UroGen Pharma Reports Positive Phase 1 Results For UGN-301 In Non-Muscle Invasive Bladder Cancer

(RTTNews) - UroGen Pharma Ltd. (URGN) announced encouraging safety data from the Phase 1 dose-escalation study for UGN-301 (zalifrelimab) intravesical solution, an investigational drug in development for the treatment of recurrent non-muscle invasive bladder cancer (NMIBC).

The company noted that UGN-301 demonstrated tolerability across all dose levels, with no dose-limiting toxicities or adverse events resulting in treatment discontinuation. The formulation of UGN-301 in a reverse thermal gel enabled sustained bladder exposure.

Additionally, some patients treated with UGN-301 (zalifrelimab) intravesical solution exhibited clinical activity during the week 12 disease assessment. These findings were presented at the 2025 American Urological Association Annual Meeting in Las Vegas, Nevada.

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