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

enGene Therapeutics Inc.

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.

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