UroGen Pharma(URGN) Prnewswire·2025-05-20 22:06Core Viewpoint - UroGen Pharma Ltd. is under investigation for potential securities fraud and unlawful business practices, following concerns raised by the FDA regarding the clinical trial design of its bladder cancer drug UGN-102 [1][2]. Group 1: Investigation and Legal Actions - Pomerantz LLP is investigating claims on behalf of UroGen investors, focusing on possible securities fraud or other unlawful practices by the company and its officers [1]. - The investigation is prompted by the FDA's concerns regarding the Envision trial for UGN-102, which lacked a concurrent control arm, making the trial's primary endpoints difficult to interpret [2]. Group 2: FDA Concerns and Market Reaction - The FDA's briefing document indicated that it had recommended a randomized trial design to UroGen multiple times to address concerns about the trial's validity [2]. - Following the news of the FDA's concerns, UroGen's stock price dropped by 7.31 per share on May 16, 2025 [3].