Reported three-month complete response rate of 77.8% from the Phase 3 UTOPIA trial of UGN-103, consistent with ENVISION results; FDA agreed to regulatory plan to submit an NDA based on data from the UTOPIA trial ZUSDURI received unique J-Code (J9282) in October 2025, effective January 1, 2026 ZUSDURI achieved net product revenue of $1.8 million in Q3 2025; October 2025 preliminary demand revenue estimate of $4.5 million... Read More

PRINCETON, N.J., Nov. 06, 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 robust preliminary results from its ongoing Phase 3 UTOPIA trial, demonstrating a 77.8% three-month complete response (CR) rate (95% CI, 68.3%, 85.5%) with UGN-103 (mitomycin) for intravesical... Read More

PRINCETON, N.J., Nov. 04, 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 will present at the Guggenheim Securities Healthcare Innovation Conference to take place on November 10-12, 2025. Guggenheim Securities Innovation Conference Date / Time: November 11, 2025... Read More

Conference Call and Webcast Scheduled for Thursday, November 6th, 2025, at 10:00 AM ET PRINCETON, N.J., Oct. 30, 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 will report third quarter 2025 financial results on Thursday, November 6 th , 2025, prior to the open... Read More

PRINCETON, N.J., Oct. 27, 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 the Centers for Medicare and Medicaid Services (CMS) has assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II J Code, J9282, for ZUSDURI (mitomycin) for intravesical... Read More

PRINCETON, N.J., Oct. 02, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd . (Nasdaq: URGN), a biotech company focused on developing and commercializing innovative solutions for urothelial and specialty cancers, today announced the publication of a comprehensive review of the clinical development program for ZUSDURI™ (mitomycin) for intravesical solution, formerly known as UGN-102, the first and only FDA-approved medicine for... Read More

PRINCETON, N.J., Sept. 08, 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 the grants of inducement restricted stock units (“RSUs”) to 40 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of... Read More

PRINCETON, N.J., Aug. 21, 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 will participate in the following investor conferences in September. Wells Fargo Healthcare Conference Date / Time: September 3rd, at 2:15 PM ET Format: Fireside Chat Location: Boston, MA... Read More

ZUSDURI™ (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... Read More

24-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. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the 24-month DOR of 72.2% (95% CI 64.1%,... Read More

Conference 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. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will report second quarter 2025 financial results on Thursday, August 7 th , 2025, prior to the open of... Read More

PRINCETON, N.J., July 28, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative treatments for urothelial and specialty cancers, today announced the publication in Reviews in Urology of results from a Phase 3b study evaluating the feasibility of administering ZUSDURI™ (mitomycin) for intravesical solution (formerly known as UGN-102) in the home... Read More

Findings published in the journal of Clinical Genitourinary Cancer show patients remained event-free for a median of two years after achieving complete response with ZUSDURI (mitomycin) intravesical solution. Among the 17 patients who achieved complete response and entered a long-term extension study, the median duration of response was 3.5 years by Kaplan-Meier estimate. PRINCETON, N.J., July 21, 2025 (GLOBE NEWSWIRE) --... Read More

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... Read More

ZUSDURI (formerly known as UGN-102) is a localized medication designed for potent tumor ablation delivered by innovative RTGel ® technology. Approval supported by pivotal Phase 3 ENVISION trial demonstrating 78% of patients achieved complete response (CR) at 3 months, and 79% of those responders maintained complete response at 12 months after the 3-month visit (DOR). Manageable safety profile characterized primarily by mild... Read More

PRINCETON, N.J. / Jun 06, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 27 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of... Read More

PRINCETON, N.J. / Jun 02, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today highlights the presentation of the uTRACT Registry study design at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. The uTRACT Registry is a single-arm, multicenter, prospective... Read More

Presents 18-month duration of response (DOR) data from the ENVISION study Analyzes the impact of tumor burden or focality in recurrent LG-IR-NMIBC, a substudy from ENVISION Reports ENVISION and ATLAS complete response and DOR data PRINCETON, N.J. / Jun 02, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and... Read More

PRINCETON, N.J. / May 27, 2025 / Business Wire / 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 will participate in a fireside chat at the TD Cowen: 6th Annual Oncology Innovation Summit: Insights for ASCO & EHA to take place on May 27-28, 2025. TD Cowen: 6th Annual Oncology Innovation... Read More

PRINCETON, N.J. / May 21, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a leading biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, announced the outcome of today’s meeting of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA), which discussed the new drug application (NDA) for investigational... Read More

New Drug Application for UGN-102 on track for FDA-PDUFA target action date of June 13, 2025; assuming approval, commercial launch to immediately follow with product availability in July Oncologic Drugs Advisory Committee scheduled for May 21, 2025 JELMYTO ® achieved net product sales of $20.3 million in Q1 2025, compared with $18.8 million in Q1 2024, driven by underlying demand growth of 12% $200.4 million in cash, cash... Read More

PRINCETON, N.J. / May 07, 2025 / Business Wire / UroGen (NASDAQ: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the U.S. Food and Drug Administration (FDA) has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting on May 21, 2025 to review the new drug application (NDA) for UGN-102 (mitomycin) for... Read More

Conference Call and Webcast Scheduled for Monday, May 12, 2025, at 10:00 AM ET PRINCETON, N.J. / May 01, 2025 / Business Wire / 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 will report first quarter 2025 financial results on Monday, May 12, 2025, prior to the open of the stock market.... Read More

Data Presented at the 2025 American Urological Association Annual Meeting in Las Vegas, Nevada PRINCETON, N.J. / Apr 27, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today highlights a duration of response of nearly four years from a long-term follow-up study with JELMYTO ® (mitomycin) for... Read More

New analysis of patient-reported outcomes from the OPTIMA II, ATLAS and ENVISION studies of UGN-102 presented at the American Urological Association (AUA) 2025 Annual Meeting in Las Vegas, Nevada PRINCETON, N.J. / Apr 27, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced... Read More

Data Presented at the American Urological Association 2025 Annual Meeting in Las Vegas, Nevada PRINCETON, N.J. / Apr 27, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced new data from the OPTIMA II Phase 2b study of UGN‑102 (mitomycin) for intravesical solution demonstrate... Read More

18-month DOR of 80.6% by Kaplan-Meier estimate was attained in patients who achieved a complete response (CR) at three months (79.6%) Data unveiled during a Podium Presentation at the American Urological Association (AUA) 2025 Annual Meeting in Las Vegas, Nevada PRINCETON, N.J. / Apr 26, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative... Read More

UGN-301 was tolerated across all dose levels, with no dose-limiting toxicities or adverse events leading to treatment discontinuation UGN-301 formulated in a reverse thermal gel allowed sustained exposure in the bladder Some patients receiving UGN-301 (zalifrelimab) intravesical solution showed clinical activity at the week 12 disease assessment Data presented at the 2025 American Urological Association Annual Meeting in Las... Read More

18-month duration of response (DOR) data from ENVISION, and integrated patient-reported outcomes (PROs) from UGN-102-treated patients in OPTIMA II, ATLAS and ENVISION in low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) Long-term outcomes from the OPTIMA II Phase 2B study of UGN-102 Sub-analysis from a long-term follow-up study to the OLYMPUS trial of JELMYTO® (mitomycin) for pyelocalyceal solution... Read More

UGN-102 Pivotal ENVISION trial demonstrated an 18-month DOR of 80.6% (95% CI: 74.0, 85.7), by Kaplan-Meier estimate, for patients who achieved a complete response (CR) at three months after the first instillation of UGN-102 New drug application (NDA) for UGN-102 under review by the FDA; Prescription Drug User Fee Act (PDUFA) target action date set for June 13, 2025 Acquired a next-generation investigational oncolytic virus... Read More

PRINCETON, N.J. / Mar 07, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 7 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of... Read More

Conference Call and Webcast Scheduled for Monday, March 10, 2025, at 10:00 AM ET PRINCETON, N.J. / Feb 27, 2025 / Business Wire / 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 will report fourth quarter and full-year 2024 financial results on Monday, March 10, 2025, prior to the open of... Read More

PRINCETON, N.J. / Feb 24, 2025 / Business Wire / 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 will participate in a fireside chat at the TD Cowen 45 th Annual Health Care Conference to take place on March 3-5, 2025. TD Cowen 45 th Annual Health Care Conference Date / Time: March 3,... Read More

ICVB-1042 is an Oncolytic Virus Engineered to Selectively Destroy Cancer Cells While Retaining Potency and Trigger a Robust Immune Response Strategic Research Collaborations Focused on Exploring the Potential of UroGen’s Innovative RTGel ® Technology to Enhance the Clinical Effectiveness of Multiple Immunotherapies Conference Call Webcast to be Held Today at 12:00 PM ET PRINCETON, N.J. / Feb 20, 2025 / Business Wire / UroGen... Read More

Results presented at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU 2025) Treatment with UGN-102 resulted in durable complete response (CR) rates across subgroups with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) CR rates were: 82.8% for patients with a tumor burden ≤3 cm compared to 73.2% for those with a tumor burden >3 cm 79.3% for patients... Read More

PRINCETON, N.J. / Feb 12, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today highlights results from a long-term follow-up study with JELMYTO ® (mitomycin) for pyelocalyceal solution, which is FDA approved for the treatment of low-grade, upper tract urothelial cancer (LG-UTUC) in adult... Read More

PRINCETON, N.J. / Jan 30, 2025 / Business Wire / 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 will participate at the following investor conferences in February: Guggenheim Securities SMID Cap Biotech Conference Date / Time: February 5, 2025 at 10:30 AM ET Format: Presentation and 1x1... Read More

No RFS difference based on use of JELMYTO for primary chemoablation versus post-endoscopic ablation as adjuvant therapy No RFS difference based on tumor size, location, number of tumors or route of administration Maintenance treatment in a small group linked to higher RFS PRINCETON, N.J., / Jan 22, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing... Read More

ENVISION Reports 79.6% Complete Response Rate at 3 Months, 82.3% Duration of Response at 12 Months, and Consistent Safety Profile PRINCETON, N.J. / Jan 15, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the 3-month complete response (CR) rate and 12-month durability... Read More

PRINCETON, N.J. / Dec 06, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 35 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of... Read More

Favorable long-term durability data further supports JELMYTO as a primary treatment for low-grade upper tract urothelial cancer PRINCETON, N.J. / Dec 05, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today highlights results from a long-term follow-up study with JELMYTO (mitomycin) for... Read More

UGN-102 demonstrated 82.3% duration of response (DOR) at 12 months in patients who achieved complete response at 3 months 79.6% complete response rate at 3 months in patients treated with UGN-102 Safety profile consistent with prior clinical trials of UGN-102 PRINCETON, N.J. / Dec 05, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions... Read More

PRINCETON, N.J. / Dec 02, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that new data on UGN-102 (mitomycin) for intravesical solution, JELMYTO (mitomycin) for pyelocalyceal solution, and UGN-301(zalifrelimab intravesical solution) will be presented at the Society of... Read More

The Study Results are Published in the Journal of Urology Online PRINCETON, N.J. / Nov 26, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today highlights results from a long-term follow-up study with JELMYTO (mitomycin) for pyelocalyceal solution, which is FDA approved for the treatment of... Read More

New Drug Application for UGN-102 accepted by US FDA; PDUFA target action date set for June 13, 2025 JELMYTO ® achieved net product sales of $25.2 million in Q3 2024, compared to $20.9 million in Q3 2023 $254.2 million in cash, cash equivalents and marketable securities as of September 30, 2024 Conference call and webcast to be held today at 10:00 AM ET PRINCETON, N.J. / Nov 06, 2024 / Business Wire / UroGen Pharma Ltd.... Read More

Fireside Chat on November 12, 2024 at 3:00 PM ET PRINCETON, N.J. / Nov 05, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that management will participate in a fireside chat at the Guggenheim Securities Healthcare Innovation Conference to take place November 11-13, 2024.... Read More

Conference Call and Webcast Scheduled for Wednesday, November 6, 2024, at 10:00AM ET PRINCETON, N.J. / Oct 30, 2024 / Business Wire / 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 will report 2024 third quarter financial results on Wednesday, November 6, 2024, prior to the open of the... Read More

The Kaplan-Meier Estimate of Duration of Response at 12 Months in Patients Who Achieved a Complete Response at Three Months was 82.3% Patients Receiving UGN-102 had a 79.6% Complete Response Rate at Three Months Side Effect Profile Consistent with Previous Clinical Trials of UGN-102 PRINCETON, N.J, / Oct 28, 2024 / Business Wire / UroGen Pharma Ltd . (Nasdaq: URGN), a biotech company dedicated to developing and... Read More

PDUFA goal date set for June 13, 2025 UGN-102 would be the first FDA-approved medicine for LG-IR-NMIBC, if approved PRINCETON, N.J. / Oct 15, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA)... Read More

Mr. Degnan has extensive experience in financial strategy, investor relations, SEC reporting, accounting and compliance PRINCETON, N.J. / Oct 09, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that Chris Degnan has been appointed Chief Financial Officer. Mr. Degnan... Read More

Anticipated advantages of UGN-103 include a shorter manufacturing process and a simpler reconstitution procedure PRINCETON, N.J. / Oct 02, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the first patient was dosed in the Phase 3 clinical trial of investigational drug... Read More

Once issued, this patent provides U.S. intellectual property coverage of UroGen’s RTGel ® technology with medac lyophilized mitomycin formulation, covering UGN-103 and UGN-104 development programs until December 2041 PRINCETON, N.J. / Sep 16, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers,... Read More

PRINCETON, N.J. / Sep 05, 2024 / Business Wire / UroGen Pharma Ltd . (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 19 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of... Read More

H.C. Wainwright 26 th Annual Global Investment Conference 2024 Cantor Global Healthcare Conference PRINCETON, N.J. / Aug 29, 2024 / Business Wire / 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 will participate in fireside chats at the following investor conferences in September: H.C.... Read More

PRINCETON, N.J. / Aug 14, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a leading biotech company specializing in novel therapies for urothelial and specialty cancers, today announced the successful completion of its New Drug Application (NDA) submission for investigational drug UGN-102, (mitomycin) for intravesical solution, a significant step forward in potentially addressing the urgent need for innovative... Read More

Potential for an FDA decision as early as the first quarter of 2025, assuming priority review UGN-102 Phase 3 ENVISION trial demonstrated an unprecedented 82.3% Duration of Response at 12 Months by Kaplan-Meier analysis in LG-IR-NMIBC patients who achieved a complete response at three months Ended Q2 2024 with $241.3 million in cash, cash equivalents and marketable securities Reported JELMYTO ® Q2 2024 net product revenues... Read More

Conference Call and Webcast Scheduled for Tuesday, August 13, 2024, at 10:00 AM ET PRINCETON, N.J. / Aug 05, 2024 / Business Wire / 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 will report second quarter 2024 financial results on Tuesday, August 13, 2024, prior to the open of the stock... Read More

PRINCETON, N.J. / Jun 17, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the pricing of an underwritten public offering of 5,000,000 ordinary shares at a price to the public of $17.50 per ordinary share, and, to certain investors in lieu of issuing ordinary shares,... Read More

PRINCETON, N.J., June 17, 2024 (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 commenced an underwritten public offering, subject to market and other conditions, to issue and sell its ordinary shares and pre-funded warrants. In connection with the proposed... Read More

Kaplan-Meier Estimate of Duration of Response at 12 Months in Patients Who Achieved a Complete Response at Three Months was 82.3% (95% CI, 75.9%, 87.1%) Side Effect Profile Consistent with Previous Clinical Trials of UGN-102 UroGen will Host a Virtual Event Today at 11:00 AM Eastern Time PRINCETON, N.J. / Jun 13, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and... Read More

PRINCETON, N.J. / Jun 07, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) and an option (“Option”) to 15 new employees in connection with their employment with UroGen. These new team members will support the ongoing... Read More

Program to Highlight 12-Month Durability of Response Results from the Phase 3 ENVISION Pivotal Trial PRINCETON, N.J. / Jun 06, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today shared additional details about the upcoming ENVISION virtual data event on Thursday, June 13, 2024, at 11:00 a.m.... Read More

Prsentation June 11, 2024 at 3:20 PM ET PRINCETON, N.J. / Jun 05, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that management will participate in a fireside chat at the 45 th Annual Goldman Sachs Global Healthcare Conference to take place June 10-13, 2024. Goldman Sachs... Read More

PRINCETON, N.J. / Jun 03, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that David Lin will join UroGen as its Chief Commercial Officer and member of the Executive Leadership Team. In this role, David will be spearheading UroGen’s commercial strategy, including preparation for... Read More

PRINCETON, N.J. / May 22, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that management will participate in a virtual fireside chat at the TD Cowen 5 th Annual Oncology Innovation Summit on Tuesday, May 28, 2024 at 3:20 PM ET. A live webcast of the fireside chat can be... Read More

12-month duration of response data from ENVISION study of UGN-102 to be discussed during company sponsored virtual event on June 13, 2024 ENVISION data expected to support completion of UGN-102 NDA in Q3 2024 Post-hoc analysis of OLYMPUS study for JELMYTO shows disease-free periods more than 47.8 months in LG-UTUC JELMYTO ® demonstrated continued growth with net product sales of $18.8 million in Q1, compared with $17.2... Read More

Citizens JMP Life Sciences Conference H.C. Wainwright 2 nd Annual BioConnect Conference PRINCETON, N.J. / May 07, 2024 / Business Wire / 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 will present at the following investor conferences in May: Citizens JMP Life Sciences Conference – May... Read More

There Were No Differences in RFS Regarding Usage for Chemoablation or Post-Endoscopic Ablation, Tumor Size, Multifocality, or Tumor Location RFS Was 100% in Patients who Received Maintenance therapy vs 61% for Patients Who Did Not Receive Maintenance Therapy PRINCETON, N.J. / May 05, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that... Read More

New and Recurrent Patients Treated with UGN-102 Achieved Similar Durability of Response Rates (DOR) at 12 months PRINCETON, N.J / May 04, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced results from a new analysis of the ATLAS trial, which estimates using Kaplan Meier... Read More

60% Complete Response Rate after JELMYTO Induction 25% of Patients Received a Ureteral Stent PRINCETON, N.J. / May 04, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today highlights the results of a sub-analysis from a real-world patient cohort review of JELMYTO (mitomycin) for pyelocalyceal... Read More

Conference Call and Webcast Scheduled for Monday, May 13, 2024, at 10:00AM ET PRINCETON, N.J. / May 03, 2024 / Business Wire / 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 will report 2024 first quarter financial results on Monday, May 13, 2024, prior to the open of the stock market.... Read More

Subgroup analysis of the UGN-102 ATLAS Trial in patients with new versus recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) Three independent long-term real-world analyses of JELMYTO® (mitomycin) for pyelocalyceal solution exploring its use in broad patient types and method of administration PRINCETON, N.J. / Apr 17, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech... Read More

UroGen plans to initiate a Phase 3 study to explore the safety and efficacy of UGN-103 in 2024 Anticipated advantages include a new 80 mg mitomycin dosage strength that may considerably shorten the manufacturing process, simplify the reconstitution procedure, and potentially extend intellectual property protection until as late as December 2041 PRINCETON, N.J. / Apr 15, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq:... Read More

PRINCETON, N.J. / Apr 03, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging... Read More

Initiated submission of a rolling NDA to the FDA for UGN-102; 12-month duration of response data from ENVISION expected to support completion of NDA submission Announced next-generation novel mitomycin-based RTGel formulations for LG-IR-NMIBC and LG-UTUC programs from medac GmbH licensing agreement with potential IP protection until December 2041 JELMYTO ® achieved net product revenues of $82.7 million in 2023, an increase... Read More

PRINCETON, N.J. / Mar 08, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 12 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of... Read More

Conference Call and Webcast Scheduled for Thursday, March 14, 2024, at 10:00 AM ET PRINCETON, N.J. / Mar 04, 2024 / Business Wire / 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 will report fourth quarter and full-year 2023 financial results on Thursday, March 14, 2024, prior to the... Read More

Presentation March 4, 2024 at 1:30 PM ET PRINCETON, N.J. / Feb 26, 2024 / Business Wire / 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 will present at TD Cowen’s 44 th Annual Health Care Conference on Monday, March 4, 2024 at 1:30pm EST. TD Cowen 44 th Annual Health Care Conference –... Read More

Guggenheim 6th Annual Biotechnology Conference Oppenheimer 34th Annual Healthcare Life Sciences Conference PRINCETON, N.J. / Feb 01, 2024 / Business Wire / 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 will present at the following investor conferences in February: Guggenheim 6th Annual... Read More

PRINCETON, N.J. / Jan 24, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced the submission of the Chemistry, Manufacturing, and Controls (CMC) section of the New Drug Application (NDA) for UGN-102 (mitomycin) for intravesical solution to the U.S. Food and Drug Administration... Read More

PRINCETON, N.J. / Jan 17, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced a licensing agreement with medac GmbH to develop a next-generation novel mitomycin-based formulation for urothelial cancers. UGN-103, UroGen’s RTGel ® technology combined with medac’s licensed mitomycin,... Read More

Fireside Chat January 18, 2024, at 12:00 pm ET PRINCETON, N.J. / Jan 11, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that Liz Barrett, President and CEO, will participate in a fireside chat at the upcoming B. Riley Virtual Healthcare Conference on January 18 th... Read More

PRINCETON, N.J. / Dec 08, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 17 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercial launch of... Read More

Continued strong growth with JELMYTO® net product revenues of $20.9 million in Q3 2023; an increase of ~30% from the same period last year Agreement with United States Food & Drug Administration (FDA) to proceed with rolling New Drug Application (NDA) for UGN-102 beginning in January 2024 Conference call and webcast to be held today at 10:00 AM ET PRINCETON, N.J. / Nov 14, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq:... Read More

Results from the pivotal Phase 3 ENVISION trial studying primary chemoablation with UGN-102 (mitomycin) for intravesical solution in patients with recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC) will be presented as a late-breaking oral presentation The Phase 3 ATLAS trial comparing the efficacy and safety of intravesical chemoablation with UGN-102 with or without subsequent TURBT, to... Read More

Conference Call and Webcast Scheduled for Tuesday, November 14, 2023 at 10:00 AM ET PRINCETON, N.J. / Nov 07, 2023 / Business Wire / 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 will report third quarter 2023 financial results on November 14, 2023, at 8:00 AM EDT, prior to the open of... Read More

PRINCETON, N.J. / Oct 03, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on plans for submission of a New Drug Application (NDA) for UGN-102 (mitomycin) for intravesical solution. The FDA indicated... Read More

PRINCETON, N.J. / Sep 08, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 11 new employees, as well as options (“Options”) to one of the new employees, in connection with their employment with UroGen. These new... Read More

PRINCETON, N.J. / Aug 31, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it will present at the following investor conferences in September: H.C. Wainwright 25th Annual Global Investment Conference — September 11-13, 2023 Presentation: Tuesday, September 12 th at 10:00 AM... Read More

Both ENVISION and ATLAS Phase 3 trials of UGN-102 met primary endpoints in treating low-grade intermediate-risk non‐muscle‐invasive bladder cancer (LG-IR-NMIBC). Reported record JELMYTO® net product revenues in Q2 2023 of $21.1 million, an increase of ~27% from the same period last year Significantly strengthened balance sheet via $120 million private placement of ordinary shares and pre-funded warrants PRINCETON, N.J. / Aug... Read More

Phase 3 ATLAS Clinical Trial Shows UGN-102 Demonstrated Superiority to TURBT with a 55% Reduction of Risk for Recurrence, Progression or Death in Patients who Received UGN-102 PRINCETON, N.J. / Aug 08, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that The Journal of Urology... Read More

Conference Call and Webcast Scheduled for Thursday, August 10, 2023 at 10:00 AM ET PRINCETON, N.J. / Aug 02, 2023 / Business Wire / 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 will report second quarter 2023 financial results on Thursday, August 10, 2023, prior to the open of the... Read More

PRINCETON, N.J. / Jul 31, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN) a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) and options (“Options”) to a new employee, Michael Louie, SVP Medical Affairs & Clinical Development, in connection with his commencing... Read More

PRINCETON, N.J. / Jul 27, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN) (UroGen), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it has entered into a definitive securities purchase agreement in connection with a private placement (the Private Placement) to selected institutional and accredited investors. RA... Read More

In ATLAS, UGN-102 Demonstrated Superiority to TURBT with a 55% Reduction of Risk for Recurrence, Progression or Death in Patients who Received UGN-102 ENVISION Showed a Complete Response Rate of 79.2% at 3-Months Side Effect Profile in ATLAS and ENVISION Consistent with Previous Clinical Trials of UGN-102 UroGen Will Review ATLAS and ENVISION Top-line Data Today at 10:00 a.m. Eastern Time PRINCETON, N.J. / Jul 27, 2023 /... Read More

PRINCETON, N.J. / Jul 25, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced the appointment of James Robinson, former President and Chief Executive Officer (CEO) of Urovant Sciences, to its Board of Directors, effective immediately. “We are thrilled to welcome Jim to the Board of... Read More

PRINCETON, N.J. / Jul 10, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today highlights the results of a sub-analysis from the first post-commercial utilization review of JELMYTO (mitomycin) for pyelocalyceal solution. This study assessed the efficacy of JELMYTO in managing patients... Read More

Program to Highlight Topline Results from the Phase 3 ATLAS and Pivotal ENVISION Clinical Trials PRINCETON, N.J. / Jul 06, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it will host a data event on Thursday, July 27th, 2023 at 10:00 a.m. Eastern Time. The event will focus... Read More

PRINCETON, N.J. / Jun 20, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today highlights the results of a sub-analysis from the first post-commercial utilization review of JELMYTO ® (mitomycin) for pyelocalyceal solution. This is the first study to compare modes of administration for... Read More

PRINCETON, N.J. / Jun 09, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 6 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercial launch of... Read More

PRINCETON, N.J. / Jun 02, 2023 / Business Wire / 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 will present at the following investor conferences in June: Jefferies 2023 Healthcare Conference — June 7-9, 2023 Fireside Chat Date: Friday, June 9 th from 12:45-1:10pm ET Webcast Link:... Read More

Reported JELMYTO ® Q1 2023 net product revenues of $17.2 million, an increase of ~27% from Q1 2022 Complete Response data from ENVISION pivotal trial and topline data readout from ATLAS trial on track for summer 2023 PRINCETON, N.J. / May 11, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers,... Read More

Conference Call and Webcast Scheduled for Thursday, May 11, 2023, at 10:00 AM ET PRINCETON, N.J. / May 04, 2023 / Business Wire / 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 will report 2023 first quarter financial results on Thursday, May 11, 2023, prior to the open of the stock... Read More

New Retrospective Study Presented at AUA 2023 Reports Use of JELMYTO in Treating Patients with Upper Tract Urothelial Cancer After Complete Endoscopic Ablation PRINCETON, N.J. / May 01, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today highlights the results of a sub-analysis from the... Read More

PRINCTON, N.J. / Apr 30, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today highlights the results of a sub-analysis from the first and largest post-commercial utilization review of JELMYTO ® (mitomycin) for pyelocalyceal solution presented at the American Urological Association Meeting... Read More

Fireside Chat May 2, 2023 from 10:00 – 10:30 AM ET PRINCETON, N.J. / Apr 25, 2023 / Business Wire / 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 will participate in a fireside chat at the upcoming H.C. Wainwright BioConnect Conference on May 2, 2023 at 10:00 AM ET. A live audio webcast... Read More

PRINCETON, N.J. / Mar 09, 2023 / Business Wire / 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 will report fourth quarter and full-year 2022 financial results on Thursday, March 16, 2023, prior to the open of the stock market. The announcement will be followed by a live audio webcast... Read More

PRINCETON, N.J. / Mar 06, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN) a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 7 new employees in connection with their entering into employment with UroGen. The grants were made between March 1, 2023 and March 6, 2023.... Read More

PRINCETON, N.J. / Mar 01, 2023 / Business Wire / 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 will present at the following investor conferences in March: Cowen 43 rd Annual Health Care Conference — March 7-9, 2023 Panel Presentation Date: Tuesday, March 7 th from 12:50-1:50pm ET... Read More

PRINCETON, N.J. / Feb 15, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced preliminary results of a study to assess the feasibility of home instillation of UGN-102 (mitomycin) for intravesical solution, an investigational therapy in development for primary chemoablation of... Read More

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today highlights results from the first and largest post-commercial utilization review of JELMYTO ® (mitomycin) for pyelocalyceal solution. This study evaluated 132 patients treated with JELMYTO from 15 high-volume academic and community centers and characterizes... Read More

Results from this ongoing, non-interventional, rollover study were presented at the 23 rd Annual Society of Urologic Oncology (SUO) Meeting in San Diego SAN DIEGO--( BUSINESS WIRE )-- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to creating novel solutions that treat urothelial and specialty cancers, today announced new data from the OLYMPUS registration trial designed to obtain long-term follow-up data on... Read More