SCHEDULE 13G/A - UroGen Pharma Ltd. (0001668243) (Subject)

SCHEDULE 13G/A - UroGen Pharma Ltd. (0001668243) (Subject)

10-Q - UroGen Pharma Ltd. (0001668243) (Filer)

8-K - UroGen Pharma Ltd. (0001668243) (Filer)

10-K/A - UroGen Pharma Ltd. (0001668243) (Filer)

SCHEDULE 13G/A - UroGen Pharma Ltd. (0001668243) (Subject)

10-K - UroGen Pharma Ltd. (0001668243) (Filer)

8-K - UroGen Pharma Ltd. (0001668243) (Filer)

8-K - UroGen Pharma Ltd. (0001668243) (Filer)

SCHEDULE 13G/A - UroGen Pharma Ltd. (0001668243) (Subject)

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

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 UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced patient-reported outcomes following treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) that showed investigational drug UGN-102 (mitomycin) for intravesical solution achieved robust and durable complete response (CR) rates without negatively impacting quality of life.

Data Presented at the American Urological Association 2025 Annual Meeting in Las Vegas, Nevada 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 clinically meaningful two-year duration of response (24.2 months) by Kaplan-Meier analysis. UGN-102 is UroGen's sustained-release formulation of mitomycin being developed for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). "The median duration of response of tw

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 UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced an updated 18-month DOR of 80.6% (95% CI: 74.0, 85.7), by Kaplan-Meier estimate, from the Phase 3 ENVISION trial of UGN-102 (mitomycin) for intravesical solution, an investigational treatment for recurrent LG-IR-NMIBC. These data were featured today in

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 Vegas, Nevada UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced encouraging safety data from the Phase 1 dose-escalation study for UG

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.

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

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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4 - UroGen Pharma Ltd. (0001668243) (Issuer)

4 - UroGen Pharma Ltd. (0001668243) (Issuer)

4 - UroGen Pharma Ltd. (0001668243) (Issuer)

3 - UroGen Pharma Ltd. (0001668243) (Issuer)

4 - UroGen Pharma Ltd. (0001668243) (Issuer)

4 - UroGen Pharma Ltd. (0001668243) (Issuer)

4 - UroGen Pharma Ltd. (0001668243) (Issuer)

4 - UroGen Pharma Ltd. (0001668243) (Issuer)

4 - UroGen Pharma Ltd. (0001668243) (Issuer)