{"schema_version":"secwatch.filing_event.v1","accession":"0001404644-25-000088","form_type":"8-K","ticker":"NGNE","cik":"0001404644","company_name":"Neurogene Inc.","filed_at":"2025-10-09T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.321425+00:00","generated_at":"2026-05-17T04:10:19.305990+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Neurogene FDA agreement on Rett gene therapy registrational trial; Q4 2025 dosing start","bullets":["Completed FDA discussions on Embolden registrational trial protocol for NGN-401; first participant dosing planned in Q4 2025 across 13 U.S. sites.","New preclinical NHP data shows ICV delivery achieves superior brain biodistribution vs. IT-L at clinically relevant 1E15 vg dose; supports ICV route.","Phase 1/2 data: first 4 participants gained 23 developmental milestones across multiple domains, indicating multi-domain improvement.","ICV and IT-L show comparable peripheral organ transduction; no liver-sparing benefit to IT-L administration."],"urls":{"canonical":"https://secwatch.observer/filing/0001404644-25-000088","json":"https://secwatch.observer/filing/0001404644-25-000088.json","markdown":"https://secwatch.observer/filing/0001404644-25-000088.md","text":"https://secwatch.observer/filing/0001404644-25-000088.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1404644/000140464425000088/0001404644-25-000088-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1404644/000140464425000088/ngne-20251009.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T04:10:19.305990+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"}