UroGen Pharma Ltd., a biopharmaceutical company, engages in the development and commercialization novel solutions for specialty cancers and urologic 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-302 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. It also has a strategic research agreement with the Johns Hopkins University to explore the potential of checkpoint inhibitors combined with RTGel in glioblastoma multiform. UroGen Pharma Ltd. was incorporated in 2004 and is based in Princeton, New Jersey.
IPO Year: 2017
Exchange: NASDAQ
Website: urogen.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 6/16/2025 | $50.00 | Neutral → Buy | H.C. Wainwright |
| 5/22/2025 | Buy → Neutral | H.C. Wainwright | |
| 4/16/2025 | $23.00 | Sector Outperform | Scotiabank |
| 2/19/2025 | $31.00 | Buy | Ladenburg Thalmann |
| 8/22/2024 | $40.00 | Buy | Guggenheim |
| 2/8/2023 | $35.00 → $10.00 | Buy → Hold | Jefferies |
| 4/27/2022 | $20.00 | Buy | Berenberg |
| 1/18/2022 | $50.00 → $34.00 | Buy | HC Wainwright & Co. |
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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 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. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and spec
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%, 78.8%) by Kaplan-Meier estimate in patients who achieved CR at three months from the Phase 3 ENVISION trial of ZUSDURI™ (mitomycin) for intravesical solution, a treatment for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NM
Conference Call and Webcast Scheduled for Thursday, August 7th, 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 7th, 2025, prior to the open of the stock market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time. A live public webcast of the earnings conference call can be accessed on UroGen's Investor Relations website. Following the live webcast, a replay wil
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 setting. The study, titled "Home Instillation of UGN-102 for Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer: A Single-Arm, Open-Label, Phase 3b Trial," demonstrated that trained home health professionals (HHPs) can safely
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) -- 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
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). The UTOPIA trial enrolled 99 patients across multiple centers globally. UGN-103 uses UroGen's proprietary sustained release RTGel® technology, a reverse-thermal hydrogel that enables sus
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 to moderate lower urinary tract symptoms. An estimated 59,000 LG-IR-NMIBC patients in the U.S. recur each year and face repeat surgeries. Conference call and webcast to be held on June 13, 2025, at 8:30 AM ET UroGen Pharma Ltd. (NASDAQ:URGN), a biotech com
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 Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen's first approved product, and the continued development of the Company's pipeline. Up to 118,000 ordinary shares of UroGen are issuable upon the vesting and settlement of the RSUs. The RSUs will vest equally over three years, with one-third of the underlying shares ve
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 and retrospective study evaluating the real-world use of JELMYTO® (mitomycin) for pyelocalyceal solution for the treatment of adult patients with low-grade upper tract urothelial carcinoma (LG-UTUC) across the United States. "By capturing these real-world insights, the uTRACT Registry will inform best practices in the
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 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 the ENVISION and ATLAS clinical studies exploring investigational therapy UGN-102 (mitomycin) for intravesical solution for the treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The data are featured at the 2025 American Society
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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 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. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and spec
Conference Call and Webcast Scheduled for Thursday, August 7th, 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 7th, 2025, prior to the open of the stock market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time. A live public webcast of the earnings conference call can be accessed on UroGen's Investor Relations website. Following the live webcast, a replay wil
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 to moderate lower urinary tract symptoms. An estimated 59,000 LG-IR-NMIBC patients in the U.S. recur each year and face repeat surgeries. Conference call and webcast to be held on June 13, 2025, at 8:30 AM ET UroGen Pharma Ltd. (NASDAQ:URGN), a biotech com
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 equivalents and marketable securities as of March 31, 2025 Conference call and webcast to be held today at 10:00 AM ET UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and sp
Conference Call and Webcast Scheduled for Monday, May 12, 2025, at 10:00 AM ET 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. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time. A live public webcast of the earnings conference call can be accessed on UroGen's Investor Relations website. Following the live webcast, a replay will be available on the site for approximately 30 days. About UroG
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 (ICVB-1042) and announced multiple strategic research collaborations in support of long-term growth strategy JELMYTO® achieved net product revenue of $90.4 million in 2024, compared with $82.7 million in 2023, driven by underlying demand revenue growth of 12% for 2
Conference Call and Webcast Scheduled for Monday, March 10, 2025, at 10:00 AM ET 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 the stock market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time. A live public webcast of the earnings conference call can be accessed on UroGen's Investor Relations website. Following the live webcast, a replay will be available on the site for approximately
- 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 UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced expansion of its oncology pipeline portfolio through the acquisition of assets relating to a next-generation oncolytic virus ICVB-1042 from
Conference Call and Webcast Scheduled for Wednesday, November 6, 2024, at 10:00AM ET 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 stock market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time. A live public webcast of the earnings conference call can be accessed on UroGen's Investor Relations website. Following the live webcast, a replay will be available on the site for approximately 30 days
Conference Call and Webcast Scheduled for Tuesday, August 13, 2024, at 10:00 AM ET 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 market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time. A live public webcast of the earnings conference call can be accessed on UroGen's Investor Relations website. Following the live webcast, a replay will be available on the site for approximately 30 days.
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H.C. Wainwright upgraded UroGen Pharma from Neutral to Buy and set a new price target of $50.00
H.C. Wainwright downgraded UroGen Pharma from Buy to Neutral
Scotiabank initiated coverage of UroGen Pharma with a rating of Sector Outperform and set a new price target of $23.00
Ladenburg Thalmann resumed coverage of UroGen Pharma with a rating of Buy and set a new price target of $31.00
Guggenheim initiated coverage of UroGen Pharma with a rating of Buy and set a new price target of $40.00
Jefferies downgraded UroGen Pharma from Buy to Hold and set a new price target of $10.00 from $35.00 previously
Berenberg initiated coverage of UroGen Pharma with a rating of Buy and set a new price target of $20.00
HC Wainwright & Co. reiterated coverage of UroGen Pharma with a rating of Buy and set a new price target of $34.00 from $50.00 previously
HC Wainwright & Co. reiterated coverage of UroGen Pharma with a rating of Buy and set a new price target of $50.00 from $57.00 previously
HC Wainwright resumed coverage of UroGen Pharma with a rating of Buy
Live Leadership Updates
Mr. Degnan has extensive experience in financial strategy, investor relations, SEC reporting, accounting and compliance 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 succeeds Don Kim, who is leaving UroGen to pursue other opportunities. "Under Don's financial stewardship, we have strengthened our financial position and achieved significant milestones, which include multiple capital raises and investing in the potential commercial launch of UGN-102 for low-grade intermediate-risk non-musc
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 the potential launch of our lead pipeline candidate UGN-102, if approved, and driving the continued growth and commercialization of JELMYTO® (mitomycin) for pyelocalyceal solution. David Lin brings to UroGen a wealth of experience garnered from a distinguished career in the pharmaceutical industry. Prior to joining U
NorthStar Medical Technologies, LLC, parent company of NorthStar Medical Radioisotopes, LLC, a global innovator in development, production and commercialization of radiopharmaceuticals used to detect and treat cancer and other serious diseases, today announced the appointment of Peter (Pete) Pfreundschuh to its Board of Managers, effective April 1, 2024. Following this appointment, the Board will comprise of 9 directors, 6 of whom are non-executive. "We are pleased to welcome Pete to the NorthStar Board," said Stephen Merrick, Executive Chairman of NorthStar. "Pete has deep experience in the pharmaceutical and biotechnology industry, with extensive knowledge in corporate finance, business
IRVINE, Calif., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. ("Eledon") (NASDAQ:ELDN) today announced the appointment of James Robinson to its Board of Directors effective October 1, 2023. Mr. Robinson is a seasoned biopharmaceutical executive with over 30 years of experience in the industry, most recently serving as Chief Executive Officer and Director of Urovant Sciences until its merger with Sumitomo Pharma America on July 1, 2023. "I am pleased to welcome Jim to our Board and look forward to working with him," said David-Alexandre C. Gros, M.D., Chief Executive Officer. "Jim joins our Board at a pivotal time in our mission to bring a novel and much-needed new treatm
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 Directors," said Liz Barrett, President and Chief Executive Officer of UroGen. "His proven leadership, operational and commercial experience will provide valuable guidance as we look to expand access to JELMYTO and advance our lead clinical development program, UGN-102 in low-grade intermediate risk bladder cancer, to
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 Dan Wildman to its Board of Directors, effective immediately. Dan Wildman, Chairman of the Board of Progenerative Medical, Inc., a 40-year veteran of the medical device industry, and Strategic Advisor to several medical device and pharmaceutical companies, has agreed to join UroGen's board, effective immediately. Dan spent most of his career with Johnson & Johnson, where he most recently led the Digital Surgery Strategy Initiative that developed an integrated strategy for robotic surgery for the Compa
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 Dr. Leana S. Wen to its Board of Directors, effective immediately. Dr. Leana S. Wen, an emergency medicine physician and public health and policy expert, has agreed to join UroGen's board, effective immediately. She has served as a professor of health policy and management at the George Washington University School of Public Health since September 2019. "We are fortunate to welcome Dr. Wen to UroGen's Board of Directors," said Liz Barrett, President and Chief Executive Officer, UroGen. "Dr. Wen's wor
FLORHAM PARK, N.J., March 22, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced the appointment of Molly Henderson to the position of Chief Financial and Business Officer. Ms. Henderson will join the Company effective April 5, 2022. Ms. Henderson most recently served as Chief Financial Officer of UroGen Pharma (NASDAQ:URGN), a commercial-stage biopharmaceutical company focused on building novel treatments for specialty cancers and urologic disease. She brings over two decades of global finance expertise and has
PRINCETON, N.J. & HOUSTON--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, and The University of Texas MD Anderson Cancer Center today announced a strategic three-year collaboration agreement to advance combinatorial intravesical immunotherapy, which is delivered directly into the bladder, for the treatment of high-grade non-muscle invasive bladder cancer (HG-NMIBC). UroGen’s approach involves the local delivery of potent immunomodulators (UGN-201, a TLR 7/8 agonist and UGN-301, an anti-CTLA-4 antibody). UGN-301, an immune checkpoint inhibitor
PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN) a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced the presentation of final data from the UGN-101 Jelmyto® (mitomycin) for pyelocalyceal solution Phase 3 OLYMPUS trial in patients with low-grade upper tract urothelial cancer (LG-UTUC). The results will be presented as a virtual podium presentation at the 21st Annual Meeting of the Society of Urologic Oncology (SUO): Oral Session: Best of Bladder Cancer Abstract #: 1003 Title: Durability of Response to Chemoablative Treatment of Low-Grade Upper Tract Urotheli