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중대신청 제출
enGene, detalimogene에 대한 BLA 제출을 2026년 하반기에 계획
The company announced plans to hold a pre-BLA meeting with the FDA and initiate BLA submission for detalimogene in the second half of 2026. Potential FDA approval is guided for 2027. The pivotal LEGEND cohort (Cohort 1) in BCG-unresponsive NMIBC with CIS is intended to support the filing.
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EX-99.1 2 engn-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 enGene Focuses Board to Support Planned Upcoming Regulatory and Commercial Milestones Michael Heffernan assumes the role of Chairman of the Board Dr. Richard Glickman to step down Pre-Biologics License Application (BLA) meeting with the FDA planned for 2H 2026 Initiation of BLA submission for detalimogene planned for 2H 2026 Potential FDA approval of detalimogene in 2027 BOSTON & MONTREAL, July 16, 2026 – enGene Therapeutics Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced changes to its Board of Directors as it plans for potential regulatory milestones and to support commercial readiness for detalimogene voraplasmid (“detalimogene”) if approved. Detalimogene is b