detalimogene voraplasmid ("detalimogene") — Clinical data readout
in 4Q 2026
Detalimogene previously reported an interim 54% complete response (CR) rate at any time and a low rate of progression to muscle-invasive disease (3.2%) in LEGEND's pivotal Cohort 1, which is evaluating detalimogene without surfactant in patients with high-risk (HR), Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). enGene expects to report updated data on key primary and secondary regulatory endpoints (CR at any time and Duration of Response (DOR) ≥ 12 months), as well as additional durability datapoints, from Cohort 1 and conduct a pre-BLA meeting with the FDA in 4Q 2026 to discuss its planned initiation of a BLA filing before yearend.Source filing