URGN INVESTOR NEWS: UroGen Pharma Ltd. has been Sued for Securities Fraud – Contact BFA Law before 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 the results of the ENVISION trial [1][2]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the District of New Jersey, captioned 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]. - The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased UroGen securities [2]. Group 2: Product and Trial Information - UroGen develops treatments for specialty cancers, with UGN-102 being an intravesical solution intended for low-grade intermediate risk non-muscle invasive bladder cancer [3]. - UroGen claimed that the ENVISION trial met its primary endpoint and that it had reached an agreement with the FDA to support an NDA submission [3]. Group 3: FDA Concerns and Stock Impact - The FDA had previously expressed significant concerns regarding the ENVISION trial, noting it lacked a concurrent control arm, which raised doubts about the data's sufficiency [4]. - Following the FDA's briefing document on May 16, 2025, UroGen's stock price fell by $2.54 per share, or nearly 26%, from $9.85 to $7.31 [5]. - On May 21, 2025, the Oncologic Drugs Advisory Committee voted against the approval of UGN-102, leading to a further decline of $3.37 per share, or nearly 45%, from $7.54 to $4.17 [6].