enGene Therapeutics Inc. — November 2026 Earnings Summary

enGene Therapeutics is developing detalimogene voraplasmid, a non-viral gene therapy for high-risk non-muscle invasive bladder cancer (NMIBC) that activates the RIG-I pathway to induce localized immune responses. In the pivotal LEGEND study cohort, detalimogene demonstrated a 56% complete response rate at any time with a favorable safety profile, showing lower rates of treatment discontinuation compared to existing therapies. The company plans to initiate a Biologics License Application filing in the fourth quarter of 2026, with potential approval expected in 2027. Additionally, ongoing research into a surfactant bladder rinse aims to enhance drug transfection, potentially improving efficacy and reducing treatment dwell time from 60 to 30 minutes.