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].

Core Viewpoint - UroGen Pharma Ltd. is under investigation for potential securities fraud and unlawful business practices, following concerns raised by the FDA regarding the trial design of its bladder cancer drug UGN-102 [1][3]. Group 1: Investigation and Legal Actions - Pomerantz LLP is investigating claims on behalf of UroGen investors, focusing on possible securities fraud or other unlawful practices by the company and its officers [1]. - Investors are encouraged to contact Pomerantz LLP for more information regarding the class action [2]. Group 2: FDA Concerns - The FDA's briefing document for the Oncologic Drugs Advisory Committee highlighted issues with UroGen's Envision trial, specifically the absence of a concurrent control arm, making the primary endpoints difficult to interpret [3]. - The FDA has recommended a randomized trial design to UroGen multiple times to address these concerns [3]. Group 3: Market Reaction - Following the FDA's announcement, UroGen's stock price dropped by $2.54 per share, representing a decline of 25.79%, closing at $7.31 per share on May 16, 2025 [4].

Core Viewpoint - A class action lawsuit has been filed against UroGen Pharma Ltd. for alleged violations of securities laws, specifically related to misleading statements about its clinical study for UGN-102 [1][4]. Group 1: Lawsuit Details - The lawsuit pertains to investors who purchased UroGen's securities between July 27, 2023, and May 15, 2025, during the defined "Class Period" [2]. - The Schall Law Firm is encouraging affected shareholders to contact them before July 28, 2025, to discuss their rights [2][3]. Group 2: Allegations Against UroGen - The complaint alleges that UroGen made false and misleading statements regarding the effectiveness of its ENVISION clinical study for UGN-102, which lacked a concurrent control arm [4]. - UroGen reportedly failed to adequately demonstrate that the duration of response endpoint could be attributed to UGN-102 and ignored FDA warnings about its study design [4]. - As a result of these misleading statements, investors suffered damages when the truth about UroGen's situation became known [4].

SAN DIEGO, June 2, 2025 /PRNewswire/ -- 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 and certain of UroGen's top current and former executives ...

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, with investors having until July 28, 2025, to seek appointment to lead the case [2]. - The complaint alleges violations 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 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, 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, the stock price dropped by $3.37 per share, nearly 45%, from $7.54 to $4.17 [6].

NEW YORK, May 31, 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 t ...

NEW YORK, May 30, 2025 (GLOBE NEWSWIRE) -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against UroGen Pharma Ltd. (“UroGen” or “the Company”) (NASDAQ: URGN) and certain of its officers. Class Definition This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acquired UroGen secu ...