enGene Holdings Says FDA Selects Detalimogene Voraplasmid To Participate In Chemistry, Manufacturing, And Controls Development And Readiness Pilot Program

enGene one of nine companies awarded CDRP per year

Program aims to support CMC development of products with expedited clinical development timeframes and provide patients with earlier access to these products

Detalimogene has already been manufactured at commercial scale, and CDRP provides additional FDA CMC interactions ahead of a potential BLA submission in 2H 2026

enGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, today announced that the U.S. Food and Drug Administration (FDA) has selected detalimogene voraplasmid (also known as detalimogene and previously EG-70) to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program.Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC).