URGN INVESTOR ALERT: Robbins Geller Rudman & Dowd LLP Announces that UroGen Pharma Ltd. Investors with Substantial Losses Have Opportunity to Lead the UroGen 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, including: - The ENVISION clinical study for UGN-102 was inadequately designed, lacking a concurrent control arm, which undermined its ability to demonstrate substantial evidence of effectiveness [3]. - UroGen did not adequately address FDA warnings regarding the study design for its new drug application (NDA) for UGN-102, leading to a significant risk of NDA rejection [3][4]. 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 absence 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 any investor who purchased UroGen securities during the specified class period to seek appointment as lead plaintiff in the class action lawsuit. The lead plaintiff represents the interests of all class members [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 obtaining significant recoveries in securities class action cases [7].