Engene (EnGene/Engene Holdings) released additional preliminary results from its pivotal Legend Phase II cohort testing detalimogene voraplasmid in high‑risk, BCG‑unresponsive non‑muscle invasive bladder cancer. The company said outcomes continue to support a planned BLA filing in 2026 and disclosed trial amendments that strengthened the pivotal cohort. Investors reacted strongly: shares surged after the data release. Company statements and financial reports indicate Engene plans a regulatory filing next year if confirmatory data hold. The gene therapy uses a nonviral delivery platform; sponsors highlighted the safety profile and regulatory path as key differentiators versus viral approaches.