enGene: Two Major Catalysts On Deck For 2nd Half Of 2026

2026-01-27 15:17:20 ET

The last time I spoke about enGene Holdings ( ENGN ) it was with respect to a Seeking Alpha article entitled " enGene Holdings: Mid-2024 NMIBC Data Could Lead To EG-70 BLA Filing ". As an update, the company is nearing the finish line but not quite there yet. The reason why I state this is because it had gained alignment with the FDA that its pivotal Cohort 1 of the phase 2 LEGEND trial could be used as the basis to be able to file a Biologics Licensing Application [BLA] of its gene therapy detalimogene for the treatment of patients with BCG-unresponsive, high-risk non-muscle invasive bladder cancer [high-risk NMIBC] with carcinoma in situ [CIS] - with or without papillary disease. The company in November of 2025 released preliminary data from the pivotal cohort post-amendment changes showcasing that the drug was able to achieve a complete response [CR] rate of 62% at 6 months....

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