08:33 AM EDT, 06/25/2025 (MT Newswires) -- enGene Holdings (ENGN) said Wednesday that the US Food and Drug Administration has granted Regenerative Medicine Advanced Therapy designation to the company's lead investigational therapy, detalimogene voraplasmid, for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.

enGene said the designation is designed to expedite the development of promising regenerative medicine therapies for serious conditions with unmet medical needs.

The designation was granted based on early data from enGene's ongoing pivotal study, which showed strong clinical activity and a favorable safety profile in patients.

Share of the company were up 11% in recent Wednesday's premarket activity.