Investing.com -- enGene Holdings Inc (NASDAQ:ENGN) stock rose 2% on Tuesday after the FDA selected its bladder cancer therapy for a specialized manufacturing readiness program.
The clinical-stage genetic medicines company announced that its non-viral gene therapy, detalimogene voraplasmid, has been chosen to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. The therapy is being developed for patients with high-risk, non-muscle invasive bladder cancer.
The CDRP Program, which selects only nine companies annually, is designed to support manufacturing development for therapies with compressed clinical development timeframes. It allows for earlier and more structured engagement between companies and the FDA on manufacturing strategies.
"Manufacturing readiness in drug development is often underappreciated. We have already scaled detalimogene manufacturing to commercial-level, and CDRP is expected to help ensure CMC readiness for filing and commercialization," said Ron Cooper, President and Chief Executive Officer of enGene.
The selection comes shortly after enGene reported positive preliminary results from its LEGEND trial’s pivotal cohort. The trial showed an improved complete response rate of 62% at six months in patients with high-risk, BCG-unresponsive bladder cancer with carcinoma in situ. Safety data from 125 patients demonstrated a favorable tolerability profile, with low rates of treatment-related adverse events.
Detalimogene has already received Regenerative Medicine Advanced Therapy and Fast Track designations from the FDA. The company plans to submit a Biologics License Application for the therapy in the second half of 2026.
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