{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-109463","form_type":"8-K","ticker":"ENGN","cik":"0001980845","company_name":"enGene Therapeutics Inc.","filed_at":"2024-09-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:15.314458+00:00","generated_at":"2026-05-31T01:41:41.766244+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Detalimogene shows 71% CR rate in LEGEND pivotal cohort; well-tolerated in BCG-unresponsive NMIBC","bullets":["71% complete response rate at any time (15/21 pts); 67% at 3 months; 47% at 6 months (8/17) in BCG-unresponsive NMIBC with Cis.","No drug-related discontinuations; TRAEs mostly Grade 1/2; two Grade 3 (peripheral edema, urosepsis); no Grade 4/5.","Median age 74; median 11 prior BCG doses; tumor stages: T1+Cis (14.3%), Ta+Cis (14.3%), Cis only (71.4%).","Company plans protocol refinements; conference call at 8:00 AM ET on Sept 26."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-109463","json":"https://secwatch.observer/filing/0000950170-24-109463.json","markdown":"https://secwatch.observer/filing/0000950170-24-109463.md","text":"https://secwatch.observer/filing/0000950170-24-109463.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1980845/000095017024109463/0000950170-24-109463-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1980845/000095017024109463/engn-20240926.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T01:41:41.766244+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"}