UroGen Pharma (URGN) announced preliminary results from its ongoing Phase 3 UTOPIA trial, demonstrating a 77.8% three-month complete response rate with UGN-103 for intravesical solution in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. This result is consistent with the 79.6% three-month CR rate observed following treatment with ZUSDURI in the pivotal ENVISION trial. In addition, the U.S. Food and Drug Administration, FDA, agreed that CR and durability results from the UTOPIA trial can support the submission of a New Drug Application, NDA, for UGN-103 for recurrent LG-IR-NMIBC.
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