UroGen Pharma(US:URGN) Prnewswireยท2025-05-30 00:40Core Viewpoint - A class action has been filed against UroGen Pharma Ltd. due to allegations of improper trial conduct for its lead drug candidate UGN-102, which is intended for treating low-grade intermediate risk non-muscle invasive bladder cancer [1][2]. Group 1: Allegations and FDA Concerns - The complaint alleges that UroGen failed to conduct a proper trial for UGN-102, specifically that the ENVISION clinical study lacked a concurrent control arm, making it difficult to demonstrate the drug's effectiveness [5]. - On May 16, 2025, the FDA expressed doubts about the sufficiency of the submitted data for UGN-102, stating that the lack of a concurrent control arm complicated the interpretation of primary endpoints [3]. - The FDA had previously recommended a randomized trial design multiple times during UroGen's product development, which the company did not follow [3]. Group 2: Stock Price Impact - Following the FDA's briefing document release on May 16, 2025, UroGen's stock price fell by $2.54, or 25.8%, closing at $7.31 per share [3]. - After the Oncological Drugs Advisory Committee voted against the approval of UGN-102 on May 21, 2025, UroGen's stock price dropped by $3.37, or 44.7%, closing at $4.17 per share [4]. Group 3: Class Action Participation - Shareholders may be eligible to participate in the class action against UroGen Pharma Ltd., with options to serve as lead plaintiff or remain an absent class member [6].