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 the FDA expressed doubts about the effectiveness of UGN-102 due to the lack of a concurrent control arm in the ENVISION clinical study, making the primary endpoints difficult to interpret [3]. - The FDA had recommended a randomized trial design multiple times during UroGen's product development, but the company chose not to follow this advice [3]. - Following the FDA's briefing document, UroGen's stock price fell by $2.54, or 25.8%, closing at $7.31 per share on May 16, 2025 [3]. Group 2: Advisory Committee Vote and Stock Impact - On May 21, 2025, the Oncological Drugs Advisory Committee voted against the approval of UGN-102, citing an unfavorable benefit-risk profile for patients [4]. - This negative vote led to a significant drop in UroGen's stock price, which fell by $3.37, or 44.7%, closing at $4.17 per share on the same day [4]. Group 3: Class Action Participation - Shareholders interested in participating in the class action must file their motion for lead plaintiff by July 28, 2025, with the lead plaintiff representing other class members in the litigation [6]. - Shareholders can choose to remain absent class members without participating in the case [6].

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]

PRINCETON, N.J., July 07, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it has completed patient enrollment in its Phase 3 UTOPIA clinical trial of UGN- 103 (mitomycin) for intravesical solution, a next-generation formulation in development for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ...

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].

Core Viewpoint - UroGen Pharma Ltd. is facing allegations related to misleading statements about its lead pipeline product, UGN-102, during the class period from July 27, 2023, to May 15, 2025, which may impact the company's stock and investor confidence [2]. Group 1: Allegations and Legal Context - The complaint alleges that the ENVISION clinical study was not designed to provide substantial evidence of UGN-102's effectiveness due to the absence of a concurrent control arm [2] - UroGen is accused of failing to heed FDA warnings regarding the study design, which raises concerns about the approval of the New Drug Application (NDA) for UGN-102 [2] - The allegations suggest that the company's positive statements about its business and prospects were materially misleading and lacked a reasonable basis [2] Group 2: Shareholder Actions and Deadlines - Shareholders who purchased URGN shares during the specified class period are encouraged to register for potential lead plaintiff appointment, with a deadline set for July 28, 2025 [3] - Once registered, shareholders will be enrolled in a portfolio monitoring system to receive updates on the case's progress [3] - There is no cost or obligation for shareholders to participate in this class action [3] Group 3: Law Firm's Role - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and illegal business practices [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]