Clinical Trial SuccessUGN-102 demonstrated an 82.3% 12-month duration of response by Kaplan-Meier estimate in patients who had achieved a complete response at three months after the first instillation.
Market PotentialThe UGN-102 target market may be far larger than the JELMYTO market, potentially exceeding $5 billion annually.
Regulatory ApprovalThe FDA accepted the NDA for UGN-102 with standard review and set a PDUFA date of June 13th, 2025, with a high likelihood of approval.