{"schema_version":"secwatch.filing_event.v1","accession":"0001404644-24-000109","form_type":"8-K","ticker":"NGNE","cik":"0001404644","company_name":"Neurogene Inc.","filed_at":"2024-11-21T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.357692+00:00","generated_at":"2026-05-29T20:31:13.181145+00:00","sec_items":["7.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Neurogene patient dies after high-dose NGN-401; FDA allows trial to continue at lower dose","bullets":["Patient dosed Nov 5 with 3E15 vg NGN-401 died from hyperinflammatory syndrome linked to high AAV exposure.","FDA permitted Phase 1/2 trial to continue using 1E15 vg dose for pediatric and adolescent/adult cohorts.","Neurogene will incorporate the 1E15 vg dose into future registrational trial design.","This is the same patient previously reported as critical; hyperinflammatory syndrome is rare and life-threatening."],"urls":{"canonical":"https://secwatch.observer/filing/0001404644-24-000109","json":"https://secwatch.observer/filing/0001404644-24-000109.json","markdown":"https://secwatch.observer/filing/0001404644-24-000109.md","text":"https://secwatch.observer/filing/0001404644-24-000109.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1404644/000140464424000109/0001404644-24-000109-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1404644/000140464424000109/ngne-20241120.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T20:31:13.181145+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"}