UroGen Pharma(US:URGN) Prnewswire·2025-06-15 14:17Core 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 decisions [4][5][6]. Group 1: Legal Action and Investor Information - Faruqi & Faruqi, LLP is investigating potential claims against UroGen and reminds investors of the July 28, 2025 deadline to seek the role of lead plaintiff in the class action [2]. - Investors who suffered losses exceeding $75,000 in UroGen between July 27, 2023, and May 15, 2025, are encouraged to contact the firm for legal options [1]. - The court-appointed lead plaintiff will represent the interests of the class and any member can move to serve as lead plaintiff [7]. Group 2: Allegations Against UroGen - The complaint alleges that UroGen and its executives violated federal securities laws by making false statements and failing to disclose critical information about the ENVISION clinical study [4]. - Specific allegations include the study's lack of a concurrent control arm, which undermined the ability to demonstrate the drug's effectiveness, and the company's disregard for FDA warnings regarding study design [4]. - As a result of these issues, there was a substantial risk that the new drug application (NDA) for UGN-102 would not be approved, leading to misleading positive statements about the company's prospects [4]. Group 3: Stock Price Impact - Following the FDA's briefing document questioning the effectiveness of UGN-102, UroGen's stock price fell by $2.54, or 25.8%, closing at $7.31 per share on May 16, 2025 [5]. - After the Oncologic Drugs Advisory Committee voted against the NDA for UGN-102, the stock price dropped by $3.37, or 44.7%, closing at $4.17 per share on May 21, 2025 [6].