ENGENE THERAPEUTICS INC.

enGene Therapeutics released results for the quarter ended July 31, 2026, reporting earnings per share (EPS) of -$0.47. A year earlier the company had reported an EPS of -$0.57. » Mere på finanzen.net

enGene reported progress on the non-viral gene therapy detalimogene voraplasmid for BCG-refractory, non–muscle-invasive bladder cancer at the Wells Fargo conference. The pivotal LEGEND cohort includes 125 patients; interim results showed a complete response rate of 54% at any time with a discontinuation rate of 2.4%. The company reports cash of $266 million, considers funding for the next development and approval phases secured, and names manufacturing and regulatory implementation as key challenges; BLA submission is planned for the end of 2024 with expected approval in 2025. A surfactant cohort using polidocanol as a potential add-on is also being advanced. » Mere på de.investing.com

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. » Mere på de.investing.com