URGN INVESTOR ALERT: UroGen Pharma Ltd. Investors with Substantial Losses Have Opportunity to Lead 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 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]. Legal Process for Lead Plaintiff - The Private Securities Litigation Reform Act of 1995 allows investors who purchased UroGen securities during the class period to seek appointment as lead plaintiff, representing the interests of the class [6]. Law Firm Background - Robbins Geller Rudman & Dowd LLP is a prominent law firm specializing in securities fraud and shareholder litigation, having secured over $2.5 billion for investors in 2024 alone, and is recognized for its significant recoveries in securities class action cases [7].