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SHAREHOLDER NOTICE: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of UroGen
UroGen PharmaUroGen Pharma(US:URGN) GlobeNewswire News Room·2025-06-12 22:04

Core Viewpoint - UroGen Pharma Ltd. is facing potential legal claims due to allegations of misleading statements regarding the effectiveness of its drug UGN-102, particularly related to the ENVISION clinical study design and FDA warnings [5][6][7]. Group 1: Legal Investigation and Class Action - Faruqi & Faruqi, LLP is investigating claims against UroGen and has set a deadline of July 28, 2025, for investors to seek the role of lead plaintiff in a federal securities class action [3]. - Investors who purchased UroGen securities between July 27, 2023, and May 15, 2025, are encouraged to discuss their legal rights with the firm [1][3]. Group 2: Allegations Against UroGen - The complaint alleges that UroGen and its executives violated federal securities laws by making false or misleading statements regarding the ENVISION clinical study, which lacked a concurrent control arm [5]. - The FDA expressed doubts about the effectiveness of UGN-102, stating that the study design made it difficult to interpret primary endpoints [6][7]. - UroGen's stock price fell significantly following negative FDA feedback and the Oncologic Drugs Advisory Committee's vote against the NDA for UGN-102, with a drop of 25.8% on May 16, 2025, and 44.7% on May 21, 2025 [7][8].