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On May 16, 2025, the FDA stated: “Given that ENVISION lacked a concurrent control arm, the primary endpoints of complete response (CR) and duration of response (DOR) are difficult to interpret. While CR indicates drug activity of UGN-102, it is unclear whether the observed DOR can be attributed to the investigational product or instead reflects the natural history of the disease.”
Following this news, the price of the Company’s stock dropped on the same day.