enGene Therapeutics reports Q3 2026 earnings and clinical updates

enGene Therapeutics Inc. has announced its third quarter 2026 financial results, reporting earnings per share of ($0.47), which met consensus estimates. The clinical-stage genetic medicines company reported a strong balance sheet with $266 million in cash, cash equivalents, and marketable securities to support its upcoming regulatory milestones.

On the clinical front, the company is preparing for a Pre-Biologics License Application (BLA) meeting with the FDA in the fourth quarter of 2026. This is part of the planned BLA submission for detalimogene, which is intended for patients with BCG-unresponsive NMIBC. enGene also reported that the detalimogene plus surfactant cohort safety run-in was successfully cleared.

CEO Ron Cooper stated that the company is focused on maturing regulatory endpoints data from the LEGEND pivotal cohort and moving toward precommercial readiness.