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INVESTOR ALERT: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of UroGen
URGNUroGen Pharma(URGN) Prnewswire·2025-06-04 15:25

Core Viewpoint - UroGen Pharma Ltd. is facing a federal securities class action due to allegations of misleading statements regarding the effectiveness of its drug UGN-102, leading to significant stock price declines following negative FDA feedback and advisory committee votes [4][5][6]. Group 1: Legal Investigation and Class Action - Faruqi & Faruqi, LLP is investigating potential claims against UroGen and has set a deadline of July 28, 2025, for investors to seek the role of lead plaintiff in the class action [2]. - Investors who suffered losses exceeding 75,000inUroGenbetweenJuly27,2023,andMay15,2025,areencouragedtocontactthefirmforlegaloptions[1].Group2:AllegationsAgainstUroGen−ThecomplaintallegesthatUroGenanditsexecutivesviolatedfederalsecuritieslawsbymakingfalseormisleadingstatementsregardingtheENVISIONclinicalstudyanditsdesign[4].−Specificallegationsincludethelackofaconcurrentcontrolarminthestudy,whichunderminedtheabilitytodemonstratethedrug′seffectiveness,andfailuretoheedFDAwarningsaboutthestudydesign[4].Group3:StockPriceImpact−FollowingtheFDA′sbriefingdocumentonMay16,2025,whichexpresseddoubtsabouttheeffectivenessofUGN−102,UroGen′sstockpricefellby75,000 in UroGen between July 27, 2023, and May 15, 2025, are encouraged to contact the firm for legal options [1]. Group 2: Allegations Against UroGen - The complaint alleges that UroGen and its executives violated federal securities laws by making false or misleading statements regarding the ENVISION clinical study and its design [4]. - Specific allegations include the lack of a concurrent control arm in the study, which undermined the ability to demonstrate the drug's effectiveness, and failure to heed FDA warnings about the study design [4]. Group 3: Stock Price Impact - Following the FDA's briefing document on May 16, 2025, which expressed doubts about the effectiveness of UGN-102, UroGen's stock price fell by 2.54, or 25.8%, closing at 7.31pershare[5].−OnMay21,2025,aftertheadvisorycommitteevotedagainsttheapprovalofUGN−102,thestockpricedroppedby7.31 per share [5]. - On May 21, 2025, after the advisory committee voted against the approval of UGN-102, the stock price dropped by 3.37, or 44.7%, closing at $4.17 per share [6].