NasdaqGM:URGNBiotechs
UGN-103 NDA Filing for Recurrent Bladder Cancer Might Change The Case For Investing In UroGen Pharma (URGN)
On 17 August 2026, UroGen Pharma announced it had submitted a New Drug Application to the FDA for UGN-103, a next-generation mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, supported by Phase 3 UTOPIA data showing a three-month complete response rate and six-month durability of response.
The filing aims to extend UroGen’s RTGel-based bladder cancer franchise beyond ZUSDURI, potentially offering physicians a more streamlined...