{"schema_version":"secwatch.filing_event.v1","accession":"0001404644-24-000097","form_type":"8-K","ticker":"NGNE","cik":"0001404644","company_name":"Neurogene Inc.","filed_at":"2024-11-18T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.357253+00:00","generated_at":"2026-05-29T22:57:14.494633+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Neurogene reports serious hyperinflammatory syndrome in high-dose NGN-401 patient; high-dose cohort halted","bullets":["Patient dosed on Nov 5 with 3E15 vg dose developed life-threatening systemic hyperinflammatory syndrome; is in critical condition.","FDA allowed trial to continue with low-dose cohort (1E15 vg); no other treatment-related SAEs to date.","Five participants in 1E15 vg cohort had only mild AEs; no MeCP2 overexpression or ICV procedure-related AEs.","Neurogene paused high-dose enrollment and no longer expects to complete low-dose enrollment in Q4 2024 due to protocol updates.","Company proactively engaged FDA via START program; high-dose cohort permanently discontinued."],"urls":{"canonical":"https://secwatch.observer/filing/0001404644-24-000097","json":"https://secwatch.observer/filing/0001404644-24-000097.json","markdown":"https://secwatch.observer/filing/0001404644-24-000097.md","text":"https://secwatch.observer/filing/0001404644-24-000097.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1404644/000140464424000097/0001404644-24-000097-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1404644/000140464424000097/ngne-20241118.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T22:57:14.494633+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"}