UroGen Pharma Ltd. (URGN)
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UroGen Pharma Ltd., a biotechnology company, engages in the development and commercialization novel solutions for specialty cancers and urothelial diseases. It offers RTGel, a polymeric biocompatible and reverse thermal gelation hydrogel to improve therapeutic profiles of existing drugs; and Jelmyto for pyelocalyceal solution. The company's lead product candidate is UGN-102, which is in Phase III clinical trials for the treatment of several forms of non-muscle invasive urothelial cancer that include low-grade upper tract urothelial carcinoma and low-grade non-muscle invasive bladder cancer. It is also developing UGN-301 for the treatment of high-grade non-muscle invasive bladder cancer. The company has a license agreement with Allergan Pharmaceuticals International Limited for developing and commercializing pharmaceutical products that contain RTGel and clostridial toxins; Agenus Inc. to develop, make, use, sell, import, and commercialize products of Agenus for the treatment of cancers of the urinary tract via intravesical delivery; and strategic research collaboration with MD Anderson to advance investigational treatment for high-grade bladder cancer. UroGen Pharma Ltd. was incorporated in 2004 and is based in Princeton, New Jersey.
NEWS

ZUSDURI™ Clinical Review Published in Reviews in Urology™ Highlights Durable Efficacy and Manageable Safety Profile in Recurrent Low-Grade, Intermediate-Risk Non–Muscle Invasive Bladder Cancer
globenewswire.com
2025-10-02 08:00:00PRINCETON, N.J., Oct. 02, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.

UroGen Pharma to Present at Upcoming Investor Conferences
globenewswire.com
2025-08-21 08:00:00PRINCETON, N.J., Aug. 21, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.

Piper starts 'underestimated' UroGen Pharma with an Overweight
https://thefly.com
2025-08-19 06:27:37As previously reported, Piper Sandler initiated coverage of UroGen Pharma with an Overweight rating and $36 price target. Investors are starting to gain more confidence in the Zusduri launch, but the firm thinks the Street still underestimates peak sales potential in LG-IR-NMIBC and overestimates intellectual property risk to the -102/-103 franchise, the analyst contends. The firm sees early commercial launch datapoints, combined with updates from the Phase 3 UTOPIA trial of UGN-103, driving "meaningful upside" over the next 12-18 months. 26 Aug

UroGen Pharma: Targeting Profits In 2027
seekingalpha.com
2025-08-18 15:34:11UroGen Pharma Ltd. recently secured FDA approval for Zusduri, its second commercial product, which is expected to significantly boost future revenues. Analysts remain bullish, with multiple Buy ratings and price targets between $31 and $47, reflecting optimism about the company's growth trajectory. Despite growing sales, UroGen continues to post net losses and will likely require a capital raise to support the Zusduri launch.

UroGen Pharma Ltd. (URGN) Q2 2025 Earnings Call Transcript
seekingalpha.com
2025-08-09 03:05:02UroGen Pharma Ltd. (NASDAQ:URGN ) Q2 2025 Earnings Conference Call August 7, 2025 10:00 AM ET Company Participants Christopher Degnan - Chief Financial Officer David Lin - Chief Commercial Officer Elizabeth A.

Urogen Pharma (URGN) Reports Q2 Loss, Lags Revenue Estimates
zacks.com
2025-08-07 10:16:04Urogen Pharma (URGN) came out with a quarterly loss of $1.05 per share versus the Zacks Consensus Estimate of a loss of $0.82. This compares to a loss of $0.91 per share a year ago.

UroGen Pharma Expands Commercial Portfolio with Launch of ZUSDURI™ and Reports Second Quarter 2025 Financial Results
globenewswire.com
2025-08-07 08:00:00ZUSDURI™ (mitomycin) for intravesical solution now available as the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) JELMYTO® achieved net product sales of $24.2 million in Q2 2025, compared with $21.8 million in Q2 2024, representing 11% year-over-year growth $161.6 million in cash, cash equivalents and marketable securities as of June 30, 2025 Conference call and webcast to be held today at 10:00 AM ET PRINCETON, N.J., Aug. 07, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.

UroGen Announces 24-Month Duration of Response of 72.2% from the Pivotal Phase 3 ENVISION Trial of ZUSDURI, the First and Only FDA-Approved Medicine for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
globenewswire.com
2025-08-05 08:00:0024-month Duration of Response (DOR) of 72.2% by Kaplan-Meier estimate was attained in patients who achieved a complete response (CR) at three months (79.6%) PRINCETON, N.J., Aug. 05, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.

UroGen Pharma to Report Second Quarter 2025 Financial Results on Thursday, August 7th, 2025
globenewswire.com
2025-07-29 08:00:00Conference Call and Webcast Scheduled for Thursday, August 7 th , 2025, at 10:00 AM ET PRINCETON, N.J., July 29, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.

UROGEN FINAL DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds UroGen Pharma (URGN) Investors of the July 28th Deadline and Urges Investors in to Inquire About Their Rights in Class Action Lawsuit
globenewswire.com
2025-07-28 10:45:00Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In UroGen Pharma (URGN) To Contact Him Directly To Discuss Their Options

UroGen Announces Publication of Phase 3b Study Results Demonstrating the Feasibility of Home Instillation of ZUSDURI™ for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer in Reviews in Urology
globenewswire.com
2025-07-28 08:00:00PRINCETON, N.J., July 28, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.

UROGEN DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds UroGen Pharma (URGN) Investors of the July 28th Deadline and Urges Investors to Inquire About Their Rights in Class Action Lawsuit
globenewswire.com
2025-07-21 19:39:00Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In UroGen Pharma (URGN) To Contact Him Directly To Discuss Their Options

INVESTOR ALERT: Holzer & Holzer, LLC Reminds Investors of July 28, 2025 Lead Plaintiff Deadline in the UroGen Pharma Ltd. (URGN) Class Action – Investors With Significant Losses Encouraged to Contact the Firm
globenewswire.com
2025-07-21 14:11:00ATLANTA, July 21, 2025 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against UroGen Pharma Ltd. (“UroGen” or the “Company”) (NASDAQ: URGN). The lawsuit alleges that Defendants made materially false and/or misleading statements and/or failed to disclose material adverse information about UroGen's business, operations, and prospects, including allegations that: (1) the ENVISION clinical study was not designed to demonstrate substantial evidence of effectiveness of UGN-102 because it lacked a concurrent control arm; (2) as a result, the Company would have difficulty demonstrating that the duration of response endpoint was attributable to UGN-102; (3) UroGen failed to heed the FDA's warnings about the study design used to support a drug application for UGN-102; (4) as a result of the foregoing, there was a substantial risk that the NDA for UGN-102 would not be approved; and (5) as a result of the foregoing, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

3 Bullish Biotech Stocks With Explosive Growth Trends
marketbeat.com
2025-07-21 11:03:04Investing in biotechnology stocks is similar to the drug development process itself. That is, investors frequently experience long periods of nothing much happening, interrupted by periods of sharp movement.

UroGen Announces Five-Year Long-Term Extension Study of the OPTIMA II Trial Demonstrates Long-Term Durability of Response to ZUSDURI™ in Patients with Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
globenewswire.com
2025-07-21 08:00:00PRINCETON, N.J., July 21, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions for urothelial and specialty cancers, today announced the publication of results of a five-year long-term extension study of the Phase 2b OPTIMA II trial evaluating ZUSDURI (mitomycin) for intravesical solution in patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) demonstrating durable, long-term complete responses (CRs) in patients who initially achieved a CR following treatment with ZUSDURI. The publication, titled “Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer With UGN-102: Outcomes From the 5-year Long-Term Extension Study of the Single-Arm, Phase 2b OPTIMA II Study”, is now available online at https://doi.org/10.1016/j.clgc.2025.102392.
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ZUSDURI™ Clinical Review Published in Reviews in Urology™ Highlights Durable Efficacy and Manageable Safety Profile in Recurrent Low-Grade, Intermediate-Risk Non–Muscle Invasive Bladder Cancer
globenewswire.com
2025-10-02 08:00:00PRINCETON, N.J., Oct. 02, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.

UroGen Pharma to Present at Upcoming Investor Conferences
globenewswire.com
2025-08-21 08:00:00PRINCETON, N.J., Aug. 21, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.

Piper starts 'underestimated' UroGen Pharma with an Overweight
https://thefly.com
2025-08-19 06:27:37As previously reported, Piper Sandler initiated coverage of UroGen Pharma with an Overweight rating and $36 price target. Investors are starting to gain more confidence in the Zusduri launch, but the firm thinks the Street still underestimates peak sales potential in LG-IR-NMIBC and overestimates intellectual property risk to the -102/-103 franchise, the analyst contends. The firm sees early commercial launch datapoints, combined with updates from the Phase 3 UTOPIA trial of UGN-103, driving "meaningful upside" over the next 12-18 months. 26 Aug

UroGen Pharma: Targeting Profits In 2027
seekingalpha.com
2025-08-18 15:34:11UroGen Pharma Ltd. recently secured FDA approval for Zusduri, its second commercial product, which is expected to significantly boost future revenues. Analysts remain bullish, with multiple Buy ratings and price targets between $31 and $47, reflecting optimism about the company's growth trajectory. Despite growing sales, UroGen continues to post net losses and will likely require a capital raise to support the Zusduri launch.

UroGen Pharma Ltd. (URGN) Q2 2025 Earnings Call Transcript
seekingalpha.com
2025-08-09 03:05:02UroGen Pharma Ltd. (NASDAQ:URGN ) Q2 2025 Earnings Conference Call August 7, 2025 10:00 AM ET Company Participants Christopher Degnan - Chief Financial Officer David Lin - Chief Commercial Officer Elizabeth A.

Urogen Pharma (URGN) Reports Q2 Loss, Lags Revenue Estimates
zacks.com
2025-08-07 10:16:04Urogen Pharma (URGN) came out with a quarterly loss of $1.05 per share versus the Zacks Consensus Estimate of a loss of $0.82. This compares to a loss of $0.91 per share a year ago.

UroGen Pharma Expands Commercial Portfolio with Launch of ZUSDURI™ and Reports Second Quarter 2025 Financial Results
globenewswire.com
2025-08-07 08:00:00ZUSDURI™ (mitomycin) for intravesical solution now available as the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) JELMYTO® achieved net product sales of $24.2 million in Q2 2025, compared with $21.8 million in Q2 2024, representing 11% year-over-year growth $161.6 million in cash, cash equivalents and marketable securities as of June 30, 2025 Conference call and webcast to be held today at 10:00 AM ET PRINCETON, N.J., Aug. 07, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.

UroGen Announces 24-Month Duration of Response of 72.2% from the Pivotal Phase 3 ENVISION Trial of ZUSDURI, the First and Only FDA-Approved Medicine for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
globenewswire.com
2025-08-05 08:00:0024-month Duration of Response (DOR) of 72.2% by Kaplan-Meier estimate was attained in patients who achieved a complete response (CR) at three months (79.6%) PRINCETON, N.J., Aug. 05, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.

UroGen Pharma to Report Second Quarter 2025 Financial Results on Thursday, August 7th, 2025
globenewswire.com
2025-07-29 08:00:00Conference Call and Webcast Scheduled for Thursday, August 7 th , 2025, at 10:00 AM ET PRINCETON, N.J., July 29, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.

UROGEN FINAL DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds UroGen Pharma (URGN) Investors of the July 28th Deadline and Urges Investors in to Inquire About Their Rights in Class Action Lawsuit
globenewswire.com
2025-07-28 10:45:00Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In UroGen Pharma (URGN) To Contact Him Directly To Discuss Their Options

UroGen Announces Publication of Phase 3b Study Results Demonstrating the Feasibility of Home Instillation of ZUSDURI™ for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer in Reviews in Urology
globenewswire.com
2025-07-28 08:00:00PRINCETON, N.J., July 28, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.

UROGEN DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds UroGen Pharma (URGN) Investors of the July 28th Deadline and Urges Investors to Inquire About Their Rights in Class Action Lawsuit
globenewswire.com
2025-07-21 19:39:00Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In UroGen Pharma (URGN) To Contact Him Directly To Discuss Their Options

INVESTOR ALERT: Holzer & Holzer, LLC Reminds Investors of July 28, 2025 Lead Plaintiff Deadline in the UroGen Pharma Ltd. (URGN) Class Action – Investors With Significant Losses Encouraged to Contact the Firm
globenewswire.com
2025-07-21 14:11:00ATLANTA, July 21, 2025 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against UroGen Pharma Ltd. (“UroGen” or the “Company”) (NASDAQ: URGN). The lawsuit alleges that Defendants made materially false and/or misleading statements and/or failed to disclose material adverse information about UroGen's business, operations, and prospects, including allegations that: (1) the ENVISION clinical study was not designed to demonstrate substantial evidence of effectiveness of UGN-102 because it lacked a concurrent control arm; (2) as a result, the Company would have difficulty demonstrating that the duration of response endpoint was attributable to UGN-102; (3) UroGen failed to heed the FDA's warnings about the study design used to support a drug application for UGN-102; (4) as a result of the foregoing, there was a substantial risk that the NDA for UGN-102 would not be approved; and (5) as a result of the foregoing, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

3 Bullish Biotech Stocks With Explosive Growth Trends
marketbeat.com
2025-07-21 11:03:04Investing in biotechnology stocks is similar to the drug development process itself. That is, investors frequently experience long periods of nothing much happening, interrupted by periods of sharp movement.

UroGen Announces Five-Year Long-Term Extension Study of the OPTIMA II Trial Demonstrates Long-Term Durability of Response to ZUSDURI™ in Patients with Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
globenewswire.com
2025-07-21 08:00:00PRINCETON, N.J., July 21, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions for urothelial and specialty cancers, today announced the publication of results of a five-year long-term extension study of the Phase 2b OPTIMA II trial evaluating ZUSDURI (mitomycin) for intravesical solution in patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) demonstrating durable, long-term complete responses (CRs) in patients who initially achieved a CR following treatment with ZUSDURI. The publication, titled “Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer With UGN-102: Outcomes From the 5-year Long-Term Extension Study of the Single-Arm, Phase 2b OPTIMA II Study”, is now available online at https://doi.org/10.1016/j.clgc.2025.102392.