Business
FDA Grants RMAT Designation for enGene’s Detalimogene, Enabling Potential for Expedited Review in High-Risk, Non-Muscle Invasive Bladder Cancer
BOSTON & MONTREAL, June 25, 2025--enGene Holdings Inc. (Nasdaq: ENGN, or "enGene" or the "Company"), a clinical-stage, non-viral gene-based immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid (also known as detalimogene, and previously EG-70), the Company’s lead investigational therapy for the treatment of high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, no
About this update from Engene Therapeutics Inc.
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