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or View more offersArticle contentData update on key regulatory endpoints, complete response (CR) at any time and maturing durability, as well as landmark CR rates from LEGEND’s pivotal cohort planned for 4Q 2026Article contentWe apologize, but this video has failed to load.Try refreshing your browser, or
tap here to see other videos from our team.Article contentPre-Biologics License Application (BLA) meeting with the FDA on track for 4Q 2026Article contentInitiation of BLA submission for detalimogene planned for 4Q 2026Article contentDArticle contentetalimogeneArticle content plus surfactant cohort safety run-in successfully cleared; Webinar on surfactant plus detalimogene preclinical data and cohort enrollment guidance planned for October 15, 2026Article content
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Article contentWell-capitalized with $266 million in cash, cash equivalents, and marketable securities, supporting continued capital discipline and execution toward BLA filing and precommercial readinessArticle contentArticle content
BOSTON & MONTREAL — enGene Therapeutics Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced its financial results for the third quarter ended July 31, 2026, and provided clinical and corporate updates.
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“As we move through the second half of 2026, our focus is on maturing regulatory endpoints data from LEGEND’s pivotal cohort and our planned engagement with the FDA regarding a BLA filing for detalimogene,” said Ron Cooper, President and Chief Executive Officer, enGene. “We believe the clinical profile observed to date, together with detalimogene’s potential best-in-class tolerability and straightforward, office-based administration, supports it becoming an important treatment option for urologists and their patients with BCG-unresponsive NMIBC.”
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“We are pleased to have cleared the surfactant safety run-in period and are encouraged by the progress of the cohort, which is designed to explore whether we can further enhance efficacy and durability while preserving tolerability and the practical attributes that we believe differentiate detalimogene,” added Mr. Cooper. “With a strong balance sheet, we remain focused on disciplined capital allocation to advance the program toward BLA submission and prepare for commercialization.”
Article contentRecent Clinical and Corporate UpdatesArticle contentDetalimogene without Surfactant Pivotal Cohort 1: Article content
Detalimogene previously reported an interim 54% complete response (CR) rate at any time and a low rate of progression to muscle-invasive disease (3.2%) in LEGEND’s pivotal Cohort 1, which is evaluating detalimogene without surfactant in patients with high-risk (HR), Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). enGene expects to report updated data on key primary and secondary regulatory endpoints (CR at any time and Duration of Response (DOR) ≥ 12 months), as well as additional durability datapoints, from Cohort 1 and conduct a pre-BLA meeting with the FDA in 4Q 2026 to discuss its planned initiation of a BLA filing before yearend.
Article contentDetalimogene plus Surfactant Key Opinion Leader (KOL) Webinar:Article content
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The Company is currently enrolling high-risk, BCG-unresponsive NMIBC patients with CIS in an additional LEGEND cohort incorporating a brief surfactant bladder rinse with an FDA-approved surfactant solution (generic name: polidocanol). Surfactants have been shown to enhance the efficacy of other intravesical gene therapies for NMIBC and have subsequently been incorporated into their clinical development. In murine models tested by the Company, pretreatment with polidocanol demonstrated a 10-fold increase in mean IL-12 expression and was able to boost efficacy of a subtherapeutic dose of detalimogene. Findings were validated in a large mammal model where a brief surfactant rinse significantly increased the distribution of detalimogene nanoparticles throughout the bladder and IL-12 expression by over nine-fold. Preclinical data indicates that use of a surfactant bladder rinse not only raises the peak of transgene expression but makes transfection consistent across the bladder surface. In a disease that recurs multifocally, transfection coverage may matter as much as amplitude.
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On October 15, 2026, at 10:00 a.m. ET, the Company will host a webinar to provide greater detail on the preclinical data supporting the incorporation of its surfactant bladder rinse into clinical development. In addition, the Company will be joined by two KOLs from Colorado Urology, David Cahn, MD, and Suzanne Merrill, MD, FACS, to review clinical case studies and discuss various treatment considerations.
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Please click here to register for the event.
Article contentEmerging NMIBC Market Insights KOL Webinar:Article content
On August 11, 2026, the Company hosted a virtual KOL event featuring Neal Shore, MD, FACS, Medical Director for START-Carolinas Research, who joined management to discuss the evolving non-muscle invasive bladder cancer (NMIBC) treatment landscape. As a part of its broader pre-commercial preparation efforts, the Company shared highlights from its ongoing market research, including the future treatment paradigm where avoidance of radical cystectomy by sequencing multiple lines of therapy will become the norm, the prevalent population will continue to grow as a result of increased sequencing, and a new market price point has been established by recently launched products.
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Dr. Shore emphasized the importance of a product profile that could address the various needs of community urology practices, including practice workflow constraints, while also providing a well-tolerated and effective therapy for patients. A replay of the webinar can be accessed here.