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].

Core Viewpoint - A lawsuit has been filed against UroGen Pharma Ltd. and certain senior executives for potential violations of federal securities laws, particularly related to the company's claims about its lead product UGN-102 and its clinical trial results [1][2]. Company Overview - UroGen Pharma Ltd. specializes in 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, with claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased UroGen securities [2]. Clinical Trial Issues - UroGen claimed that its ENVISION trial met its primary endpoint and that it had reached an agreement with the FDA to support a New Drug Application (NDA) submission [3]. However, the FDA had previously expressed significant concerns regarding the trial's design, specifically its lack of a concurrent control arm [4]. Stock Performance - Following the FDA's briefing document on May 16, 2025, which questioned the effectiveness of UGN-102 due to the trial's design, UroGen's stock price fell by $2.54 per share, a decline of nearly 26%, from $9.85 to $7.31 [5]. - On May 21, 2025, after the Oncologic Drugs Advisory Committee voted against the approval of UGN-102's NDA, the stock price dropped by $3.37 per share, nearly 45%, from $7.54 to $4.17 [6].

SAN DIEGO, June 03, 2025 (GLOBE NEWSWIRE) -- Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of UroGen Pharma Ltd. (NASDAQ: URGN) securities between July 27, 2023 and May 15, 2025, both dates inclusive (the “Class Period”), have until July 28, 2025 to seek appointment as lead plaintiff of the UroGen class action lawsuit. Captioned Cockrell v. UroGen Pharma Ltd., 25-cv-06088 (D.N.J.), the UroGen class action lawsuit charges UroGen as well as certain of UroGen’s top current and former ...

Core Viewpoint - A class action lawsuit has been filed against UroGen Pharma Ltd. for allegedly making false statements regarding its lead product UGN-102 and its clinical study design, which may have misled investors [1][3]. Company Overview - UroGen Pharma Ltd. focuses on developing and commercializing solutions for specialty cancers, with its lead product being UGN-102, an intravesical solution for treating low-grade intermediate risk non-muscle invasive bladder cancer [2]. Allegations in the Lawsuit - The lawsuit claims that UroGen's ENVISION clinical study for UGN-102 was inadequately designed, lacking a concurrent control arm, which undermined the evidence of the product's effectiveness [3]. - It is alleged that UroGen ignored FDA warnings regarding the study design, leading to a significant risk that the NDA for UGN-102 would not be approved [3][4]. - Following the FDA's briefing document release on May 16, 2025, which criticized the study design, UroGen's stock price dropped nearly 26% [4]. - On May 21, 2025, the Oncologic Drugs Advisory Committee voted against the approval of UGN-102, resulting in a further stock price decline of nearly 45% [5].