enGene reports Q3 2026 results, keeps 4Q BLA-related timelines for detalimogene
The company said it remains on track for a pre-BLA meeting and to start a BLA submission for detalimogene in the fourth quarter of 2026, with $266 million in cash.
enGene Therapeutics reported financial results for the third quarter ended July 31, 2026, on September 8, 2026, and provided clinical and corporate updates.
In LEGEND's pivotal Cohort 1, evaluating detalimogene without surfactant in high-risk, BCG-unresponsive NMIBC patients with CIS, the company previously reported an interim 54% complete response rate at any time and a low rate of progression to muscle-invasive disease of 3.2%.1 enGene said it expects to report updated data on key primary and secondary regulatory endpoints, including CR at any time and Duration of Response of 12 months or more, plus additional durability data, and to conduct a pre-BLA meeting with the FDA in the fourth quarter of 2026 to discuss its planned initiation of a BLA filing before year end.1
The company is also enrolling high-risk, BCG-unresponsive NMIBC patients with CIS in an additional LEGEND cohort that incorporates a brief surfactant bladder rinse using the FDA-approved surfactant polidocanol.1 enGene said the safety run-in period for that surfactant cohort has been cleared1 and plans a webinar on October 15, 2026, to review preclinical data and case studies with two outside physicians.
On leadership, Michael Heffernan, a board member since July 2025, assumed the role of Chairman in July 2026, succeeding Dr. Richard Glickman, who had served as Chairman for over 14 years.1
Financially, cash, cash equivalents and marketable securities were $266.3 million as of July 31, 2026, providing significant operational flexibility.1 Total operating expenses were $34.0 million for the three months ended July 31, 2026, compared to $29.9 million a year earlier.1 Net loss attributable to common shareholders was approximately $32.5 million, or $0.47 per share, versus about $29.0 million, or $0.57 per share, in the prior-year quarter.1
Looking ahead, the company listed a data update on key regulatory endpoints and landmark CR rates from LEGEND's pivotal cohort planned for the fourth quarter of 2026, a pre-BLA meeting with the FDA in the same quarter, initiation of the BLA filing in the fourth quarter, and a potential FDA approval decision in 2027.1
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