INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of UroGen Pharma Ltd.  - URGN
UroGen PharmaUroGen Pharma(US:URGN) GlobeNewswire News Room·2025-06-02 17:27

Core Viewpoint - UroGen Pharma Ltd. is under investigation for potential securities fraud and unlawful business practices, following concerns raised by the FDA regarding the trial design of its bladder cancer drug UGN-102 [1][3]. 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]. - Investors are encouraged to contact Pomerantz LLP for more information regarding the class action [2]. Group 2: FDA Concerns - The FDA's briefing document for the Oncologic Drugs Advisory Committee highlighted issues with UroGen's Envision trial, specifically the absence of a concurrent control arm, making the primary endpoints difficult to interpret [3]. - The FDA has recommended a randomized trial design to UroGen multiple times to address these concerns [3]. Group 3: Market Reaction - Following the FDA's announcement, UroGen's stock price dropped by $2.54 per share, representing a decline of 25.79%, closing at $7.31 per share on May 16, 2025 [4].