URGN Investors with Large Losses Should Contact Robbins LLP for Information About the Class Action Lawsuit Against UroGen Pharma Ltd.

Core 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 to treat low-grade intermediate risk non-muscle invasive bladder cancer [1][2]. Summary by Sections Allegations - Robbins LLP is investigating allegations that UroGen Pharma Ltd. failed to conduct a proper trial for UGN-102, with the rolling new drug application (NDA) submitted on August 14, 2024 [2]. FDA Concerns - On May 16, 2025, the FDA expressed doubts regarding the efficacy data submitted for UGN-102, highlighting that the ENVISION study lacked a concurrent control arm, making the primary endpoints difficult to interpret [3]. - The FDA had previously recommended a randomized trial design multiple times during the product's development, which UroGen did not follow [3]. Stock Price Impact - Following the FDA's concerns, UroGen's stock price dropped by $2.54, or 25.8%, closing at $7.31 per share on May 16, 2025 [3]. - On May 21, 2025, the Oncologic Drugs Advisory Committee voted against the approval of UGN-102, leading to a further decline in stock price by $3.37, or 44.7%, closing at $4.17 per share [4]. Class Action Details - The complaint alleges that UroGen did not disclose critical information regarding the study design and its implications for the NDA approval process, including the lack of a concurrent control arm and the challenges in demonstrating the drug's effectiveness [5]. - Shareholders may be eligible to participate in the class action, with options to serve as lead plaintiff or remain absent class members [6]. Company Background - Robbins LLP has been recognized for its efforts in shareholder rights litigation, focusing on helping shareholders recover losses and improve corporate governance since 2002 [7].