FDA approves UroGen Pharma's ZUSDURI (mitomycin) for recurrent LG-IR-NMIBC

UroGen Pharma Ltd.

FDA approved ZUSDURI (mitomycin) for adults with recurrent low-grade intermediate-risk NMIBC on June 12, 2025.
Phase 3 ENVISION trial: 78% achieved complete response at 3 months; 79% of those maintained at 12 months.
Expected commercial availability in the U.S. on or around July 1, 2025.
Common adverse reactions include increased creatinine, dysuria, hematuria; serious reactions in 12% of patients.
Post-marketing commitment: ongoing ENVISION trial to further characterize clinical benefit; annual duration of response updates.

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