enGene to Initiate a BLA Submission for Detalimogene by Year End and Reports New Data from LEGEND Trial Pivotal Cohort 1 in BCG-Unresponsive NMIBC

Ashish M. Kamat, Professor of Urologic Oncology at The University of Texas MD Anderson Cancer Center and Primary Investigator of the LEGEND trial

“The updated LEGEND data are encouraging, demonstrating clinically meaningful antitumor activity with a favorable tolerability profile. Combined with its straightforward administration and handling requirements, detalimogene has the potential to become a valuable addition to our bladder-preserving treatment options, particularly in community urology practices where ease of administration and practical considerations can influence treatment selection.”

Ron Cooper, President and Chief Executive Officer of enGene

“The updated results from Cohort 1 demonstrate encouraging improvements across all key efficacy measures as the data have matured, bringing detalimogene’s efficacy profile to date within range of approved products for this indication.”

Ron Cooper, President and Chief Executive Officer of enGene

“Importantly, our recent interactions with the FDA provide a clear path to initiate a BLA submission before year-end 2026, representing a significant step toward bringing detalimogene to patients, with potential approval in 2027.”

Ron Cooper, President and Chief Executive Officer of enGene

“In parallel, we are preparing for commercialization, with a focus on positioning detalimogene for broad adoption across community urology practices, where more than 75% of high-risk, BCG-unresponsive NMIBC patients receive care. We believe detalimogene’s differentiated ease of use and handling could facilitate integration into existing treatment settings, helping expand access to a new bladder-preserving treatment option for patients.”