INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of UroGen Pharma Ltd. - URGN

Core Viewpoint - UroGen Pharma Ltd. is under investigation for potential securities fraud and unlawful business practices following negative FDA feedback on its bladder cancer drug UGN-102 [1][3]. Group 1: FDA Review and Drug Approval - The FDA's briefing document indicated that UroGen's Envision trial lacked a concurrent control arm, making the interpretation of primary endpoints challenging [3]. - The FDA recommended a randomized trial design multiple times to address concerns regarding the trial's results [3]. - On May 21, 2025, the Oncologic Drugs Advisory Committee voted against the NDA for UGN-102, citing an unfavorable benefit-risk profile for patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer [4]. Group 2: Stock Price Impact - Following the FDA's briefing document release on May 16, 2025, UroGen's stock price dropped by $2.54, or 25.79%, closing at $7.31 per share [4]. - After the advisory committee's negative vote on May 21, 2025, UroGen's stock price fell by $3.37, or 44.7%, closing at $4.17 per share [4].