{"schema_version":"secwatch.filing_event.v1","accession":"0001404644-25-000070","form_type":"8-K","ticker":"NGNE","cik":"0001404644","company_name":"Neurogene Inc.","filed_at":"2025-06-30T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.181266+00:00","generated_at":"2026-05-18T12:28:46.989362+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Neurogene announces FDA agreement on registrational trial design for NGN-401 gene therapy in Rett syndrome","bullets":["FDA agreed on single-arm, open-label, baseline-controlled design; N=18 proposed; primary endpoint: CGI-I improvement plus gain of developmental milestone.","Phase 1/2 fully enrolled; 5 participants dosed in 1H2025; no HLH/hyperinflammatory syndrome observed at 1E15 vg dose.","First four participants achieved 23 developmental milestones across hand function, communication, and ambulation by 3–15 months.","Cash, cash equivalents & investments of $292.6M as of March 31, 2025; runway extended into early 2028.","Updated efficacy and safety data expected in second half of 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001404644-25-000070","json":"https://secwatch.observer/filing/0001404644-25-000070.json","markdown":"https://secwatch.observer/filing/0001404644-25-000070.md","text":"https://secwatch.observer/filing/0001404644-25-000070.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1404644/000140464425000070/0001404644-25-000070-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1404644/000140464425000070/ngne-20250630.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T12:28:46.989362+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"}