Core Viewpoint - UroGen Pharma Ltd. is facing a class action lawsuit due to allegations of misleading statements regarding the effectiveness of its lead pipeline product, UGN-102, during the class period from July 27, 2023, to May 15, 2025 [2] Group 1: Allegations - The complaint claims that the ENVISION clinical study was inadequately designed, lacking a concurrent control arm, which undermined its ability to demonstrate substantial evidence of UGN-102's effectiveness [2] - UroGen Pharma allegedly ignored 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] - Positive statements made by the company regarding its business and prospects were reportedly misleading and lacked a reasonable basis due to the aforementioned issues [2] Group 2: Class Action Details - Shareholders who purchased URGN shares during the specified class period are encouraged to register for the class action, with a deadline set for July 28, 2025 [3] - Upon registration, shareholders will receive updates through a portfolio monitoring software regarding the case's progress [3] - There is no cost or obligation for shareholders to participate in the class action [3] Group 3: Law Firm Information - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and fraud [4] - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [4]

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].

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].