SAN DIEGO, July 17, 2025 (GLOBE NEWSWIRE) -- Robbins LLP reminds stockholders that a class action was filed on behalf of investors who purchased or otherwise acquired UroGen Pharma Ltd. (NASDAQ: URGN) securities between July 27, 2023 and May 15, 2025. UroGen engages in the development and commercialization of solutions for specialty cancers. The Company’s lead pipeline product is UGN-102 (mitomycin), an intravesical solution intended to treat low-grade intermediate risk non-muscle invasive bladder cancer. F ...

Core Viewpoint - A class action lawsuit has been filed against UroGen Pharma Ltd. for alleged misleading statements regarding its lead product UGN-102, which is intended to treat low-grade intermediate risk non-muscle invasive bladder cancer [1][2][3]. Company Overview - UroGen Pharma Ltd. focuses on developing and commercializing solutions for specialty cancers, with its primary product being UGN-102, an intravesical solution for bladder cancer treatment [2]. Allegations in the Lawsuit - The lawsuit claims that UroGen made false statements and failed to disclose critical information about the ENVISION clinical study for UGN-102, including: - The study was not designed to provide substantial evidence of effectiveness due to the absence of a concurrent control arm [3]. - UroGen faced challenges in demonstrating that the duration of response was attributable to UGN-102 [3]. - The company ignored FDA warnings regarding the study design for the new drug application (NDA) [3]. - There was a significant risk that the NDA for UGN-102 would not receive approval [3]. Impact of FDA Findings - On May 16, 2025, the FDA released a briefing document indicating concerns about the ENVISION study's design, stating that the primary endpoints were difficult to interpret due to the lack of a concurrent control arm. This led to a nearly 26% drop in UroGen's stock price [4]. - Following the FDA's Oncologic Drugs Advisory Committee vote against the NDA for UGN-102 on May 21, 2025, citing unfavorable benefit-risk assessment, UroGen's stock price fell nearly 45% [5].

UroGen's Pipeline and Market Opportunity - UroGen is positioned to transform bladder cancer treatment with JELMYTO, UGN-102, and UGN-301 [3, 7] - UGN-102 may become the first FDA-approved medicine for LG-IR-NMIBC [9] - The total addressable market (TAM) for LG-IR-NMIBC is estimated to be over $5 billion [9, 120] - Approximately 82,000 patients in the U S have LG-IR-NMIBC annually [9, 120] UGN-102 Clinical Trial Results (ENVISION Study) - The complete response rate (CRR) at 3 months in the ENVISION study was 796% (191/240 patients) [44, 55, 115] - The estimated duration of response (DOR) at 12 months was 823% (N=191) [57, 70, 117] - The predicted median duration of response (DOR) is 400 months [61, 63] - The majority of adverse events (AEs) were mild to moderate in severity [64, 65] Patient Perceptions of UGN-102 vs TURBT - Interviews with 29 U S patients from the ENVISION study revealed that UGN-102 was perceived to be less invasive, painful, and time-consuming compared to TURBT [80, 86] - Patients reported that UGN-102 had less impact on daily activities and responsibilities compared to TURBT [86, 90]

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 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 concerns, UroGen's stock price dropped by $2.54, or 25.8%, closing at $7.31 per share on May 16, 2025 [3]. - After the Oncological Drugs Advisory Committee voted against the approval of UGN-102 on May 21, 2025, the stock fell by $3.37, or 44.7%, closing at $4.17 per share [4]. Group 3: Class Action Participation - Shareholders may be eligible to participate in the class action against UroGen, with a deadline to file for lead plaintiff status by July 28, 2025 [6]. - The lead plaintiff will represent other class members in directing the litigation, but participation is not required to be eligible for recovery [6].

Core Viewpoint - UroGen Pharma Ltd. is under investigation for potential securities fraud and unlawful business practices following negative FDA feedback on its bladder cancer drug UGN-102 [1][3]. Group 1: FDA Review and Trial Concerns - The FDA's briefing document highlighted that UroGen's Envision trial lacked a concurrent control arm, making the primary endpoints difficult to interpret [3]. - The FDA recommended a randomized trial design multiple times to address concerns regarding the trial's validity [3]. Group 2: Stock Price Impact - Following the FDA's briefing document release on May 16, 2025, UroGen's stock price dropped by $2.54, or 25.79%, closing at $7.31 per share [4]. - After the Oncologic Drugs Advisory Committee voted against the NDA for UGN-102 on May 21, 2025, the stock price fell further by $3.37, or 44.7%, closing at $4.17 per share [4].

Core Viewpoint - UroGen Pharma Ltd. is under investigation for potential securities fraud and unlawful business practices following negative FDA feedback on its bladder cancer drug UGN-102 [1][3]. Group 1: FDA Review and Drug Approval - The FDA's briefing document indicated that UroGen's Envision trial lacked a concurrent control arm, making the interpretation of primary endpoints challenging [3]. - The FDA recommended a randomized trial design multiple times to address concerns regarding the trial's results [3]. - On May 21, 2025, the Oncologic Drugs Advisory Committee voted against the NDA for UGN-102, citing an unfavorable benefit-risk profile for patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer [4]. Group 2: Stock Price Impact - Following the FDA's briefing document release on May 16, 2025, UroGen's stock price dropped by $2.54, or 25.79%, closing at $7.31 per share [4]. - After the advisory committee's negative vote on May 21, 2025, UroGen's stock price fell by $3.37, or 44.7%, closing at $4.17 per share [4].

Core Viewpoint - A class action securities lawsuit has been filed against UroGen Pharma Ltd. for alleged securities fraud affecting investors between July 27, 2023, and May 15, 2025 [1][2]. Group 1: Lawsuit Details - The complaint alleges that the ENVISION clinical study was inadequately designed, lacking a concurrent control arm, which undermined the effectiveness evidence for UGN-102 [2]. - It is claimed that UroGen Pharma did not heed FDA warnings regarding the study design, leading to substantial risk that the New Drug Application (NDA) for UGN-102 would not be approved [2]. - The lawsuit asserts that the defendants' positive statements about the company's business and prospects were materially misleading and lacked a reasonable basis due to these issues [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 this role [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 has a strong track record, having secured hundreds of millions for shareholders and being recognized as one of the top securities litigation firms in the U.S. for seven consecutive years [4].

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 having 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]. Legal Options for Investors - Investors who suffered losses are encouraged to submit their information to the law firm representing the class action, with representation on a contingency fee basis [7]. Law Firm Background - Bleichmar Fonti & Auld LLP is recognized as a leading international law firm in securities class actions, having achieved significant recoveries in past cases, including over $900 million from Tesla, Inc. and $420 million from Teva Pharmaceutical Industries [9].

NEW YORK, June 16, 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=152954&from=4CLASS PERIOD: July 27, 2023 to ...

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 decisions [4][5][6]. Group 1: Legal Action and Investor Information - Faruqi & Faruqi, LLP is investigating potential claims against UroGen and reminds investors of the July 28, 2025 deadline 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]. - The court-appointed lead plaintiff will represent the interests of the class and any member can move to serve as lead plaintiff [7]. Group 2: Allegations Against UroGen - The complaint alleges that UroGen and its executives violated federal securities laws by making false statements and failing to disclose critical information about the ENVISION clinical study [4]. - Specific allegations include the study's lack of a concurrent control arm, which undermined the ability to demonstrate the drug's effectiveness, and the company's disregard for FDA warnings regarding study design [4]. - As a result of these issues, there was a substantial risk that the new drug application (NDA) for UGN-102 would not be approved, leading to misleading positive statements about the company's prospects [4]. Group 3: Stock Price Impact - Following the FDA's briefing document questioning the effectiveness of UGN-102, UroGen's stock price fell by $2.54, or 25.8%, closing at $7.31 per share on May 16, 2025 [5]. - After the Oncologic Drugs Advisory Committee voted against the NDA for UGN-102, the stock price dropped by $3.37, or 44.7%, closing at $4.17 per share on May 21, 2025 [6].