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UroGen Pharma Ltd. (URGN) Faces Securities Class Action Amid FDA's Briefing Document and Subsequent ODAC Vote Against UGN-102 – Hagens Berman
UroGen PharmaUroGen Pharma(US:URGN) GlobeNewswire News Room·2025-05-30 18:23

Core Viewpoint - A securities class action lawsuit has been filed against UroGen Pharma Ltd. due to significant share price decline following FDA concerns regarding the company's drug application for UGN-102 [1][2]. Group 1: Lawsuit Details - The lawsuit, Cockrell v. UroGen Pharma Ltd., seeks to represent investors who acquired UroGen securities between July 27, 2023, and May 15, 2025 [1]. - The litigation focuses on UroGen's disclosures about its communications with the FDA regarding the UGN-102 NDA, particularly the design of the pivotal trial ENVISION [3][4]. Group 2: FDA Concerns - The FDA's briefing document indicated that UroGen was advised to conduct a randomized trial for UGN-102 due to concerns about efficacy interpretation and safety data [5]. - The FDA noted that the ENVISION trial lacked a concurrent control arm, making it difficult to interpret primary endpoints such as complete response and duration of response [5]. Group 3: Impact on Share Price - Following the FDA's publication of the briefing document, UroGen's share price experienced a sharp decline on May 16, 2025, leading to substantial losses for investors [2][5]. - On May 21, 2025, it was reported that the ODAC voted 5 to 4 against the risk/profile of UGN-102, further impacting investor confidence [5].