enGene Holdings Inc. (ENGN) Wednesday said that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead drug candidate, detalimogene for the treatment of high-risk, non-muscle invasive bladder cancer.
This designation provides enGene with several advantages including early and frequent engagement with the FDA, potential for rolling review and priority review, and other benefits like Fast Track and Breakthrough Therapy designations.
The designation was based on previously announced preliminary results from the ongoing pivotal Phase 2 LEGEND study, which showed compelling clinical activity and a generally favorable tolerability profile in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).
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May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.