URGN LAWSUIT NOTICE: Lose Money on UroGen Pharma Ltd.? BFA Law Alerts Investors that the Class Action Could Allow Investors to Recover Losses (NASDAQ:URGN)

Core Viewpoint - A lawsuit has been filed against UroGen Pharma Ltd. and certain senior executives for potential violations of federal securities laws, particularly related to the company's claims about its lead product UGN-102 and its clinical trial results [1][2]. Company Overview - UroGen Pharma Ltd. specializes in 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 claims 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 its lack 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 due to the trial's design, 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's NDA, the stock price dropped by $3.37 per share, nearly 45%, from $7.54 to $4.17 [6].