UROGEN ALERT: Bragar Eagel & Squire, P.C. Reminds Investors of the Class Action Lawsuit Against UroGen Pharma Ltd.

Core Viewpoint - A class action lawsuit has been filed against UroGen Pharma Ltd. for alleged misleading statements regarding its lead product UGN-102, which is intended to treat low-grade intermediate risk non-muscle invasive bladder cancer [1][2][3]. Company Overview - UroGen Pharma Ltd. focuses on developing and commercializing solutions for specialty cancers, with its primary product being UGN-102, an intravesical solution for bladder cancer treatment [2]. Allegations in the Lawsuit - The lawsuit claims that UroGen made false statements and failed to disclose critical information about the ENVISION clinical study for UGN-102, including: - The study was not designed to provide substantial evidence of effectiveness due to the absence of a concurrent control arm [3]. - UroGen faced challenges in demonstrating that the duration of response was attributable to UGN-102 [3]. - The company ignored FDA warnings regarding the study design for the new drug application (NDA) [3]. - There was a significant risk that the NDA for UGN-102 would not receive approval [3]. Impact of FDA Findings - On May 16, 2025, the FDA released a briefing document indicating concerns about the ENVISION study's design, stating that the primary endpoints were difficult to interpret due to the lack of a concurrent control arm. This led to a nearly 26% drop in UroGen's stock price [4]. - Following the FDA's Oncologic Drugs Advisory Committee vote against the NDA for UGN-102 on May 21, 2025, citing unfavorable benefit-risk assessment, UroGen's stock price fell nearly 45% [5].