enGene (ENGN) soars after detailing 62% 6‑month complete response in pivotal bladder‑cancer trial; BLA still targeted for 2H 2026
enGene Holdings Inc. (NASDAQ: ENGN) reported fresh preliminary data this morning from the pivotal cohort of its Phase 2 LEGEND trial of detalimogene voraplasmid (formerly EG‑70) in high‑risk, BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) with CIS. The readout shows a 62% complete response (CR) at 6 months (n=37), 56% at 3 months (n=62) and 63% CR at any time (n=62) under the trial’s amended protocol—plus a favorable safety profile (42% treatment‑related adverse events; 1.6% dose interruptions; 0.8% discontinuations). The company completed enrollment of 125 patients in the pivotal cohort, above target, and will refine its analysis with FDA input on