{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-275722","form_type":"8-K","ticker":"ENGN","cik":"0001980845","company_name":"enGene Therapeutics Inc.","filed_at":"2025-11-12T23:59:59+00:00","discovered_at":"2026-05-14T18:02:41.207993+00:00","generated_at":"2026-05-16T21:44:40.220042+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Detalimogene 62% CR at 6 months; primary endpoint changed; BLA on track H2 2026","bullets":["Post-protocol amendment patients achieved 62% CR at 6 months (n=37) and 63% at any time (n=62).","Primary endpoint for pivotal cohort changed to CR at any time following FDA discussions; duration of response is key secondary.","BLA submission for detalimogene planned in H2 2026; potential FDA approval in 2027.","Cash, cash equivalents and short-term investments of $202.4M as of Oct 31, 2025.","Safety: 42% patients had TRAEs, mainly Grade 1/2; no Grade 4/5; dose interruptions 1.6%, discontinuations 0.8%."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-275722","json":"https://secwatch.observer/filing/0001193125-25-275722.json","markdown":"https://secwatch.observer/filing/0001193125-25-275722.md","text":"https://secwatch.observer/filing/0001193125-25-275722.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1980845/000119312525275722/0001193125-25-275722-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1980845/000119312525275722/d28722d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T21:44:40.220042+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"}