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 |
|---|---|---|---|
| 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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Fireside Chat on November 12, 2024 at 3:00 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 that management will participate in a fireside chat at the Guggenheim Securities Healthcare Innovation Conference to take place November 11-13, 2024. Guggenheim Securities Healthcare Innovation Conference Date / Time: November 12, 2024 at 3:00 PM ET Format: Fireside Chat and 1x1 investor meetings Location: Boston, MA Webcast Link: here A live public webcast from the conference will also be available on UroGen's Investor Relations we
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
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 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 long-term durability of response results from the Phase 3 ENVISION study of investigational drug UGN-102 in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC) were published online
PDUFA goal date set for June 13, 2025 UGN-102 would be the first FDA-approved medicine for LG-IR-NMIBC, if approved 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) for investigational drug UGN-102 (mitomycin) for intravesical solution. UGN-102 could become the first FDA-approved medicine for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 13, 2025.
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
Anticipated advantages of UGN-103 include a shorter manufacturing process and a simpler reconstitution procedure 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 UGN-103 (mitomycin) for intravesical solution in development for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). UGN-103 is a next-generation novel mitomycin-based formulation. "Reaching this Phase 3 trial milestone for UGN-103 highlights our drive to innovate and bring
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 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 received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 18/535,108 entitled "Material and Method for Treating Cancer." The allowed claims relate to the combination of UroGen's RTGel® technology with medac's licensed proprietary
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 Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen's first approved product, and the continued development of the Company's pipeline. Up to 71,800 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 ves
- H.C. Wainwright 26th Annual Global Investment Conference - - 2024 Cantor Global Healthcare Conference - 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. Wainwright 26th Annual Global Investment Conference – September 9-11th, 2024 Fireside Chat: September 9th, 2024 at 9:00am ET Location: New York, NY Webcast Registration Link: Here 2024 Cantor Global Healthcare Conference – September 17-19th, 2024 Fireside Chat: September 18, 2024 at 3:40pm ET Location: New
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 treatments for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). UroGen anticipates potential FDA approval in early 2025, if the NDA is accepted for filing by the FDA and priority review is granted. "The completion of the NDA submission for UGN-102 marks a crucial milestone for UroGen and under
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
HC Wainwright & Co. analyst Raghuram Selvaraju reiterates UroGen Pharma (NASDAQ:URGN) with a Buy and maintains $60 price target.
U.S. stock futures were mixed this morning, with the Nasdaq futures gaining around 0.2% on Tuesday. Shares of NextEra Energy, Inc. (NYSE:NEE) fell sharply in today's pre-market trading after the company announced plans to sell equity units. After the market close on Monday, NextEra Energy announced that it intends to sell $2 billion of equity units consisting of a contract to purchase NextEra Energy common stock and a 5% undivided beneficial ownership interest in a NextEra Energy Capital Holdings debenture due June 1, 2029. Each unit will be issued for $50. AMC Networks shares dipped 7.6% to $66.81 in pre-market trading. Here are some big stocks recording losses in today's pre-ma
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 offering, UroGen also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the total number of ordinary shares (including those underlying pre-funded warrants) offered in the public offering. There can be no assurance as to whether or when the proposed offering may be completed, or as to the act
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 offering, UroGen also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the total number of ordinary shares (including those underlying pre-funded warrants) offered in the public offering. There can be no assurance as to whether or when the proposed offering may be completed, or as to the act
Ladenburg Thalmann analyst Matthew Kaplan maintains UroGen Pharma (NASDAQ:URGN) with a Buy and raises the price target from $48 to $53.5.
U.S. stocks were mostly lower, with the Dow Jones index falling around 300 points on Friday. Shares of Hasbro, Inc. (NASDAQ:HAS) rose sharply during Friday's session after B of A Securities upgraded the stock from Neutral to Buy and raised its price target from $70 to $80. Hasbro shares gained 5.5% to $61.22 on Friday. Here are some other big stocks recording gains in today’s session. Disc Medicine, Inc. (NASDAQ:IRON) shares gained 15.6% to $45.29. Disc Medicine announced a $178 million underwritten offering of 4.944 million shares at $36 per share. UroGen Pharma Ltd. (NASDAQ:URGN) rose 15.4% to $20.19. UroGen Pharma recently announced an 82.3% 12-month duration of response i
Oppenheimer analyst Leland Gershell maintains UroGen Pharma (NASDAQ:URGN) with a Outperform and raises the price target from $32 to $40.
Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades and downgrades, please see our analyst ratings page. HC Wainwright & Co. raised the price target for UroGen Pharma Ltd. (NASDAQ:URGN) from $54 to $60. HC Wainwright & Co. analyst Raghuram Selvaraju maintained a Buy rating. UroGen Pharma shares jumped 37.6% to close at $17.50 on Thursday. See how other analysts view this stock. Keybanc raised the price target for Adobe Inc. (NASDAQ:ADBE) from $445 to $450. Keybanc analyst Jackson Ader maintained an Underweight rating. Adobe shares fell 0.3% to close at $458.74 on Thursday. See how other analysts view
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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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.
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 million in Q1 2023 representing ~10% YoY growth IND accepted for UGN-103, next-generation novel mitomycin-based formulation of UGN-102 to treat LG-IR-NMIBC Conference call and webcast to be held today at 10:00 AM ET UroGen Pharma Ltd. (NASDAQ:URGN), a biote
Conference Call and Webcast Scheduled for Monday, May 13, 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 first quarter financial results on Monday, May 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. About Ur
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 of ~28% compared with 2022 Announced signing of a restructured agreement with Pharmakon Advisors that provides more favorable terms and provides UroGen up to an additional $100 million credit facility Conference call and webcast to be held today at 10:00 AM ET
Conference Call and Webcast Scheduled for Thursday, March 14, 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 fourth quarter and full-year 2023 financial results on Thursday, March 14, 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 approxima
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 UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the third quarter ended September 30, 2023, and provided an overview of recent developments. "During the third quarter, UroGen achieved
Conference Call and Webcast Scheduled for Tuesday, November 14, 2023 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 third quarter 2023 financial results on November 14, 2023, at 8:00 AM EDT, prior to the open of the 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 day
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 UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the second quarter ended June 30, 2023, and provided an overview of recent devel
Conference Call and Webcast Scheduled for Thursday, August 10, 2023 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 2023 financial results on Thursday, August 10, 2023, prior to the open of the 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. Abo