{"schema_version":"secwatch.filing_event.v1","accession":"0001404644-24-000091","form_type":"8-K","ticker":"NGNE","cik":"0001404644","company_name":"Neurogene Inc.","filed_at":"2024-11-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.357044+00:00","generated_at":"2026-05-30T01:42:00.301495+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Neurogene reports positive interim efficacy data from low-dose cohort of NGN-401 gene therapy for Rett syndrome","bullets":["All 4 low-dose participants achieved a 2-point improvement on clinician-rated CGI-I scale from baseline.","Caregiver-completed RSBQ scores improved 28–52% from baseline; participants acquired developmental milestones not seen in natural history.","Low-dose NGN-401 well-tolerated with no treatment-related SAEs; emerging SAE noted in a third high-dose participant.","Initiated adolescent/adult cohort (age ≥16) and gained FDA alignment on potency assay and manufacturing scale-up for registrational trial.","Company discontinued CLN5 Batten disease program after RMAT application denial; evaluating options."],"urls":{"canonical":"https://secwatch.observer/filing/0001404644-24-000091","json":"https://secwatch.observer/filing/0001404644-24-000091.json","markdown":"https://secwatch.observer/filing/0001404644-24-000091.md","text":"https://secwatch.observer/filing/0001404644-24-000091.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1404644/000140464424000091/0001404644-24-000091-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1404644/000140464424000091/ngne-20241111.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T01:42:00.301495+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"}