UROGEN ALERT: Bragar Eagel & Squire, P.C. Announces that a Class Action Lawsuit Has Been Filed Against UroGen Pharma Ltd.

Core Viewpoint - A class action lawsuit has been filed against UroGen Pharma Ltd. for allegedly making false statements regarding its lead product UGN-102 and its clinical study design, which may have misled investors [1][3]. Company Overview - UroGen Pharma Ltd. focuses on developing and commercializing solutions for specialty cancers, with its lead product being UGN-102, an intravesical solution for treating low-grade intermediate risk non-muscle invasive bladder cancer [2]. Allegations in the Lawsuit - The lawsuit claims that UroGen's ENVISION clinical study for UGN-102 was inadequately designed, lacking a concurrent control arm, which undermined the evidence of the product's effectiveness [3]. - It is alleged that UroGen ignored FDA warnings regarding the study design, leading to a significant risk that the NDA for UGN-102 would not be approved [3][4]. - Following the FDA's briefing document release on May 16, 2025, which criticized the study design, UroGen's stock price dropped nearly 26% [4]. - On May 21, 2025, the Oncologic Drugs Advisory Committee voted against the approval of UGN-102, resulting in a further stock price decline of nearly 45% [5].