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 ...

Core Viewpoint - UroGen Pharma Ltd. is facing a class action lawsuit due to alleged violations of the Securities Exchange Act of 1934, with claims centered around misleading statements regarding the effectiveness of its lead product, UGN-102, and its clinical study design [1][3]. Company Overview - UroGen Pharma Ltd. specializes in developing and commercializing solutions for specialty cancers, with its primary product being UGN-102, an intravesical solution aimed at treating low-grade intermediate risk non-muscle invasive bladder cancer [2]. Allegations of the Lawsuit - The lawsuit claims that UroGen made false or misleading statements and failed to disclose critical information, including: - The ENVISION clinical study for UGN-102 was inadequately designed, lacking a concurrent control arm, which undermined its ability to demonstrate substantial evidence of effectiveness [3]. - UroGen did not adequately address FDA warnings regarding the study design for its new drug application (NDA) for UGN-102, leading to a significant risk of NDA rejection [3][4]. 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 absence 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 approval of UGN-102 on May 21, 2025, citing unfavorable benefit-risk assessment, UroGen's stock price fell nearly 45% [5]. Legal Process for Lead Plaintiff - The Private Securities Litigation Reform Act of 1995 allows any investor who purchased UroGen securities during the specified class period to seek appointment as lead plaintiff in the class action lawsuit. The lead plaintiff represents the interests of all class members [6]. Law Firm Background - Robbins Geller Rudman & Dowd LLP is a prominent law firm specializing in securities fraud and shareholder litigation, having secured over $2.5 billion for investors in 2024 alone, and is recognized for obtaining significant recoveries in securities class action cases [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 for treating low-grade intermediate risk non-muscle invasive bladder cancer [1][2]. Group 1: Allegations and FDA Concerns - The complaint alleges that UroGen failed to conduct a proper trial for UGN-102, specifically that the ENVISION clinical study lacked a concurrent control arm, making it difficult to demonstrate the drug's effectiveness [5]. - On May 16, 2025, the FDA expressed doubts about the sufficiency of the submitted data for UGN-102, stating that the lack of a concurrent control arm complicated the interpretation of primary endpoints [3]. - The FDA had previously recommended a randomized trial design multiple times during UroGen's product development, which the company did not follow [3]. Group 2: Stock Price Impact - Following the FDA's briefing document release 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 Participation - Shareholders may be eligible to participate in the class action against UroGen Pharma Ltd., with options to serve as lead plaintiff or remain an absent class member [6].

Investors can contact the law firm at no cost to learn more about recovering their losses LOS ANGELES, May 29, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises UroGen Pharma Ltd. ("UroGen " or the "Company") (NASDAQ: URGN) investors of a class action representing investors that bought securities between July 27, 2023 and May 15, 2025, inclusive (the "Class Period"). UroGen investors have until July 28, 2025 to file a lead plaintiff motion. Investors are encouraged to contact attorney Lesley F. Portnoy, ...

Core Viewpoint - UroGen Pharma Ltd. is facing a class action lawsuit due to alleged violations of the Securities Exchange Act of 1934, with claims centered around misleading statements regarding its lead product UGN-102 and its clinical study design [1][3]. Company Overview - UroGen Pharma Ltd. specializes in developing and commercializing solutions for specialty cancers, with its primary product being UGN-102, an intravesical solution aimed at treating low-grade intermediate risk non-muscle invasive bladder cancer [2]. Allegations of the Lawsuit - The lawsuit claims that UroGen made false or misleading statements and failed to disclose critical information regarding 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's challenges in demonstrating that the duration of response was attributable to UGN-102 [3]. - Ignoring FDA warnings about the study design for the new drug application (NDA) [3]. - The substantial 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 approval of UGN-102 on May 21, 2025, citing unfavorable benefit-risk assessment, UroGen's stock price fell nearly 45% [5]. Legal Process for Lead Plaintiff - The Private Securities Litigation Reform Act of 1995 allows investors who purchased UroGen securities during the class period to seek appointment as lead plaintiff, representing the interests of the class [6]. Law Firm Background - Robbins Geller Rudman & Dowd LLP is a prominent law firm specializing in securities fraud and shareholder litigation, having secured over $2.5 billion for investors in 2024 alone, and is recognized for its significant recoveries in securities class action cases [7].

URGN Investors with Losses Encouraged to Contact Hagens BermanSAN FRANCISCO, May 29, 2025 /PRNewswire/ -- On May 21, 2025, investors in UroGen Pharma Ltd. (NASDAQ: URGN) saw the price of their shares crash 44% after the company announced that the FDA's Oncologic Drugs Advisory Committee ("ODAC") voted against the risk/benefit profile of UroGen's UGN-102, a therapy intended to treat patients with low-grade, intermediate-risk non-muscle invasive bladder cancer ("LG-IR-NMIBC") for which no drugs are currently ...

UroGen Pharma (URGN) FY Conference Summary Company Overview - **Company**: UroGen Pharma (URGN) - **Event**: FY Conference held on May 28, 2025 - **Key Speakers**: Liz Barrett (President and CEO), Mark Schoenberg (CMO) Industry Context - **Industry**: Oncology, specifically focusing on treatments for non-muscle invasive bladder cancer Key Points and Arguments ODAC Meeting Insights - UroGen presented data on UGN-102 for treating grade intermediate risk non-muscle invasive bladder cancer, which was agreed upon with the FDA prior to the meeting [5][6] - The advisory committee's voting was influenced by a discussion on the necessity of randomized clinical trials, which was not directly relevant to UGN-102's approval [9][10] - The vote showed a split, with urologists supporting the approval while some medical oncologists voted against it, citing the need for randomized trials [9][47] Data Presentation - UroGen's data included efficacy and safety presentations, focusing on recurrent disease, which is a significant unmet medical need [5][6] - The FDA's inability to provide clarity on what a randomized trial would entail further complicated the discussion [10] Future Pathways - UroGen aims for approval by the PDUFA date of June 13, 2025, and is open to post-marketing commitments to demonstrate safety and efficacy [13][19] - The company is considering various scenarios, including potential commitments to randomized trials or conditional approvals [19][20][21] Regulatory Challenges - The FDA's insistence on a superiority study for UGN-102 poses challenges, as no sponsor has been required to demonstrate superiority over surgical procedures [12][25] - UroGen has already planned a five-year follow-up study (ENVISION) to gather long-term safety and efficacy data [17][19] Market Implications - The potential for a limited label could restrict UGN-102's use to specific patient populations, which may impact market reach [41][44] - Feedback from urologists indicates disappointment with the advisory committee's decision, emphasizing the need for UGN-102 in clinical practice [46][47] Patient Perspectives - Patient feedback suggests a strong preference for UGN-102 over traditional surgical options, highlighting the treatment's benefits [26][47] Additional Important Content - The discussion highlighted the complexities of demonstrating efficacy in a non-surgical context, particularly regarding endpoints in clinical trials [25][41] - The influence of Dr. Pastor, leading the oncology division at the FDA, was acknowledged, with respect for his role in ensuring effective treatments reach patients [38][39] This summary encapsulates the critical discussions and insights from the UroGen Pharma FY Conference, focusing on the regulatory landscape, clinical data, and market implications surrounding UGN-102.

Core Viewpoint - UroGen Pharma Ltd. has been downgraded from Buy to Neutral by HC Wainwright & Co. analyst Raghuram Selvaraju due to the FDA's Oncologic Drugs Advisory Committee voting 5-4 against the benefit-risk profile of its investigational therapy UGN-102 for bladder cancer [1][2]. Financial Position - UroGen concluded Q1 2025 with approximately $200 million in cash, cash equivalents, and marketable securities, which is expected to sustain operations through late 2026 even if UGN-102 fails to secure regulatory approval [4]. - The analyst forecasts a net loss of $2.14 per share for 2026, a significant change from the previous projection of earnings of 27 cents [4]. Development Pipeline - UroGen is advancing the development of UGN-103 and UGN-104, next-generation mitomycin-based formulations, which utilize the RTGel delivery platform combined with a novel mitomycin formulation licensed from medac GmbH [5]. - The Phase 3 UTOPIA trial for UGN-103 is currently enrolling patients, with enrollment expected to conclude by mid-2025 and top-line data anticipated shortly thereafter [5][6]. - If the results from UGN-103 are positive, a regulatory submission could occur in 2026, potentially leading to FDA approval by 2027 [6].

SAN FRANCISCO, May 22, 2025 (GLOBE NEWSWIRE) -- On May 21, 2025, investors in UroGen Pharma Ltd. (NASDAQ: URGN) saw the price of their shares crash 44% after the company announced that the FDA’s Oncologic Drugs Advisory Committee (“ODAC”) voted against the risk/benefit profile of UroGen’s UGN-102, a therapy intended to treat patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (“LG-IR-NMIBC”) for which no drugs are currently FDA-approved. Hagens Berman has opened an investigation in ...