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

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 Summit: Insights for ASCO & EHA Date / Time: May 28, 2025, at 9:00 AM ET Format: Fireside Chat Location: Virtual Webcast Link: here Webcasts from the conferences will also be available on UroGen's Investor Relations website. A replay will be available on th

  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 drug UGN-102 (mitomycin) for intravesical solution. By a narrow margin, the ODAC voted 4 to 5 that the benefit/risk of UGN-102 (mitomycin) for intravesical solution was favorable for the treatment of recurrent LG-IR-NMIBC. "While we are disappointed by today's outcome, we continue to believe our clinical data support U

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

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 intravesical solution, an investigational treatment for recurrent LG-IR-NMIBC. The ODAC meeting will provide an opportunity for independent clinicians and other experts to evaluate the UGN-102 data and make a recommendation to the FDA as to whether the NDA should be approved and under what conditions. The FDA carefully considers

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

Data Presented at the 2025 American Urological Association Annual Meeting in Las Vegas, Nevada 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 pyelocalyceal solution, which is FDA-approved for the treatment of low-grade upper tract urothelial cancer (LG-UTUC) in adult patients. Among patients from the OLYMPUS trial who achieved a complete response after primary chemoablation with JELMYTO (n=41), the median duration of response was 47.8 months, irrespective o

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

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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

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