secwatch.observer — SEC 8-K summary
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Issuer:     enGene Therapeutics Inc. (ENGN)
CIK:        0001980845
Form:       8-K
Filed at:   2026-05-07T23:59:59+00:00
Accession:  0001193125-26-210316
Event type: other_material
Sentiment:  neutral
Materiality: 0.80
Item codes: 5.02, 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

enGene reports 54% CR at any time in Phase 2 LEGEND trial; 43% CR at 6 months
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1980845/000119312526210316/0001193125-26-210316-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1980845/000119312526210316/d335486d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-210316

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer