130755-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1579428/000095017024130755/axsm-20241126.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T17:51:00.737548+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"}