enGene Therapeutics Inc. 8K

enGene Therapeutics Inc. appointed Michael Heffernan as Chairman of the Board, with former Chairman Dr. Richard Glickman stepping down, and outlined key planned FDA regulatory milestones for its lead gene therapy detalimogene voraplasmid, including a BLA submission in 2H 2026 and potential approval in 2027.

enGene Therapeutics Inc. announced changes to its Board of Directors to support upcoming regulatory and commercial milestones for its lead gene therapy detalimogene voraplasmid, with existing director Michael Heffernan assuming the role of Chairman of the Board and long-time Chairman Dr. Richard Glickman stepping down from that role. The Company highlighted its planned regulatory path for detalimogene, including a Pre-Biologics License Application (BLA) meeting with the FDA in the second half of 2026, initiation of BLA submission for detalimogene in the second half of 2026, and a potential FDA approval in 2027. Detalimogene, developed on enGene’s Dually Derivatized Oligochitosan (DDX) platform, is being evaluated in the Phase 2 LEGEND trial in high-risk non-muscle invasive bladder cancer and has received RMAT and Fast Track designations, as well as selection for the FDA’s CMC Development and Readiness Pilot program, underscoring the Company’s transition toward late-stage development and potential commercialization.

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0001193125-26-305418

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5