ENGENE THERAPEUTICS INC.

enGene announced at the Morgan Stanley Healthcare Conference that the non-viral gene therapy Detalimogen, with a complete response rate of 54% in the approval-relevant cohort, is on track for a BLA submission. The company has $266 million in cash and expects the pivotal 12-month durability data in H2 2026, a pre-BLA meeting still in 2026, and possible approval in 2027. enGene highlights advantages in manufacturing, storage and handling, is targeting office-based urologists as the primary users, and sees substantial market potential in BCG-refractory cases. » More on de.investing.com

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. » More on 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. » More on de.investing.com