Core Viewpoint - UroGen Pharma Ltd. is facing a securities fraud class action lawsuit due to alleged failures in disclosing critical information regarding the effectiveness of its drug UGN-102 and the design of the ENVISION clinical study [2]. Group 1: Lawsuit Details - The lawsuit claims that from July 27, 2023, to May 15, 2025, UroGen did not disclose that the ENVISION clinical study was inadequately designed, lacking a concurrent control arm, which is essential for demonstrating substantial evidence of effectiveness for UGN-102 [2]. - It is alleged that UroGen would struggle to prove that the duration of response endpoint was attributable to UGN-102 due to the study's design flaws [2]. - The complaint states that UroGen ignored warnings from the FDA regarding the study design used to support the drug application for UGN-102, leading to a significant risk that the New Drug Application (NDA) would not be approved [2]. - As a result of these issues, the positive statements made by UroGen about its business, operations, and prospects were deemed materially misleading and lacked a reasonable basis [2]. Group 2: Participation Information - Investors who suffered losses related to UroGen Pharma Ltd. are encouraged to participate in the ongoing securities fraud lawsuit, with a lead plaintiff deadline set for July 28, 2025 [2]. - Interested parties can contact the Law Offices of Frank R. Cruz for more information or to learn about their rights regarding the lawsuit [3][4].
UroGen Pharma Ltd. (URGN) Investors Who Lost Money Have Opportunity to Lead Securities Fraud Lawsuit