{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-210316","form_type":"8-K","ticker":"ENGN","cik":"0001980845","company_name":"enGene Therapeutics Inc.","filed_at":"2026-05-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:33.349144+00:00","generated_at":"2026-05-14T22:05:26.182760+00:00","sec_items":["5.02","7.01","8.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"enGene reports 54% CR at any time in Phase 2 LEGEND trial; 43% CR at 6 months","bullets":["54% complete response (CR) at any time (67/124) and 43% CR at 6 months (52/121) in BCG-unresponsive NMIBC with CIS.","Progression to muscle-invasive disease was low at 3.2%; Kaplan-Meier 12-month CR rate estimate is 25%.","Safety profile favorable: 55% treatment-related adverse events, mostly Grade 1-2; 2.4% led to discontinuation.","Company plans continued FDA engagement for BLA; data to be presented at AUA on May 15; update expected H2 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-210316","json":"https://secwatch.observer/filing/0001193125-26-210316.json","markdown":"https://secwatch.observer/filing/0001193125-26-210316.md","text":"https://secwatch.observer/filing/0001193125-26-210316.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1980845/000119312526210316/0001193125-26-210316-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1980845/000119312526210316/d335486d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-14T22:05:26.182760+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"}