{"schema_version":"secwatch.filing_event.v1","accession":"0001404644-26-000006","form_type":"8-K","ticker":"NGNE","cik":"0001404644","company_name":"Neurogene Inc.","filed_at":"2026-02-26T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.999694+00:00","generated_at":"2026-05-15T23:29:52.381114+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Neurogene's NGN-401 receives FDA Breakthrough Therapy designation for Rett syndrome","bullets":["FDA granted Breakthrough Therapy designation for NGN-401, a gene therapy for Rett syndrome.","Designation based on interim Phase 1/2 data showing clinically meaningful, durable multidomain improvements.","Completion of dosing in Embolden registrational trial expected Q2 2026.","Company plans to present additional interim Phase 1/2 data in mid-2026.","NGN-401 also has RMAT, Rare Pediatric Disease designations; part of FDA START Pilot Program."],"urls":{"canonical":"https://secwatch.observer/filing/0001404644-26-000006","json":"https://secwatch.observer/filing/0001404644-26-000006.json","markdown":"https://secwatch.observer/filing/0001404644-26-000006.md","text":"https://secwatch.observer/filing/0001404644-26-000006.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1404644/000140464426000006/0001404644-26-000006-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1404644/000140464426000006/ngne-20260226.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T23:29:52.381114+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"}