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 ...

Core Viewpoint - A class action has been filed against UroGen Pharma Ltd. for allegedly failing to conduct a proper trial for its lead drug candidate, UGN-102, which is intended to treat low-grade intermediate risk non-muscle invasive bladder cancer [1][2]. Group 1: Allegations and FDA Concerns - The complaint alleges that UroGen submitted a rolling new drug application (NDA) for UGN-102 on August 14, 2024 [2]. - On May 16, 2025, the FDA expressed doubts about the sufficiency of the submitted data for UGN-102's effectiveness, highlighting the lack of a concurrent control arm in the ENVISION clinical study [3]. - The FDA had previously recommended a randomized trial design to UroGen multiple times, which the company did not follow [3]. Group 2: Stock Price Impact - Following the FDA's briefing document on May 16, 2025, UroGen's stock price fell by $2.54, or 25.8%, closing at $7.31 per share [3]. - After the Oncological Drugs Advisory Committee voted against the approval of UGN-102 on May 21, 2025, UroGen's stock price dropped by $3.37, or 44.7%, closing at $4.17 per share [4]. Group 3: Class Action Details - The plaintiff claims that UroGen failed to disclose critical information regarding the study design and its implications for the NDA approval process [5]. - Shareholders interested in participating in the class action can contact Robbins LLP, which is leading the litigation [6].

Core Viewpoint - A securities class action lawsuit has been filed against UroGen Pharma Ltd. due to significant share price decline following FDA concerns regarding the company's drug application for UGN-102 [1][2]. Group 1: Lawsuit Details - The lawsuit, Cockrell v. UroGen Pharma Ltd., seeks to represent investors who acquired UroGen securities between July 27, 2023, and May 15, 2025 [1]. - The litigation focuses on UroGen's disclosures about its communications with the FDA regarding the UGN-102 NDA, particularly the design of the pivotal trial ENVISION [3][4]. Group 2: FDA Concerns - The FDA's briefing document indicated that UroGen was advised to conduct a randomized trial for UGN-102 due to concerns about efficacy interpretation and safety data [5]. - The FDA noted that the ENVISION trial lacked a concurrent control arm, making it difficult to interpret primary endpoints such as complete response and duration of response [5]. Group 3: Impact on Share Price - Following the FDA's publication of the briefing document, UroGen's share price experienced a sharp decline on May 16, 2025, leading to substantial losses for investors [2][5]. - On May 21, 2025, it was reported that the ODAC voted 5 to 4 against the risk/profile of UGN-102, further impacting investor confidence [5].

Core Viewpoint - A shareholder class action lawsuit has been filed against UroGen Pharma Ltd, alleging that the company made materially false and misleading statements regarding its business and the effectiveness of its drug UGN-102 [1] Group 1: Allegations in the Lawsuit - The lawsuit claims that the ENVISION clinical study was not properly designed to demonstrate substantial evidence of effectiveness for UGN-102 due to the absence of a concurrent control arm [1] - It is alleged that UroGen would face challenges in proving that the duration of response endpoint was attributable to UGN-102 [1] - The company reportedly ignored FDA warnings concerning the study design used to support the drug application for UGN-102 [1] - As a result of these issues, there is a significant risk that the New Drug Application (NDA) for UGN-102 may not receive approval [1] - Consequently, the positive statements made by the defendants regarding UroGen's business and prospects are claimed to be materially misleading and lacking a reasonable basis [1]

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $75,000 In UroGen To Contact Him Directly To Discuss Their OptionsIf you suffered losses exceeding $75,000 in UroGen between July 27, 2023 and May 15, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310).[You may also click here for additional information]NEW YORK, May 30, 2025 /PRNewswire/ -- Faru ...