Core Viewpoint - UroGen Pharma Ltd. is facing a securities fraud class action lawsuit due to alleged failures in disclosing critical information regarding the effectiveness of its drug UGN-102 and the design of the ENVISION clinical study [2]. Group 1: Lawsuit Details - The lawsuit claims that from July 27, 2023, to May 15, 2025, UroGen did not disclose that the ENVISION clinical study was inadequately designed, lacking a concurrent control arm, which is essential for demonstrating substantial evidence of effectiveness for UGN-102 [2]. - It is alleged that UroGen would struggle to prove that the duration of response endpoint was attributable to UGN-102 due to the study's design flaws [2]. - The complaint states that UroGen ignored warnings from the FDA regarding the study design used to support the drug application for UGN-102, leading to a significant risk that the New Drug Application (NDA) would not be approved [2]. - As a result of these issues, the positive statements made by UroGen about its business, operations, and prospects were deemed materially misleading and lacked a reasonable basis [2]. Group 2: Participation Information - Investors who suffered losses related to UroGen Pharma Ltd. are encouraged to participate in the ongoing securities fraud lawsuit, with a lead plaintiff deadline set for July 28, 2025 [2]. - Interested parties can contact the Law Offices of Frank R. Cruz for more information or to learn about their rights regarding the lawsuit [3][4].

Core Viewpoint - A class action lawsuit has been filed against UroGen Pharma Ltd. regarding allegations of securities fraud and unlawful business practices [2]. Group 1: Lawsuit Details - Investors are encouraged to contact Pomerantz LLP if they purchased UroGen securities during the Class Period, with a deadline to apply as Lead Plaintiff by July 28, 2025 [2]. - The lawsuit centers on whether UroGen and its officers engaged in fraudulent activities related to their securities [2]. Group 2: FDA and Drug Approval - The FDA raised concerns about UroGen's bladder cancer drug UGN-102, stating that the trial's primary endpoints were difficult to interpret due to the lack of a concurrent control arm [4]. - The FDA recommended a randomized trial design to address these concerns multiple times [4]. - Following the FDA's briefing, UroGen's stock price fell by $2.54 per share (25.79%) to close at $7.31 on May 16, 2025 [5]. - On May 21, 2025, the Oncologic Drugs Advisory Committee voted against the approval of UGN-102, leading to a further decline in UroGen's stock price by $3.37 per share (44.7%) to close at $4.17 [5].

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 $2.54 (25.8%) on May 16, 2025, and 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].

Core Viewpoint - Rosen Law Firm has filed a class action lawsuit on behalf of purchasers of UroGen Pharma Ltd. securities between July 27, 2023, and May 15, 2025, due to alleged misleading statements regarding the effectiveness of UGN-102, UroGen's lead pipeline product [1][5]. Group 1: Lawsuit Details - The class action lawsuit claims that UroGen made false and misleading statements about the ENVISION clinical study, which lacked a concurrent control arm, affecting the demonstration of UGN-102's effectiveness [5]. - The lawsuit alleges that UroGen ignored FDA warnings about the study design, leading to a substantial risk that the New Drug Application (NDA) for UGN-102 would not be approved [5]. - Investors are encouraged to join the class action without any out-of-pocket fees through a contingency fee arrangement [2][3]. Group 2: Legal Representation - Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions, highlighting its own achievements in recovering hundreds of millions for investors [4]. - The firm has been recognized for its leadership in securities class action settlements, including a notable settlement against a Chinese company [4]. - Investors can join the class action by submitting a form or contacting the firm directly for more information [3][6].

Core Viewpoint - A lawsuit has been filed against UroGen Pharma Ltd. and certain senior executives for potential violations of federal securities laws, specifically related to the company's claims about its lead product UGN-102 and its clinical trial results [1][2]. Company Overview - UroGen Pharma Ltd. focuses on developing treatments for specialty cancers, with its lead product being UGN-102, an intravesical solution aimed at treating low-grade intermediate risk non-muscle invasive bladder cancer [3]. Legal Proceedings - The lawsuit is pending in the U.S. District Court for the District of New Jersey, titled Cockrell v. UroGen Pharma Ltd., et al., No. 3:25-cv-06088, and investors have until July 28, 2025, to seek lead plaintiff status [2]. Allegations - UroGen allegedly misrepresented the success of the ENVISION trial, claiming it met its primary endpoint and that there was an agreement with the FDA for NDA submission, despite the FDA expressing significant concerns about the trial's design [3][4]. Stock Performance - Following the FDA's briefing document on May 16, 2025, which raised doubts about the effectiveness of UGN-102, UroGen's stock price fell by $2.54, or nearly 26%, from $9.85 to $7.31 per share [5]. - On May 21, 2025, after the Oncologic Drugs Advisory Committee voted against the approval of UGN-102, the stock price dropped by $3.37, or nearly 45%, from $7.54 to $4.17 per share [6].

Core Viewpoint - A class action securities lawsuit has been filed against UroGen Pharma Ltd. due to alleged securities fraud affecting investors between July 27, 2023, and May 15, 2025 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that UroGen Pharma Ltd. made false statements regarding the ENVISION clinical study, which was not adequately designed to demonstrate the effectiveness of its lead product, UGN-102, due to the absence of a concurrent control arm [2]. - It is alleged that UroGen Pharma Ltd. failed to address FDA warnings about the study design, leading to a significant risk that the New Drug Application (NDA) for UGN-102 would not be approved [2]. - The lawsuit asserts that the positive statements made by the defendants about the company's business and prospects were materially misleading and lacked a reasonable basis [2]. Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until July 28, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require serving as a lead plaintiff [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees, and there is no obligation to participate [3]. Group 3: Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions of dollars for shareholders over the past 20 years [4]. - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the leading securities litigation firms in the United States [4].

NEW YORK, June 5, 2025 /PRNewswire/ --Why: Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of securities of UroGen Pharma Ltd. (NASDAQ: URGN) between July 27, 2023 and May 15, 2025, both dates inclusive (the "Class Period"). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than July 28, 2025.So What: If you purchased UroGen securities during the Class Period you ma ...

SAN FRANCISCO, June 5, 2025 /PRNewswire/ -- A securities class action lawsuit styled Cockrell v. UroGen Pharma Ltd. et al., No. 3:25-cv-06088 (D. N.J.) has been filed and seeks to represent investors who purchased or otherwise acquired UroGen securities between July 27, 2023 and May 15, 2025.The lawsuit comes after investors saw the price of their shares in UroGen Pharma Ltd. (NASDAQ: URGN) crash on May 16, 2025 as a result of the FDA's publication of a briefing document a few days before an upcoming Oncolo ...

NEW YORK, June 05, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in UroGen Pharma Ltd. ("UroGen Pharma Ltd." or the "Company") (NASDAQ: URGN) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of UroGen Pharma Ltd. investors who were adversely affected by alleged securities fraud between July 27, 2023 and May 15, 2025. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra-1/urogen-p ...

NEW YORK, June 05, 2025 (GLOBE NEWSWIRE) -- Wolf Haldenstein Adler Freeman & Herz LLP announces that a securities class action lawsuit has been filed against UroGen Pharma Ltd. (NASDAQ: URGN) (“UroGen” or the “Company”) The lawsuit is on behalf of individuals or entities that purchased or acquired UroGen Pharma Ltd. securities between July 27, 2023 and May 15, 2025 (the “Class Period”). PLEASE CLICK HERE TO JOIN THE CASE AND SUBMIT CONTACT INFORMATION Allegations The lawsuit alleges that during the Class Pe ...