enGene Holdings Inc. (NASDAQ:ENGN) traded 2% higher on Tuesday after the company revealed that the FDA has selected its bladder cancer therapy for a specialized program aimed at accelerating manufacturing readiness.
The gene-medicine developer announced that its lead non-viral gene therapy candidate, detalimogene voraplasmid, has been accepted into the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. The therapy targets patients with high-risk, non-muscle invasive bladder cancer.
The CDRP initiative—limited to just nine participants per year—is designed to help companies with products advancing on compressed clinical timelines, giving them structured, early-stage collaboration with the FDA on manufacturing and scale-up plans.
“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 FDA’s decision follows encouraging preliminary data from the pivotal cohort of enGene’s LEGEND trial, which reported a six-month complete response rate of 62% in patients with high-risk, BCG-unresponsive bladder cancer with carcinoma in situ. Among 125 treated patients, the therapy also demonstrated a favorable safety profile with low rates of treatment-related side effects.
Detalimogene has previously been granted both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations. enGene said it plans to submit a Biologics License Application in the back half of 2026.