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Investing.com -- enGene Holdings Inc. (NASDAQ:ENGN) stock rose 5% after the clinical-stage genetic medicines company reported improved complete response rates for its bladder cancer treatment detalimogene voraplasmid.
The company announced that detalimogene demonstrated a 62% complete response rate at 6 months in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. This data comes from the pivotal cohort of its ongoing Phase 2 LEGEND trial, which has now completed enrollment with 125 patients, exceeding its target.
The preliminary analysis included 62 patients at 3 months and 37 patients at 6 months, all evaluated under the trial’s amended protocol designed to better align with standard care guidelines. The data showed a 63% complete response rate at any time, 56% at 3 months, and 62% at 6 months.
Notably, the treatment demonstrated a favorable safety profile with only 42% of patients experiencing treatment-related adverse events. Dose interruptions occurred in just 1.6% of patients, while discontinuations due to adverse events were limited to 0.8%.
Following discussions with the FDA, enGene has updated the primary endpoint for the LEGEND trial’s pivotal cohort to complete response rate at any time, with duration of response becoming the key secondary endpoint.
The company plans to file a Biologics License Application in the second half of 2026, with potential FDA approval in 2027. The emerging clinical profile supports potential first-line use in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
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