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 ...

NEW YORK, June 5, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of UroGen Pharma Ltd. (NASDAQ: URGN). Shareholders who purchased shares of URGN during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: WHY GROSS LAW FIRM? The Gross Law Firm is a nationally recognized class action law firm, and our mission is to protect the rig ...

SAN FRANCISCO, June 04, 2025 (GLOBE NEWSWIRE) -- 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 ...

Core Viewpoint - UroGen Pharma Ltd. faces a class action lawsuit following significant stock price declines due to the FDA's negative assessment of its drug application for UGN-102, which raised concerns about the drug's efficacy and study design [2][3][4]. Group 1: Company Overview - UroGen Pharma Ltd. is involved in the development of UGN-102, a drug intended for treating recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer [3]. - The company submitted a new drug application (NDA) for UGN-102, which was met with skepticism from the FDA regarding the sufficiency of the submitted data [2]. Group 2: FDA Findings - The FDA's briefing document indicated doubts about the effectiveness of UGN-102, citing the lack of a concurrent control arm in the ENVISION trial, making the primary endpoints difficult to interpret [2]. - The FDA had previously recommended a randomized trial design to UroGen but the company opted not to follow this guidance [2]. Group 3: Stock Price Impact - Following the FDA's briefing document release on May 16, 2025, UroGen's stock price dropped by $2.54, or 25.8%, closing at $7.31 per share [2]. - After the Oncologic Drugs Advisory Committee voted against the NDA on May 21, 2025, the stock fell further by $3.37, or 44.7%, closing at $4.17 per share [3]. Group 4: Lawsuit Details - The class action lawsuit alleges that UroGen made materially false and misleading statements regarding the effectiveness of UGN-102 and failed to disclose significant risks associated with the drug's approval process [4]. - Specific allegations include the inadequacy of the ENVISION clinical study design and the company's disregard for FDA recommendations, leading to a substantial risk of NDA rejection [4].

Core Viewpoint - UroGen Pharma Ltd. is facing a federal securities class action due to allegations of misleading statements regarding the effectiveness of its drug UGN-102, leading to significant stock price declines following negative FDA feedback and advisory committee votes [4][5][6]. Group 1: Legal Investigation and Class Action - Faruqi & Faruqi, LLP is investigating potential claims against UroGen and has set a deadline of July 28, 2025, for investors to seek the role of lead plaintiff in the class action [2]. - Investors who suffered losses exceeding $75,000 in UroGen between July 27, 2023, and May 15, 2025, are encouraged to contact the firm for legal options [1]. 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 and its design [4]. - Specific allegations include the lack of a concurrent control arm in the study, which undermined the ability to demonstrate the drug's effectiveness, and failure to heed FDA warnings about the study design [4]. Group 3: Stock Price Impact - Following the FDA's briefing document on May 16, 2025, which expressed doubts about the effectiveness of UGN-102, UroGen's stock price fell by $2.54, or 25.8%, closing at $7.31 per share [5]. - On May 21, 2025, after the advisory committee voted against the approval of UGN-102, the stock price dropped by $3.37, or 44.7%, closing at $4.17 per share [6].

NEW YORK, June 04, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against UroGen Pharma Ltd. (NASDAQ: URGN) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in UroGen you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/urogen-pharma-ltd-class-action-lawsuit. Investors have until July 28, 2025, to ask the Court ...