UROGEN PHARMA LTD

UroGen Pharma announced the first patient dosed in the Phase 3 trial of UGN-103, a next-gen mitomycin formulation for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). UGN-103, using UroGen’s RTGel technology, aims to improve manufacturing, convenience, and cost. The UTOPIA study will enroll 87 patients, evaluating efficacy and safety over 15 months.

UroGen Pharma Ltd. submitted the NDA for UGN-102 (mitomycin) for intravesical solution, aiming to treat low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The NDA is supported by the Phase 3 ENVISION study, which showed a 79.6% complete response rate at three months and an 82.3% 12-month duration of response. UroGen anticipates FDA approval in early 2025, potentially offering an alternative to repeated surgeries.