UGN-103 - (UTOPIA)

August 17, 2026: UroGen Pharma Ltd. (NASDAQ: URGN) announced submission of an NDA to the FDA for UGN-103 (mitomycin) for intravesical solution for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

The filing is supported by data from the ongoing Phase 3 UTOPIA trial, a single-arm, multicenter study in 99 patients. In UTOPIA, UGN-103 showed a 77.8% complete response rate at three months (95% CI: 68.3%, 85.5%) and a 94.5% six-month duration of response by Kaplan-Meier estimate (95% CI: 86.1%, 97.9%). The company said these results were consistent with those seen in the pivotal ENVISION trial of ZUSDURI, while noting no formal cross-trial comparison was performed.

UTOPIA is evaluating 75 mg UGN-103 given by intravesical instillation once weekly for six weeks, with responders followed for up to 12 months for duration of response.

The release also states UroGen entered a licensing and supply agreement with medac in January 2024 to develop UGN-103. No FDA acceptance or action date for the NDA was provided.