Core Viewpoint - UroGen Pharma Ltd. is facing potential legal claims due to allegations of misleading statements regarding the effectiveness of its drug UGN-102, particularly related to the ENVISION clinical study design and FDA warnings [5][6][7]. Group 1: Legal Investigation and Class Action - Faruqi & Faruqi, LLP is investigating claims against UroGen and has set a deadline of July 28, 2025, for investors to seek the role of lead plaintiff in a federal securities class action [3]. - Investors who suffered losses in UroGen between July 27, 2023, and May 15, 2025, are encouraged to contact the firm to discuss their legal rights [1][3]. Group 2: Allegations Against UroGen - The complaint alleges that UroGen and its executives violated federal securities laws by making false or misleading statements regarding the ENVISION clinical study, which lacked a concurrent control arm [5]. - The FDA expressed doubts about the effectiveness of UGN-102, stating that the study design made it difficult to interpret primary endpoints [6][7]. - Following the FDA's briefing document, UroGen's stock price fell by 3.37 (44.7%) on May 21, 2025, after the Oncologic Drugs Advisory Committee voted against the drug's approval [7][8]. Group 3: Class Action Participation - The lead plaintiff in a class action is the investor with the largest financial interest who directs the litigation on behalf of the class [9]. - Any member of the class can move the court to serve as lead plaintiff or remain an absent class member without affecting their ability to share in any recovery [9].
DEADLINE ALERT: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of UroGen