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. |
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