URGN INVESTOR NOTICE: UroGen Pharma Ltd. Investors with Substantial Losses Have Opportunity to Lead Investor Class Action Lawsuit

Core Viewpoint - UroGen Pharma Ltd. is facing a class action lawsuit due to alleged violations of the Securities Exchange Act of 1934, with claims centered around misleading statements regarding the effectiveness of its lead product, UGN-102, and its clinical study design [1][3]. Company Overview - UroGen Pharma Ltd. specializes in developing and commercializing solutions for specialty cancers, with its primary product being UGN-102, an intravesical solution aimed at treating low-grade intermediate risk non-muscle invasive bladder cancer [2]. Allegations of the Lawsuit - The lawsuit claims that UroGen made false or misleading statements and failed to disclose critical information regarding the ENVISION clinical study for UGN-102, including: - The study was not designed to provide substantial evidence of effectiveness due to the absence of a concurrent control arm [3]. - UroGen's challenges in demonstrating that the duration of response was attributable to UGN-102 [3]. - Ignoring FDA warnings about the study design for the new drug application (NDA) [3]. - The substantial risk that the NDA for UGN-102 would not receive approval [3]. Impact of FDA Findings - On May 16, 2025, the FDA released a briefing document indicating concerns about the ENVISION study's design, stating that the primary endpoints were difficult to interpret due to the lack of a concurrent control arm. This led to a nearly 26% drop in UroGen's stock price [4]. - Following the FDA's Oncologic Drugs Advisory Committee vote against the approval of UGN-102 on May 21, 2025, citing unfavorable benefit-risk assessment, UroGen's stock price fell nearly 45% [5]. Lead Plaintiff Process - The Private Securities Litigation Reform Act of 1995 allows any investor who purchased UroGen securities during the class period to seek appointment as lead plaintiff in the lawsuit, representing the interests of all class members [6]. Law Firm Background - Robbins Geller Rudman & Dowd LLP is a leading law firm in securities fraud and shareholder litigation, having recovered over $2.5 billion for investors in 2024 alone, and is recognized for securing significant monetary relief for investors [7].