URGN SHAREHOLDERS: UroGen Pharma Ltd. Investors are Reminded of the Pending Securities Fraud Class Action – Contact BFA Law by July 28 Deadline (NASDAQ:URGN)

Core 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, titled Cockrell v. UroGen Pharma Ltd., et al., No. 3:25-cv-06088, and investors have until July 28, 2025, to seek lead plaintiff status [2]. Clinical Trial Issues - UroGen claimed that its ENVISION trial met its primary endpoint and that it had reached an agreement with the FDA for an NDA submission. However, the FDA had previously raised significant concerns about the trial's design, particularly its lack of a concurrent control arm [3][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].