UroGen's ZUSDURI Approved, Faces Lawsuit After Surge

UroGen Pharma received FDA approval for ZUSDURI™ (mitomycin), the first therapy specifically for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The approval followed a negative 5-4 vote from the Oncologic Drugs Advisory Committee, which cited concerns about the lack of a randomized control group and short follow-up in the pivotal Phase 3 ENVISION trial. The trial reported a 78-79% complete response rate at three months and nearly 80% of responders were cancer-free after a year. ZUSDURI is administered via catheter as an outpatient procedure, offering a non-surgical option for patients who often undergo repeated surgeries. UroGen has committed to ongoing post-marketing studies and annual updates to the FDA. Following the approval, UroGen's stock surged by over 50%, but the company now faces a class-action lawsuit over allegedly misleading statements made during the approval process.