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 ...

Group 1 - The author has a PhD in biochemistry and extensive experience analyzing clinical trials and biotech companies, emphasizing the importance of understanding the science behind investments in this sector [1] - The mission is to educate investors on conducting due diligence to avoid pitfalls in biotech investments [1] Group 2 - There is a potential for initiating a long position in URGN through stock or options purchases within the next 72 hours [2] - The article reflects the author's personal opinions and is not influenced by compensation from any company mentioned [2]

Core Viewpoint - UroGen Pharma Ltd. is under investigation for potential securities fraud and unlawful business practices, following concerns raised by the FDA regarding the clinical trial design of its bladder cancer drug UGN-102 [1][2]. 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]. - The investigation is prompted by the FDA's concerns regarding the Envision trial for UGN-102, which lacked a concurrent control arm, making the trial's primary endpoints difficult to interpret [2]. Group 2: FDA Concerns and Market Reaction - The FDA's briefing document indicated that it had recommended a randomized trial design to UroGen multiple times to address concerns about the trial's validity [2]. - Following the news of the FDA's concerns, 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 [3].

Core Insights - Holzer & Holzer, LLC is investigating UroGen Pharma Ltd. for potential compliance issues with federal securities laws following FDA comments on the company's clinical trial results [1] - The FDA indicated that the lack of a concurrent control arm in the ENVISION trial makes it difficult to interpret the primary endpoints of complete response (CR) and duration of response (DOR) [1] - UroGen's stock price experienced a decline after the FDA's statement regarding the investigational product UGN-102 [1] Company Overview - UroGen Pharma Ltd. is a publicly traded company on NASDAQ under the ticker URGN [1] - The company is involved in developing treatments for urological diseases, with a focus on innovative therapies [1] Legal Context - Holzer & Holzer, LLC is a law firm specializing in securities litigation, representing shareholders and investors in class action and derivative litigation [3] - The firm has a history of recovering significant amounts for shareholders affected by corporate misconduct [3]

Financial Data and Key Metrics Changes - UroGen reported net product revenues of $20.3 million for Q1 2025, an 8% year-over-year increase from $18.8 million in Q1 2024, driven by a 12% underlying demand growth [30][32] - The net loss for Q1 2025 was $43.8 million, or $0.92 per share, compared to a net loss of $32.3 million, or $0.87 per share, in the same period in 2024 [32] - Cash, cash equivalents, and marketable securities totaled $200.4 million as of March 31, 2025 [13][32] Business Line Data and Key Metrics Changes - Jelmyto sales for Q1 2025 were $20.3 million, reflecting an 8% year-over-year growth, with underlying demand growth of 12% [12][30] - UGN-102 is expected to target an addressable population of approximately 60,000 patients annually, translating to a market opportunity of over $5 billion, significantly larger than the Jelmyto market [11][12] Market Data and Key Metrics Changes - The company anticipates that the Medicare population will comprise about 70% of the business for UGN-102, consistent with the overall patient demographic in low-grade intermediate risk NMIBC [35] - The market for UGN-102 is expected to be more accessible, with a significant portion of patients managed by community urologists [11][12] Company Strategy and Development Direction - UroGen aims to transition from a rare disease-focused company to a multi-product team, with plans to expand the sales force from approximately 50 to over 80 representatives at the launch of UGN-102 [10][12] - The company is preparing for the potential launch of UGN-102, targeting commercial readiness by June 2025, with product availability expected in July [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming ODAC meeting and the PDUFA target date, highlighting the strength of clinical data supporting UGN-102 [16][55] - The management team emphasized the importance of addressing the unmet medical need in the recurrent low-grade intermediate risk NMIBC patient population [46][55] Other Important Information - UroGen has a strong balance sheet with over $200 million in cash and equivalents, allowing for continued investment in innovation [13][32] - The company is actively engaged in prelaunch activities for UGN-102, including educational efforts with urologists and payer engagement strategies [24][26] Q&A Session Summary Question: Breakdown of Medicare and Medicaid exposure for UGN-102 and Jelmyto - Management anticipates that the Medicare population will comprise about 70% of the business for UGN-102, with a focus on driving reimbursement confidence with providers [35] Question: Preparation for the ODAC meeting and expected pushback - Management has conducted mock ODAC panels and feels confident about presenting the clinical data, particularly addressing the single-arm study design of ENVISION [41][46] Question: Current status of the UGN-103 clinical development program - Enrollment for the UGN-103 trial is progressing ahead of plan, with top-line data anticipated in 2026 [21][71] Question: Expectations regarding the gross-to-net for Jelmyto and UGN-102 - The gross-to-net profile for Jelmyto is in the mid-70s percent, with expectations for UGN-102 to be more favorable due to a higher proportion of community-based business [101]

Financial Data and Key Metrics Changes - UroGen reported net product revenues of $20.3 million for Q1 2025, an 8% year-over-year increase from $18.8 million in Q1 2024, driven by a 12% underlying demand growth [28][30] - The net loss for Q1 2025 was $43.8 million, or $0.92 per share, compared to a net loss of $32.3 million, or $0.87 per share, in the same period in 2024 [30] - Cash, cash equivalents, and marketable securities totaled $200.4 million as of March 31, 2025 [12][30] Business Line Data and Key Metrics Changes - Jelmyto sales for Q1 2025 were $20.3 million, reflecting an 8% year-over-year growth, supported by a 12% increase in underlying demand [11][28] - UGN-102 is expected to target an addressable population of approximately 60,000 patients annually, translating to a market opportunity exceeding $5 billion, significantly larger than the Jelmyto market [10][11] Market Data and Key Metrics Changes - The company anticipates that approximately 70% of UGN-102's business will come from the Medicare population, consistent with the demographics of low-grade intermediate-risk NMIBC patients [34] - The market for UGN-102 is expected to be more accessible than the fragmented UTUC setting, as NMIBC patients are primarily managed by community urologists [10][11] Company Strategy and Development Direction - UroGen aims to transition from a rare disease-focused company to a multi-product organization, with UGN-102 as a primary growth driver alongside Jelmyto [5][9] - The company is expanding its sales force from approximately 50 to over 80 representatives in preparation for the potential launch of UGN-102 [9][24] - UroGen is committed to advancing its pipeline, including next-generation programs and immuno-oncology initiatives, while maintaining a strong balance sheet [12][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming ODAC meeting and the PDUFA target date, highlighting the strength of clinical data supporting UGN-102 [6][14] - The company is focused on ensuring timely access for patients and driving reimbursement confidence among providers [22][24] - Management emphasized the importance of UGN-102 as a transformative therapy for patients with recurrent low-grade intermediate-risk NMIBC [22][24] Other Important Information - The FDA has scheduled an ODAC meeting for UGN-102 on May 21, 2025, which is seen as a critical opportunity to present clinical data [6][10] - UroGen has engaged in extensive market research with physicians, indicating strong interest and demand for UGN-102 [55] Q&A Session Summary Question: Breakdown of Medicare and Medicaid exposure for UGN-102 and Jelmyto - Management anticipates that the Medicare population will comprise about 70% of UGN-102's business, aligning with the patient demographic for NMIBC [34] Question: Preparation for the ODAC meeting and expected pushback - Management has conducted mock ODAC panels and feels confident about presenting the clinical data, particularly addressing the single-arm study design of ENVISION [38][40] Question: Current status of the UGN-103 clinical development program - Enrollment for the UGN-103 trial is ongoing, with completion expected by mid-2025 and top-line data anticipated in 2026 [20][69] Question: Expectations regarding the gross-to-net for UGN-102 - Management expects the gross-to-net profile for UGN-102 to be more favorable than Jelmyto, primarily due to a higher proportion of community-based business [100]