{"schema_version":"secwatch.filing_event.v1","accession":"0001404644-24-000083","form_type":"8-K","ticker":"NGNE","cik":"0001404644","company_name":"Neurogene Inc.","filed_at":"2024-08-07T23:59:59+00:00","discovered_at":"2026-05-14T18:03:12.931560+00:00","generated_at":"2026-05-31T11:40:26.344929+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Neurogene receives FDA RMAT designation for NGN-401 gene therapy in Rett syndrome","bullets":["RMAT designation based on preliminary clinical evidence from ongoing Phase 1/2 trial showing potential to address unmet medical needs.","Designation provides Fast Track, Breakthrough Therapy benefits, and eligibility for Accelerated Approval and Priority Review.","NGN-401 previously selected for FDA START Pilot Program; interim low-dose efficacy data expected Q4 2024, high-dose data H2 2025.","CEO notes FDA commitment to expedite development; designation underscores therapeutic potential of NGN-401."],"urls":{"canonical":"https://secwatch.observer/filing/0001404644-24-000083","json":"https://secwatch.observer/filing/0001404644-24-000083.json","markdown":"https://secwatch.observer/filing/0001404644-24-000083.md","text":"https://secwatch.observer/filing/0001404644-24-000083.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1404644/000140464424000083/0001404644-24-000083-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1404644/000140464424000083/ngne-20240807.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T11:40:26.344929+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"}