enGene Hits 62% CR in 125-Patient LEGEND Trial, Plans BLA by End-2026
enGene’s LEGEND pivotal cohort reached 125 NMIBC patients, with post-amendment data from 62 of 94 showing a 62% six-month complete response and under 1% discontinuation. The company targets a second-half 2026 LEGEND update, a BLA submission by year-end 2026 and potential commercial launch in 2027, with cash runway into mid-2028.
1. Regulatory and Clinical Milestones
enGene’s leadership outlined plans to provide a pivotal LEGEND program update in the second half of 2026, submit a biologics license application by year-end 2026 and target commercial launch of its lead NMIBC therapy in 2027.
2. LEGEND Pivotal Study Results
The LEGEND pivotal cohort completed enrollment at 125 patients, with 62 post-amendment participants showing a six-month complete response rate of 62% and less than 1% discontinuations, predominantly Grade 1–2 adverse events.
3. Non-Viral EDV Platform Advantages
enGene’s non-viral EDV platform enables repeat dosing without immunogenicity, simple freezer or refrigerator storage, and competitive manufacturing using readily available ingredients, supported by an FDA CDRP designation.
4. Financial Runway and Outlook
The company reports cash runway into the second half of 2028, underpinning ongoing development, scale production toward FDA validation batches and exploration of combination strategies.