enGene’s Phase II LEGEND trial update for detalimogene in high-risk BCG-unresponsive nonmuscle invasive bladder cancer triggered a sharp stock drop, with investors reacting to declining complete response rates. The data cut off April 21 showed 54% complete response at any time among 67 evaluable patients in Cohort 1, with the six-month CR rate falling to 43%. The company said durability outcomes to date are preliminary and that longer-term data is expected later this year, while also indicating ongoing discussions with the FDA about statistical analysis plans and potential BLA filing. For the NMIBC competitive environment, the report increases pressure on durability and endpoint maturity, especially as treatment options continue to diversify around BCG-refractory and CIS±papillary disease.