enGene (ENGN) soars after detailing 62% 6‑month complete response in pivotal bladder‑cancer trial; BLA still targeted for 2H 2026

enGene Holdings Inc. reported fresh preliminary data this morning from the pivotal cohort of its Phase 2 LEGEND trial of detalimogene voraplasmid in high‑risk, BCG‑unresponsive non‑muscle invasive bladder cancer with CIS. The readout shows a 62% complete response at 6 months, 56% at 3 months and 63% CR at any time under the trial’s amended protocol—plus a favorable safety profile. The company completed enrollment of 125 patients in the pivotal cohort, above target, and will refine its analysis with FDA input on the statistical analysis plan. Business Wire