BOSTON & MONTREAL — enGene said it will change its corporate name to enGene Therapeutics Inc., reflecting its transition toward becoming a commercial-stage company ahead of a potential product approval in 2027.
The name change, effective April 8, comes as the clinical-stage biotechnology company advances detalimogene voraplasmid, an investigational gene therapy for high-risk non-muscle invasive bladder cancer (NMIBC). The company said it plans to submit a Biologics License Application for the therapy in the second half of 2026.
“We’re entering an important next phase for enGene as we prepare for potential approval of detalimogene in 2027,” said Ron Cooper, president and chief executive officer. “Our new name reflects our progress — and the opportunity to bring detalimogene to patients and the practices that care for them, where more options are still needed.”
The company’s shares will continue trading on the Nasdaq Capital Market under the ticker symbol ENGN, with warrants trading under ENGNW. enGene said the name change will not affect shareholder rights, though new CUSIP and ISIN identifiers will take effect.
Detalimogene is a non-viral gene therapy designed to be delivered directly into the bladder to trigger a localized immune response against tumors. The therapy is being evaluated in the ongoing LEGEND trial across multiple cohorts of patients with high-risk NMIBC, including those who no longer respond to Bacillus Calmette-Guérin, the current standard of care.
NMIBC accounts for roughly 75% to 80% of newly diagnosed bladder cancer cases. Patients with high-risk disease who do not respond to existing therapies face recurrence rates as high as 50% to 70% and may require bladder removal as a last-resort treatment.
The therapy has received Regenerative Medicine Advanced Therapy and Fast Track designations from the U.S. Food and Drug Administration, signaling its potential to address significant unmet medical needs. It is also part of the agency’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot program, which is designed to support therapies with accelerated development timelines.
