Core Insights - UroGen Pharma Ltd. announced positive results from a Phase 3b study on the home administration of ZUSDURI™ (mitomycin) for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) [1][2] - The study demonstrated that trained home health professionals can safely administer ZUSDURI outside traditional clinical settings, potentially easing patient burden and reducing reliance on hospital resources [2][3] Study Findings - The study involved eight patients, with 75% completing all six scheduled treatments; 75% of patients reported a complete response rate at three months [2][4] - Patients expressed high satisfaction with the home-based treatment, with five out of six recommending it to others [2] - No new safety concerns were identified, and the safety profile was consistent with previous studies, primarily involving mild-to-moderate urinary symptoms [3][4] Treatment Administration - ZUSDURI was administered via urinary catheter once weekly for six weeks, with the first dose given in a clinic and subsequent doses at home [3] - Investigators found no significant differences in safety or efficacy between home and office administration [3] Company Overview - UroGen Pharma is focused on developing innovative treatments for urothelial and specialty cancers, utilizing proprietary RTGel technology for sustained drug release [5][8] - ZUSDURI is specifically approved for treating adults with recurrent LG-IR-NMIBC after unsuccessful bladder surgery [9] Market Context - Approximately 82,000 people in the U.S. are diagnosed with NMIBC annually, with around 59,000 experiencing recurrence [6] - The median age of diagnosis for bladder cancer is 73 years, highlighting the need for convenient treatment options for older patients [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 for treating low-grade intermediate risk non-muscle invasive bladder cancer [1][2]. Group 1: Lawsuit Details - The lawsuit covers investors who acquired UroGen securities between July 27, 2023, and May 15, 2025, with a deadline of July 28, 2025, to apply as lead plaintiff [1]. - Allegations include that UroGen's ENVISION clinical study for UGN-102 was inadequately designed, lacking a concurrent control arm, which undermined the evidence of effectiveness [3]. - The FDA had previously warned UroGen about the study design, suggesting a randomized trial, which UroGen did not conduct [4]. Group 2: Stock Price Impact - Following the FDA's briefing document on May 16, 2025, which raised concerns about the study's interpretability, UroGen's stock price fell nearly 26% [4]. - On May 21, 2025, after the Oncologic Drugs Advisory Committee voted against the approval of UGN-102, the stock price dropped nearly 45% [5].

Core Points - 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 operations [1] - The lawsuit claims that the ENVISION clinical study was inadequately designed, lacking a concurrent control arm, which raises concerns about the effectiveness of UGN-102 [1] - It is alleged that UroGen ignored FDA warnings about the study design, leading to a substantial risk that the New Drug Application (NDA) for UGN-102 would not be approved [1] - The lawsuit asserts that the positive statements made by the company regarding its business and prospects were misleading and lacked a reasonable basis [1] Legal Context - Shareholders who purchased UroGen shares between July 27, 2023, and May 15, 2025, and suffered significant losses are encouraged to discuss their legal rights [2] - The deadline for shareholders to request to be appointed as lead plaintiff in the case is July 28, 2025 [3] - Holzer & Holzer, LLC is representing the shareholders and has a history of recovering substantial amounts for investors affected by corporate misconduct [3]

Core Insights - Investing in biotechnology stocks involves long periods of inactivity followed by sharp movements, particularly in small-cap biotech stocks which often lack profitability and revenue [1][2] Group 1: Urogen Pharma - UroGen Pharma is focused on treating urologic cancers with its proprietary RTGel technology, enhancing drug efficacy by prolonging retention in the urinary tract [4] - UroGen stock has increased approximately 43% in 2025 due to an application to expand the Jelymyto label for low-grade bladder cancer, potentially increasing its market [5] - Analyst forecasts suggest a price target of $32.86 for URGN stock, indicating a potential gain of over 115% from its closing price on July 18, although short interest is high at over 42% [6] Group 2: Nektar Therapeutics - Nektar Therapeutics has seen a 78% gain in 2025 but remains down over 93% in the last five years due to several clinical trial failures [8] - Positive Phase 2b clinical trial results for a candidate treating systemic lupus erythematosus and ulcerative colitis have generated bullish sentiment, along with a Fast Track designation from the FDA [9] - The consensus price target for NKTR stock is $88.33, representing a 254% increase from its closing price on July 18, but a pullback is anticipated due to recent price surges [10] Group 3: Verve Therapeutics - Verve Therapeutics is pioneering gene editing to treat cardiovascular disease, currently in the clinical stage with revenue primarily from partnerships [12] - The company received approval for a Phase 1b U.S. clinical trial for its lead candidate, VERVE-102, targeting the PCSK9 gene associated with high cholesterol [13] - Analysts have set a price target of $14.57 for VERV stock, indicating a 33% upside, although this is lower compared to the other stocks mentioned [13]

Core Insights - UroGen Pharma Ltd. announced the publication of a five-year long-term extension study of the Phase 2b OPTIMA II trial, demonstrating durable long-term complete responses in patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) treated with ZUSDURI (mitomycin) [1][2] Company Overview - UroGen Pharma is a biotech company focused on developing innovative solutions for urothelial and specialty cancers, utilizing proprietary RTGel technology for sustained drug release [10] - ZUSDURI is specifically indicated for the treatment of adults with recurrent LG-IR-NMIBC, providing a non-surgical treatment option [5][11] Clinical Study Findings - The OPTIMA II trial included both newly diagnosed and recurrent adult patients with LG-IR-NMIBC, with 41 patients achieving complete response (CR) at three months post-treatment; 25 remained in CR at 12 months [2][4] - Among the 17 patients who entered the long-term follow-up study, the median duration of response (DOR) was 42.1 months, indicating ZUSDURI's potential for meaningful, lasting event-free periods [2][7] - The median Kaplan-Meier estimate of DOR for all 41 patients was 24.2 months, with a median follow-up of 35.8 months [2] Patient Demographics - The study cohort consisted of 17 patients, of which 16 (94%) were recurrent cases, highlighting the drug's relevance for patients facing repeated surgeries [4] Treatment Efficacy - ZUSDURI's long-term data emphasizes its ability to deliver sustained responses in an outpatient setting, which is particularly valuable for recurrent patients [2][3] - The study results reflect a commitment to providing innovative treatments that empower patients and physicians with more options [3] Safety Profile - Safety data were not collected during the long-term follow-up trial; however, the most commonly reported treatment-emergent adverse events in the parent OPTIMA II study included dysuria (41%), pollakiuria (21%), and hematuria (16%) [3][4]

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].