What is the story about?
What's Happening?
enGene Holdings Inc. has reached its target enrollment of 100 patients for the pivotal cohort of its Phase 2 LEGEND trial. The trial is evaluating detalimogene voraplasmid, a non-viral gene therapy for high-risk, non-muscle invasive bladder cancer (NMIBC). This milestone is significant for enGene as it progresses towards a Biologic License Application (BLA) submission planned for the second half of 2026.
Why It's Important?
Achieving the enrollment milestone is a critical step for enGene in developing a novel gene therapy for NMIBC, a condition with high unmet medical needs. The therapy has received Fast Track and Regenerative Medicine Advanced Therapy designations from the FDA, highlighting its potential impact on patient care. Successful trial outcomes could lead to new treatment options for patients, influencing the gene therapy landscape significantly.
What's Next?
enGene plans to provide updates from the LEGEND trial's pivotal cohort in the fourth quarter of 2025. The company is preparing for a BLA submission in 2026, which, if successful, could lead to commercialization of detalimogene voraplasmid. Continued trial progress and regulatory interactions will be key focus areas for enGene moving forward.
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