enGene names new board chairman ahead of planned BLA filing

enGene Therapeutics Inc. (Nasdaq: ENGN) announced changes to its board of directors, with Michael Heffernan assuming the role of chairman and Dr. Richard Glickman stepping down after more than 14 years in the position.

Heffernan has served on enGene's board since July 2025. He is the founder of Collegium Pharmaceutical and has previously held leadership roles at Onset Dermatologics, Clinical Studies Ltd., and Eli Lilly and Company. He currently serves as chairman at NMD Pharma, Avalo Therapeutics, and AAVantgarde Bio, and as a board member at Biohaven, Trevi Therapeutics, and K36 Therapeutics.

The board changes come as enGene plans a pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration and the initiation of a BLA submission for its lead drug candidate, detalimogene voraplasmid, both targeted for the second half of 2026. The company has stated potential FDA approval could follow in 2027.

Detalimogene is an investigational non-viral gene therapy being evaluated in the Phase 2 LEGEND trial for patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. The trial's pivotal cohort enrolls 125 patients and is designed to support the planned BLA filing. The drug has received Regenerative Medicine Advanced Therapy and Fast Track designations from the FDA.

"With a clinical-stage asset approaching both a key pivotal readout and planned BLA filing in the second half of this year, a potential approval in 2027 and in a strong capital position, enGene is well positioned for a period of meaningful growth," Heffernan said in a statement.

Ron Cooper, enGene's president and chief executive officer, noted that Glickman played a role in guiding the company's transition from a research organization to a late clinical-stage company. Glickman continues to serve on the boards of several other biotechnology companies, according to the press release.

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