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]. Allegations - UroGen allegedly misrepresented the success of the ENVISION trial, claiming it met its primary endpoint and that there was an agreement with the FDA for NDA submission, despite the FDA expressing significant concerns about the trial's design [3][4]. Stock Performance - Following the FDA's briefing document on May 16, 2025, which raised doubts about the effectiveness of UGN-102, UroGen's stock price fell by $2.54, or nearly 26%, from $9.85 to $7.31 per share [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, or nearly 45%, from $7.54 to $4.17 per share [6].
URGN INVESTOR NOTICE: UroGen Pharma Ltd. Investors with Losses are Notified of the Ongoing Securities Fraud Class Action and July 28 Deadline – BFA Law (NASDAQ:URGN)