Core Viewpoint - A class action lawsuit has been filed against UroGen Pharma Ltd. for alleged misleading statements regarding its lead product UGN-102, which is intended for treating low-grade intermediate risk non-muscle invasive bladder cancer [1][3]. Company Overview - UroGen Pharma is engaged in the development and commercialization of solutions for specialty cancers, with its lead pipeline product being UGN-102, an intravesical solution for bladder cancer treatment [2]. Allegations in the Lawsuit - The lawsuit claims that UroGen made false statements and failed to disclose critical information about the ENVISION clinical study for UGN-102, including the lack of a concurrent control arm, which undermined the study's ability to demonstrate effectiveness [3]. - It is alleged that UroGen ignored FDA warnings regarding the study design for the new drug application (NDA) for UGN-102, leading to a substantial 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, which contributed to a nearly 26% drop in UroGen's stock price [4]. - Following the Oncologic Drugs Advisory Committee's vote against the approval of UGN-102 on May 21, 2025, UroGen's stock price fell nearly 45% [5].
UROGEN FINAL DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds UroGen Pharma (URGN) Investors of the July 28th Deadline and Urges Investors in to Inquire About Their Rights in Class Action Lawsuit