08:09 AM EST, 11/11/2025 (MT Newswires) -- EnGene ( ENGN ) said Tuesday that additional preliminary data from the pivotal cohort of its mid-stage trial of detalimogene voraplasmid showed an improved complete response rate of 62% in six months for patients with high-risk, Bacillus Calmette-Guerin unresponsive non-muscle invasive bladder cancer patients with carcinoma in situ.

The data also showed low rates of treatment-related adverse events and dose interruptions, the company said.

After an agreement with the US Food and Drug Administration on a statistical analysis plan and the accumulation of 12-month complete response data points, the company said it expects to provide a data update on the pivotal cohort in H2 of next year.

The company said it still targets to file a biologics license application in H2 of next year, with potential regulatory approval in 2027.