UGN-103 - (UTOPIA)

May 15, 2026: UroGen Pharma Ltd. (NASDAQ: URGN) reported 6‑month interim efficacy from the ongoing Phase 3 UTOPIA trial of UGN‑103 (mitomycin) intravesical solution in recurrent low‑grade intermediate‑risk non‑muscle invasive bladder cancer (LG‑IR‑NMIBC). UGN‑103 achieved a 94.5% durability of response (DOR) at six months (Kaplan‑Meier estimate; 95% CI: 86.1–97.9) in the study.

The company said the 6‑month DOR is generally consistent with the 91.9% (95% CI: 86.9–95.0) 6‑month DOR reported for ZUSDURI (mitomycin) in the pivotal ENVISION trial in patients meeting the same eligibility criteria; ZUSDURI is FDA‑approved for adults with recurrent LG‑IR‑NMIBC.

Regulatory catalyst: UroGen stated it remains on track, with FDA alignment, to submit a New Drug Application (NDA) for UGN‑103 in Q3 2026.

Trial details: UTOPIA is a single‑arm, multicenter trial (n=99) dosing 75 mg weekly for six weeks; primary endpoint is complete response (CR) at three months, with up to 12 months follow‑up to assess DOR.