URGN Class Action News: UroGen Pharma Ltd. Investors with Large Losses Should Contact Robbins LLP Before July 28 for Information About Leading the Class Action

Core Viewpoint - A class action has been filed against UroGen Pharma Ltd. for allegedly failing to conduct a proper trial for its lead drug candidate, UGN-102, which is intended to treat low-grade intermediate risk non-muscle invasive bladder cancer [1][2]. Group 1: Allegations and FDA Concerns - The complaint alleges that the FDA expressed doubts about the effectiveness of UGN-102 due to the lack of a concurrent control arm in the ENVISION clinical study, making the primary endpoints difficult to interpret [3]. - The FDA had recommended a randomized trial design multiple times during UroGen's product development, but the company chose not to follow this advice [3]. - Following the FDA's briefing document, UroGen's stock price fell by $2.54, or 25.8%, closing at $7.31 per share on May 16, 2025 [3]. Group 2: Advisory Committee Vote and Stock Impact - On May 21, 2025, the Oncological Drugs Advisory Committee voted against the approval of UGN-102, citing an unfavorable benefit-risk profile for patients [4]. - This negative vote led to a significant drop in UroGen's stock price, which fell by $3.37, or 44.7%, closing at $4.17 per share on the same day [4]. Group 3: Class Action Participation - Shareholders interested in participating in the class action must file their motion for lead plaintiff by July 28, 2025, with the lead plaintiff representing other class members in the litigation [6]. - Shareholders can choose to remain absent class members without participating in the case [6].