{"schema_version":"secwatch.filing_event.v1","accession":"0001404644-25-000082","form_type":"8-K","ticker":"NGNE","cik":"0001404644","company_name":"Neurogene Inc.","filed_at":"2025-08-11T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.903365+00:00","generated_at":"2026-05-17T15:18:35.210522+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Neurogene reports Q2 net loss $22M; cash $274.5M, FDA agrees on registrational trial design for Rett gene therapy","bullets":["Net loss of $22.0M for Q2 2025 vs $18.5M in Q2 2024; R&D expenses $19.4M vs $15.7M.","Cash, cash equivalents and short-term investments $274.5M as of June 30, 2025; runway into early 2028.","FDA provided written agreement on key elements of Embolden registrational trial for NGN-401; sample size refined to propose 20 participants.","Completed dosing in Phase 1/2 NGN-401 trial; last 5 participants dosed in H1 2025; updated clinical data expected H2 2025.","No evidence of HLH/hyperinflammatory syndrome in any NGN-401 participant at 1E15 vg dose level as of press date."],"urls":{"canonical":"https://secwatch.observer/filing/0001404644-25-000082","json":"https://secwatch.observer/filing/0001404644-25-000082.json","markdown":"https://secwatch.observer/filing/0001404644-25-000082.md","text":"https://secwatch.observer/filing/0001404644-25-000082.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1404644/000140464425000082/0001404644-25-000082-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1404644/000140464425000082/ngne-20250811.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T15:18:35.210522+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"}