enGene advances bladder cancer therapy program
- enGene Therapeutics reported progress toward regulatory filings for detalimogene, a gene therapy candidate for BCG-unresponsive non-muscle invasive bladder cancer.
- The company plans to hold a pre-BLA meeting with the FDA in the fourth quarter of 2026 and begin BLA submission activities during the same period.
- enGene reported $266 million in cash, cash equivalents, and marketable securities, supporting continued development and commercial preparation.
enGene Therapeutics (NASDAQ:ENGN) reported regulatory and clinical progress for detalimogene, including plans for a U.S. FDA pre-BLA meeting and initiation of a Biologics License Application submission in the fourth quarter of 2026.
The company said updated data from the LEGEND pivotal cohort will include complete response rates, response durability, and additional regulatory endpoints for patients with BCG-unresponsive non-muscle invasive bladder cancer.
enGene previously reported a 54% complete response rate at any time and a 3.2% rate of progression to muscle-invasive disease in LEGEND Cohort 1, which evaluates detalimogene without surfactant in high-risk patients with carcinoma in situ.
The company said its detalimogene plus surfactant cohort cleared a safety run-in period, with the program evaluating whether a surfactant bladder rinse can improve treatment distribution and durability while maintaining tolerability.
enGene Therapeutics develops non-viral genetic medicines, with detalimogene being evaluated as an intravesical gene therapy for patients with BCG-unresponsive non-muscle invasive bladder cancer.
