enGene Holdings Inc. (NASDAQ:ENGN) shares climbed 5% on Tuesday after the clinical-stage genetic medicines company reported promising new data showing improved complete response rates for its investigational bladder cancer treatment detalimogene voraplasmid.

The company said that detalimogene achieved a 62% complete response rate at six months in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). The findings come from the pivotal cohort of its ongoing Phase 2 LEGEND trial, which has now fully enrolled 125 patients, surpassing its initial target.

A preliminary analysis included 62 patients evaluated at three months and 37 patients at six months, all assessed under the trial’s amended protocol to better align with current standard-of-care practices. According to the results, detalimogene achieved a 63% complete response rate at any time, 56% at three months, and 62% at six months.

The treatment also displayed a favorable safety profile, with only 42% of patients reporting treatment-related adverse events. Dose interruptions occurred in just 1.6% of patients, while treatment discontinuations due to side effects were limited to 0.8%.

Following consultations with the U.S. Food and Drug Administration (FDA), enGene said it has updated the primary endpoint of the LEGEND trial’s pivotal cohort to focus on complete response rate at any time, with duration of response designated as the key secondary endpoint.

The company intends to submit a Biologics License Application (BLA) to the FDA in the second half of 2026, aiming for potential approval in 2027. enGene said the emerging data support detalimogene’s potential as a first-line therapy for patients with high-risk, BCG-unresponsive NMIBC with CIS.

enGene Holdings stock price

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