Clinical Impact And Regulatory ProgressInitial UTOPIA pivotal data confirm UGN-103 clinical impact in-line with ZUSDURI, with the FDA agreeing to the regulatory plan to submit a New Drug Application.
Market DemandUroGen management indicated strong market demand for ZUSDURI, as evidenced by roughly $4.5M in preliminary demand revenue estimated during the month of October 2025 alone.
Revenue GrowthStrong initial demand should translate to Q4 inflection with more to follow the permanent J code, leading to more rapid and robust revenue recording.