The company is now looking forward to submitting an application for approval of the cancer therapy to the U.S. Food and Drug Administration in the second half of 2026.
Shares of enGene Holdings Inc. (ENGN) jumped 53% in the pre-market session on Tuesday after the company said that its Detalimogene voraplasmid demonstrated a complete response rate of 62% at six months in a study.
The study was evaluating the experimental drug in certain high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) patients.
Complete response rate is the percentage of patients whose cancer disappears completely after treatment, a measure often used in cancer research to evaluate a therapy’s effectiveness
The company is now looking forward to submitting an application for approval of the cancer therapy to the U.S. Food and Drug Administration in the second half of 2026.
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