UroGen Pharma(US:URGN) GlobeNewswire News Roomยท2025-06-02 12:46Core Viewpoint - A lawsuit has been filed against UroGen Pharma Ltd. and certain senior executives for potential violations of federal securities laws, specifically related to the company's claims about its lead product UGN-102 and its clinical trial results [1][2]. Company Overview - UroGen Pharma Ltd. focuses on developing treatments for specialty cancers, with its lead product being UGN-102, an intravesical solution aimed at treating low-grade intermediate risk non-muscle invasive bladder cancer [3]. Legal Proceedings - The lawsuit is pending in the U.S. District Court for the District of New Jersey, with investors having until July 28, 2025, to seek appointment to lead the case [2]. - The complaint alleges violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased UroGen securities [2]. Clinical Trial Issues - UroGen claimed that its ENVISION trial met its primary endpoint and that it had reached an agreement with the FDA to support a New Drug Application (NDA) submission [3]. - However, the FDA had previously expressed significant concerns regarding the trial's design, specifically noting the absence of a concurrent control arm [4]. Stock Performance - Following the FDA's briefing document on May 16, 2025, which questioned the effectiveness of UGN-102, UroGen's stock price fell by $2.54 per share, a decline of nearly 26%, from $9.85 to $7.31 [5]. - On May 21, 2025, after the Oncologic Drugs Advisory Committee voted against the approval of UGN-102, the stock price dropped by $3.37 per share, nearly 45%, from $7.54 to $4.17 [6].