BLA filing hinges on whether 25% 12-month durability satisfies FDA after a 50% workforce cut reset expectations

enGene Therapeutics is a clinical-stage company developing a gene therapy for patients with bladder cancer that has not responded to standard BCG treatment and is not yet approved.

DetalimogeneI is an intravesical gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer, a setting where patients face radical cystectomy if current options fail. A 54% any-time complete response rate in 125 patients supported a planned BLA filing, but a 25% Kaplan-Meier 12-month CR estimate, lower response rates in the most recent patient cohort, and a roughly 50% workforce reduction have created genuine uncertainty about approvability on single-arm data. The central question is whether FDA accepts this durability profile for accelerated approval, given that ImmunityBio's ANKTIVA already holds approval in the same BCG-unresponsive CIS population with a competing mechanism.