Core Viewpoint - enGene Holdings Inc. is experiencing a significant increase in stock price following the release of preliminary data from its Phase 2 LEGEND trial for detalimogene voraplasmid in high-risk bladder cancer patients [2][6]. Group 1: Trial Data and Results - The LEGEND trial included 99 patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) [2]. - Preliminary analysis showed a 63% complete response (CR) rate at any time for 62 patients, with a 56% CR rate at 3 months and a 62% CR rate at 6 months for 37 patients [8]. - The company exceeded its enrollment target by 25%, completing enrollment of 125 patients in the pivotal cohort [3][4]. Group 2: Future Plans and Expectations - The company plans to file a Biologics License Application (BLA) in the second half of 2026, with potential FDA approval expected in 2027 [5][6]. - enGene anticipates providing a data update on the LEGEND trial's pivotal cohort in the second half of 2026 [5]. Group 3: Market Performance - enGene Holdings shares rose by 64.73% to $9.90, reaching a new 52-week high [6].
EnGene Encouraged By Promising Response Rates In Bladder Cancer Trial