URGN - Earnings announcements

Commercial launch is on-track for ZUSDURI™, the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC); net sales in 2025 were $15.8 million, reflecting the initial launch period ahead of the permanent J CodePermanent J Code for ZUSDURI became effective on January 1, 2026, streamlining reimbursement procedures and supporting broader patient accessJELMYTO® achieved net product sales of $94 million in 2025, representing year-over-year underlying demand sales growth of 7%Announced refinancing of existing term loan with Pharmakon Advisors that provides additional non-dilutive capital at more favorable termsCon

PRINCETON, N.J., Feb. 23, 2026 (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 fourth quarter and full-year 2025 financial results on Monday, March 2nd , 2026, 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 UroGen Pharma

Reported three-month complete response rate of 77.8% from the Phase 3 UTOPIA trial of UGN-103, consistent with ENVISION results; FDA agreed to regulatory plan to submit an NDA based on data from the UTOPIA trial ZUSDURI received unique J-Code (J9282) in October 2025, effective January 1, 2026ZUSDURI achieved net product revenue of $1.8 million in Q3 2025; October 2025 preliminary demand revenue estimate of $4.5 million reflecting accelerating growth entering Q4 2025JELMYTO® achieved net product revenue of $25.7 million in Q3 2025, representing YoY underlying demand revenue growth of 13% $127.4 million in cash, cash equivalents and marketable securities as of September 30, 2025 Conference cal

PRINCETON, N.J., Oct. 30, 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 third quarter 2025 financial results on Thursday, November 6th, 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 UroGen Pharma Ltd. UroG

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.

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

Reported JELMYTO® Q1 2023 net product revenues of $17.2 million, an increase of ~27% from Q1 2022 Complete Response data from ENVISION pivotal trial and topline data readout from ATLAS trial on track for summer 2023 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 first quarter ended March 31, 2023, and provided an overview of recent developments. "2023 is off to a promising start as we reported double-digit year-over-year growth in worldwide JELMYTO net sales during the first quarter," said Liz Barrett, President, and Chief Exec

Conference Call and Webcast Scheduled for Thursday, May 11, 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 2023 first quarter financial results on Thursday, May 11, 2023, 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. Abo

Reported JELMYTO® full year 2022 net product revenues of $64.4 million, an increase of 34% from full year 2021 Completed enrollment of the ENVISION Phase 3 pivotal clinical trial for UGN-102 for LG-IR-NMIBC Topline data readout from ATLAS clinical study and Complete Response from ENVISION pivotal study expected to be reported mid-year 2023 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 fourth quarter and full year ended December 31, 2022, and overview of recent developments. "I'm proud of our progress in 2022 and encouraged by o

Conference Call and Webcast Scheduled for Thursday, March 16, 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 fourth quarter and full-year 2022 financial results on Thursday, March 16, 2023, 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 approximate

Full enrollment of ENVISION Phase 3 pivotal trial with UGN-102 in low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) expected as soon as the end of November 2022; NDA submission anticipated in first half of 2024 Reported JELMYTO® net product revenue of $16.1 million, an increase of 41% from the same period last year FDA authorized extension of the in-use period for JELMYTO® admixture from 8 to 96 hours following reconstitution further simplifying workflow for urologists UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial res

Conference Call and Webcast Scheduled for Thursday, November 10, 2022 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 2022 financial results on Thursday, November 10, 2022, 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

Reported Jelmyto® net product revenue of $16.6 million, a 22% increase from the first quarter of 2022, and 28% increase YoY; reaffirmed 2022 full-year revenue guidance of $70-$80 million Enrollment of UGN-102 Phase 3 single-arm, ENVISION pivotal trial in subjects with low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NBIMC) is ongoing and on track; enrollment completion anticipated before end of 2022 Progressed first in human multi-arm Phase 1 clinical trial of UGN-301 in high-grade non-muscle invasive bladder cancer (HG-NMIBC) Conference call and webcast to be held today at 10:00 AM ET UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing

Conference Call and Webcast Scheduled for Thursday, August 11, 2022 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 2022 financial results on Thursday, August 11, 2022, 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. About

Jelmyto® net product revenue increased 81% over Q1 2021 to $13.6 million Enrollment of UGN-102 Phase 3 single-arm, ENVISION pivotal trial is ongoing; completion of enrollment expected by end of 2022 Initiated novel, multi-arm Phase 1 clinical trial of UGN-301 in high-grade non-muscle invasive bladder cancer (NMIBC) 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 first quarter ended March 31, 2022, and provided an overview of recent developments. "The first quarter of 2

Conference Call and Webcast Scheduled for Tuesday, May 10, 2022 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 2022 financial results on Tuesday, May 10, 2022, 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. Audio Webcast The webcast will be made available on the Investors section of the Company's website at http://investors.urogen.com. Following the live audio webcast, a replay will be available on the Company's website fo

Jelmyto® net product revenue increased 42% over Q3 2021 with $16.2 million in Q4 2021; full-year net product revenue of $48.0 million in line with guidance Announced up to $100 million senior secured term loan facility with funds managed by Pharmakon Advisors, expected to support operations to reach cash flow breakeven by 2025 First patient dosed in ENVISION, single-arm Phase 3 pivotal study for UGN-102 in bladder cancer 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 f

-- Initial Draw of $75 Million Available within 10 Business Days following Closing;  Second Draw of $25 Million Available through the End of 2022 -- -- Reporting of Fourth Quarter and Full-Year Financial Results Rescheduled to March 21, 2022 -- UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the signing of an up to $100 million term loan financing facility with funds managed by Pharmakon Advisors, L.P. The loan facility will be available to UroGen, subject to the terms and conditions of the loan agreement, as follows: Senior secured term loan of up to $100

Conference Call and Webcast Scheduled for Thursday, March 10, 2022, 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 2021 financial results on Thursday, March 10, 2022, 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. Audio Webcast The webcast will be made available on the Investors section of the Company's website at http://investors.urogen.com. Following the live audio webcast, a replay will be available

Shift to single-arm Phase 3 study for UGN-102 in bladder cancer streamlines pivotal study to form basis of FDA submission Jelmyto® net product revenue of $11.4 million for the third quarter of 2021; New patient starts in September and October outpace July and August by nearly 60% Conference call and webcast to be held today at 10:00 AM ET UroGen Pharma Ltd. (NASDAQ:URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, today announced financial results for the third quarter ended September 30, 2021, and provided an overview of the Company's recent developments. "The third quarter of 2021 was one of co

Program to Highlight UGN-102 and Company's Innovative Early-stage Pipeline Programs Company to Report Third Quarter 2021 Financial Results on November 15, 2021 UroGen Pharma Ltd. (NASDAQ:URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that it will host a virtual "Spotlight Event" on Wednesday, November 10, 2021 at 11:00 a.m. Eastern Time. The event will focus on UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC), and the Company's earlier-stage clinical programs including UGN-301 and UGN-302. In addition to p

Strong Jelmyto® net product revenue of $13.0 million for the second quarter of 2021, representing more than 70% growth over the first quarter of 2021 Nearly 100 global centers activated for Phase 3 landmark ATLAS trial with lead pipeline candidate, UGN-102 Commenced Jelmyto geographic expansion efforts with Neopharm license in Israel Conference call and webcast to be held today at 8:30 AM ET UroGen Pharma Ltd. (NASDAQ:URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced financial results for the second quarter ended June 30, 2021, and provided an overview of the Company's re

Conference Call and Webcast Scheduled for Wednesday, August 4, 2021 at 8:30 AM ET UroGen Pharma Ltd. (NASDAQ:URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that it will report second quarter 2021 financial results on Wednesday, August 4, 2021, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 8:30 AM Eastern Time. Audio Webcast The webcast will be made available on the Investors section of the Company's website at http://investors.urogen.com. Following the live audio webcast, a replay will be available on the Com