On April 7, 2026 enGene Therapeutics Inc. (formerly, enGene Holdings Inc.) (Nasdaq: ENGN, "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported that it will change its corporate name to "enGene Therapeutics Inc." effective April 8, 2026. The Company elected to change its corporate name to reflect the near-term transition to a commercial organization with the potential approval of detalimogene voraplasmid in 2027. enGene’s ongoing LEGEND trial is investigating detalimogene across several cohorts of high-risk non-muscle invasive bladder cancer (NMIBC), including a pivotal cohort in BCG-unresponsive NMIBC with carcinoma in situ (CIS).
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"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, enGene. "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 common shares (the "Common Shares") will continue to trade on the Nasdaq Capital Market (the "Nasdaq") under the symbol "ENGN", and the Company’s listed common share purchase warrants (the "Warrants") will continue to trade on the Nasdaq under the symbol "ENGNW".
The corporate name change does not affect the rights of security holders, and no further action is required by security holders with respect to the change. As of the effective date, the CUSIP numbers and ISINs of the Common Shares and Warrants will change. The new CUSIP number for the Common Shares is 29286X101 and the new ISIN number is CA29286X1015. The new CUSIP number for the Warrants is 29286X119 and the new ISIN number is CA29286X1197.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
Non-muscle invasive bladder cancer (NMIBC) is a disease that poses a significant burden on both patients and clinics and has a massive economic impact on our healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall. NMIBC can present as papillary outgrowths from the bladder wall, which are typically resected, or as carcinoma in situ (CIS), which consists of flat, multifocal lesions that cannot be resected. The two forms can also co-occur. About 75-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence (50-70%) and are potentially subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.
About Detalimogene Voraplasmid
Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.
Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.
Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. The RMAT program is intended to expedite the development and review of regenerative medicine therapies for serious or life-threatening conditions, where preliminary clinical evidence suggests potential to address unmet medical needs. Similarly, Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Detalimogene has also been selected to participate in the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program. The FDA created the CDRP Program to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy.
About the LEGEND Trial
Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (Cohort 1) consists of 125 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes three additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); and BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3). The LEGEND trial is actively enrolling patients with sites participating in the USA, Canada, Europe, and the Asia-Pacific region.
(Press release, enGene, APR 7, 2026, View Source [SID1234664220])