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ENGN gene therapy nears FDA submission for NMIBC

Detalimogene voraplasmid is advancing toward FDA submission. Pivotal data are set to mature by year-end, with interim efficacy and tolerability described as strong, positioning it for community urology adoption.

ENGN

Detalimogene voraplasmid is advancing toward FDA submission, with pivotal data expected to mature by year-end and interim efficacy and tolerability still supporting the program. The product is being positioned for broad adoption in community urology practices, with its ease of use and robust safety profile cited as differentiating features. A surfactant co...