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 primary 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 investors having until July 28, 2025, to seek lead plaintiff status [2]. - The complaint alleges violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, representing 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 raised significant concerns about the ENVISION trial, noting the absence 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, 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's NDA, 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 complaint alleges that UroGen Pharma Ltd. made false statements regarding the ENVISION clinical study, claiming it was not designed to provide substantial evidence of effectiveness for UGN-102 due to the absence of a concurrent control arm [2]. - It is claimed that UroGen Pharma Ltd. would struggle to demonstrate that the duration of response endpoint was attributable to UGN-102, and that the company ignored FDA warnings about the study design [2]. - The lawsuit suggests that there was a significant risk that the New Drug Application (NDA) for UGN-102 would not be approved, leading to misleading positive statements about the company's business and prospects [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, with no obligation to participate [3]. Group 3: Firm Background - Levi & Korsinsky, LLP has a history of securing hundreds of millions of dollars for shareholders and has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4].

NEW YORK, June 09, 2025 (GLOBE NEWSWIRE) -- 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: https://securitiesclasslaw.com/securities/urogen-pharma-ltd-loss-submission-form/?id=151949&from=3 CLASS PERIOD: July 27, ...

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 UroGen's lead pipeline product, UGN-102 [1][5]. Group 1: Lawsuit Details - The 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]. - It is alleged 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]. - The lawsuit asserts that when the true details were revealed, investors suffered damages due to the misleading nature of UroGen's positive statements about its business and prospects [5]. Group 2: Participation Information - Investors who purchased UroGen securities during the Class Period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - To join the class action, interested parties can visit the provided link or contact the law firm directly for more information [3][6].

Core Viewpoint - UroGen Pharma Ltd. is facing a securities fraud class action lawsuit alleging misrepresentations regarding the approval of its lead pipeline product, UGN-102, which may impact investor confidence and the company's market position [2][3]. Group 1: Lawsuit Details - The lawsuit was filed in the United States District Court for the District of New Jersey on behalf of investors who purchased UroGen securities between July 27, 2023, and May 15, 2025, alleging violations of the Securities Exchange Act of 1934 [2]. - Defendants in the lawsuit include UroGen and certain senior officers, accused of making false statements about the potential approval of the New Drug Application for UGN-102 [3]. Group 2: Legal Participation - Investors wishing to serve as lead plaintiffs must file necessary documents by July 28, 2025, although participation as a lead plaintiff is not required to share in any potential recovery [4]. - All legal representation in this case operates on a contingency fee basis, meaning shareholders incur no fees or expenses unless there is a recovery [4]. Group 3: Law Firm Background - Bernstein Liebhard LLP, the law firm handling the case, has recovered over $3.5 billion for clients since 1993 and has a strong track record in class action litigation [5]. - The firm has been recognized multiple times in The National Law Journal's "Plaintiffs' Hot List" and has been listed in The Legal 500 for sixteen consecutive years, indicating a reputable standing in the legal community [5].

NEW YORK, June 9, 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:https://securitiesclasslaw.com/securities/urogen-pharma-ltd-loss-submission-form/?id=151926&from=4CLASS PERIOD: July 27, 2023 to ...

SAN DIEGO, June 09, 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, all 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 e ...

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 the results of the ENVISION trial [1][2]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the District of New Jersey, captioned 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]. - The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased UroGen securities [2]. Group 2: Product and Trial Information - UroGen develops treatments for specialty cancers, with UGN-102 being an intravesical solution intended for low-grade intermediate risk non-muscle invasive bladder cancer [3]. - UroGen claimed that the ENVISION trial met its primary endpoint and that it had reached an agreement with the FDA to support an NDA submission [3]. Group 3: FDA Concerns and Stock Impact - The FDA had previously expressed significant concerns regarding the ENVISION trial, noting it lacked a concurrent control arm, which raised doubts about the data's sufficiency [4]. - Following the FDA's briefing document on May 16, 2025, UroGen's stock price fell by $2.54 per share, or nearly 26%, from $9.85 to $7.31 [5]. - On May 21, 2025, the Oncologic Drugs Advisory Committee voted against the approval of UGN-102, leading to a further decline of $3.37 per share, or nearly 45%, from $7.54 to $4.17 [6].

Core Viewpoint - UroGen Pharma Ltd. is facing a class action lawsuit alleging violations of the Securities Exchange Act of 1934 due to misleading statements regarding its lead product UGN-102 and its clinical study design [1][3]. Group 1: Class Action Lawsuit Details - The class action lawsuit is titled Cockrell v. UroGen Pharma Ltd., and it includes purchasers of UroGen securities from July 27, 2023, to May 15, 2025 [1]. - Investors have until July 28, 2025, to seek appointment as lead plaintiff in the lawsuit [1]. - The lawsuit claims that UroGen's clinical study for UGN-102 was inadequately designed, lacking a concurrent control arm, which undermined the evidence of its effectiveness [3]. Group 2: Allegations Against UroGen - The lawsuit alleges that UroGen ignored FDA warnings regarding the study design for UGN-102, which could jeopardize the approval of its New Drug Application (NDA) [3][4]. - Following the FDA's briefing document on May 16, 2025, which criticized the study design, UroGen's stock price fell nearly 26% [4]. - On May 21, 2025, the Oncologic Drugs Advisory Committee voted against the approval of UGN-102, leading to a further decline of nearly 45% in UroGen's stock price [5]. Group 3: Legal Process and Firm Background - The Private Securities Litigation Reform Act of 1995 allows any investor who purchased UroGen securities during the class period to seek lead plaintiff status [6]. - Robbins Geller Rudman & Dowd LLP is a leading law firm in securities fraud litigation, having recovered over $2.5 billion for investors in 2024 alone [7].

Core Viewpoint - A class action has been filed against UroGen Pharma Ltd. due to allegations of improper trial conduct for its lead drug candidate, UGN-102, which is intended to treat low-grade intermediate risk non-muscle invasive bladder cancer [1][2]. Summary by Sections Allegations - Robbins LLP is investigating allegations that UroGen Pharma Ltd. failed to conduct a proper trial for UGN-102, with the rolling new drug application (NDA) submitted on August 14, 2024 [2]. FDA Concerns - On May 16, 2025, the FDA expressed doubts regarding the efficacy data submitted for UGN-102, highlighting that the ENVISION study lacked a concurrent control arm, making the primary endpoints difficult to interpret [3]. - The FDA had previously recommended a randomized trial design multiple times during the product's development, which UroGen did not follow [3]. Stock Price Impact - Following the FDA's concerns, UroGen's stock price dropped by $2.54, or 25.8%, closing at $7.31 per share on May 16, 2025 [3]. - On May 21, 2025, the Oncologic Drugs Advisory Committee voted against the approval of UGN-102, leading to a further decline in stock price by $3.37, or 44.7%, closing at $4.17 per share [4]. Class Action Details - The complaint alleges that UroGen did not disclose critical information regarding the study design and its implications for the NDA approval process, including the lack of a concurrent control arm and the challenges in demonstrating the drug's effectiveness [5]. - Shareholders may be eligible to participate in the class action, with options to serve as lead plaintiff or remain absent class members [6]. Company Background - Robbins LLP has been recognized for its efforts in shareholder rights litigation, focusing on helping shareholders recover losses and improve corporate governance since 2002 [7].