ENGENE THERAPEUTICS INC.

enGene released interim results from the phase‑2 LEGEND study of detalimogen voraplasmid in 125 patients with high‑risk non‑muscle‑invasive bladder cancer who are unresponsive to BCG. The complete response rate was 54% at any time and 43% at six months; the progression rate to muscle‑invasive or advanced disease was 3.2% with a median duration of response of 37.3 weeks. Treatment was generally well tolerated (55% treatment‑related adverse events, mostly grade 1–2; six patients with grade ≥3; 2.4% discontinuations). enGene has completed validation lots for FDA manufacturing, submitted a statistical analysis plan and plans to consider a potential regulatory filing decision in the second half of 2026; the data will be presented on May 15, 2026 at the AUA. » More on de.investing.com