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INVESTOR ALERT: Class Action Lawsuit Filed on Behalf of UroGen Pharma Ltd. (URGN) Investors – Holzer & Holzer, LLC Encourages Investors With Significant Losses to Contact the Firm
UroGen PharmaUroGen Pharma(US:URGN) GlobeNewswire News Room·2025-05-30 14:44

Core Viewpoint - A shareholder class action lawsuit has been filed against UroGen Pharma Ltd, alleging that the company made materially false and misleading statements regarding its business and the effectiveness of its drug UGN-102 [1] Group 1: Allegations in the Lawsuit - The lawsuit claims that the ENVISION clinical study was not properly designed to demonstrate substantial evidence of effectiveness for UGN-102 due to the absence of a concurrent control arm [1] - It is alleged that UroGen would face challenges in proving that the duration of response endpoint was attributable to UGN-102 [1] - The company reportedly ignored FDA warnings concerning the study design used to support the drug application for UGN-102 [1] - As a result of these issues, there is a significant risk that the New Drug Application (NDA) for UGN-102 may not receive approval [1] - Consequently, the positive statements made by the defendants regarding UroGen's business and prospects are claimed to be materially misleading and lacking a reasonable basis [1]