Earnings summaries and quarterly performance for UroGen Pharma.
Executive leadership at UroGen Pharma.
Board of directors at UroGen Pharma.
Research analysts who have asked questions during UroGen Pharma earnings calls.
LG
Leland Gershell
Oppenheimer & Co. Inc.
4 questions for URGN
Also covers: ARGX, ASND, CAPR +13 more
RS
Raghuram Selvaraju
H.C. Wainwright & Co.
4 questions for URGN
Also covers: ABEO, ACOG, AQST +20 more
Aydin Huseynov
Ladenburg Thalmann
3 questions for URGN
Also covers: ARDX, CAPR, CLRB +3 more
PC
Paul Choi
Goldman Sachs
3 questions for URGN
Also covers: AMRN, ARVN, ASND +12 more
TB
Tara Bancroft
TD Cowen
3 questions for URGN
Also covers: ADVM, CELC, DAWN +10 more
KG
Kelsey Goodwin
Guggenheim Securities
2 questions for URGN
Also covers: MGNX, TSVT
Michael Schmidt
Guggenheim Securities
2 questions for URGN
Also covers: ADAP, ADCT, ARVN +19 more
GF
George Farmer
Scotiabank
1 question for URGN
Also covers: ABSI, ADAP, INMB +7 more
KC
Kyuwon Choi
Goldman Sachs
1 question for URGN
Also covers: AMRN, ASND, BHVN +9 more
MK
Matthew Kaplan
Ladenburg Thalmann
1 question for URGN
Also covers: ARDX, AXSM, CORT +8 more
Recent press releases and 8-K filings for URGN.
UroGen Pharma's ZUSDURI Receives Permanent J Code Effective January 1, 2026
URGN
Product Launch
Revenue Acceleration/Inflection
- UroGen Pharma announced that the permanent Healthcare Common Procedure Coding System Level II J Code, J9282, for its bladder cancer therapy ZUSDURI™ (mitomycin) became effective on January 1, 2026.
- This new code is expected to streamline billing and reimbursement processes across hospital outpatient and physician office settings, reducing administrative delays and improving patient access to ZUSDURI.
- ZUSDURI is the first and only FDA-approved nonsurgical chemoablative therapy for adults with recurrent low-grade intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC).
Jan 5, 2026, 1:00 PM
UroGen Pharma Discusses ZUSDURI Launch Dynamics and Future Outlook
URGN
Product Launch
Guidance Update
Legal Proceedings
- UroGen Pharma's recently approved ZUSDURI (UGN-102) is the first FDA-approved non-surgical option for low-grade, intermediate-risk non-muscle-invasive bladder cancer.
- The commercial launch of ZUSDURI has faced logistical and reimbursement challenges, with patient dosing currently taking up to 60 days. However, the implementation of a permanent J-code on January 1st is anticipated to significantly boost reimbursement confidence and accelerate uptake, with a 220% increase in revenue expected over six months post-J-code, based on an analog.
- The company expects Q4 2025 sales for ZUSDURI to be relatively similar month-over-month to October sales, with substantial growth projected from February/March 2026 onwards. UroGen is also developing UGN-103/UGN-104, a next-generation formulation with patent protection until 2041, intended to replace UGN-102.
Dec 2, 2025, 6:00 PM
UroGen Pharma Discusses ZUSDURI Commercialization and 2026 Outlook
URGN
Product Launch
Revenue Acceleration/Inflection
Legal Proceedings
- UroGen Pharma's recently approved drug, UGN-102 (ZUSDURI), for low-grade, intermediate-risk non-muscle-invasive bladder cancer, is experiencing initial commercialization hurdles, primarily a 60-day cycle from patient identification to dosing due to its procedural nature and current reimbursement complexities.
- The company anticipates a significant boost in adoption and sales for UGN-102 with the permanent J-code becoming effective on January 1, 2026, as 70% of physicians are awaiting its implementation.
- While Q4 2025 sales are expected to be relatively similar to October's due to holidays and physicians waiting for the J-code, UroGen projects a substantial revenue acceleration in the first six months of 2026 following the J-code, citing a 220% increase from an analog.
- UroGen plans to launch UGN-103/104, a next-generation formulation, to replace UGN-102, which will extend patent protection until 2041.
Dec 2, 2025, 6:00 PM
UroGen Pharma CEO Discusses ZUSDURI Launch and 2026 Outlook
URGN
Product Launch
Guidance Update
New Projects/Investments
- UroGen Pharma's CEO discussed the recent launch of ZUSDURI (UGN-102), the first FDA-approved non-surgical option for low-grade, intermediate-risk non-muscle-invasive bladder cancer.
- Commercialization of ZUSDURI faces logistical hurdles, with the time from patient enrollment to dosing currently up to 60 days. Many physicians are waiting for the permanent J-code, effective January 1, 2026, before widely adopting the drug.
- The company anticipates Q4 2025 sales for ZUSDURI to be relatively similar to October sales, with a more significant revenue increase expected in February and March 2026, and into Q2 2026, following the J-code implementation. They project a 220% increase in revenue in the six months post-J-code, based on an analog.
- UroGen plans to replace UGN-102 with next-generation formulations, UGN-103 and UGN-104, which will extend patent protection until 2041.
Dec 2, 2025, 6:00 PM
UroGen Pharma Discusses UGN-102 Launch and Pipeline Development
URGN
Product Launch
Revenue Acceleration/Inflection
New Projects/Investments
- UroGen Pharma's UGN-102 (Zesturi), approved in June 2025, generated $1.8 million in Q3 revenue and $4.5 million in October alone, with patient enrollment forms for UGN-102 currently matching the pace of Jelmyto after five years on the market.
- The company anticipates a significant acceleration in UGN-102 revenue post-January 2026 with the implementation of the permanent J-code, citing a comparable product's 220% revenue increase in the six months following its J-code implementation.
- UroGen Pharma projects UGN-102 to achieve over $1 billion in peak sales, representing approximately 20% market penetration of the 60,000-patient opportunity for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
- Pipeline updates include UGN-103, a new formulation of Zesturi with an NDA filing planned for H2 2026 and approval in 2027, and UGN-501, an oncolytic virus entering Phase 1 in 2026.
Nov 11, 2025, 3:30 PM
UroGen Pharma Reports Q3 2025 Financial Results and Zesturi Launch Progress
URGN
Earnings
Product Launch
Guidance Update
- Total revenues for URGN in Q3 2025 were $27.5 million, with Gemyto sales at $25.7 million and Zesturi sales at $1.8 million.
- The company maintains its full-year 2025 Gemyto net product revenue guidance of $94-$98 million, implying 8%-12% year-over-year growth.
- Zesturi, launched on July 1, 2025, generated $1.8 million in sales for Q3 2025 and has a preliminary demand revenue estimate of $4.5 million for October.
- A permanent J code for Zesturi, effective January 1, 2026, is expected to accelerate adoption by simplifying reimbursement and reducing administrative barriers, particularly in community settings.
- URGN reported a net loss of $33.3 million, or $0.69 per basic and diluted share, for Q3 2025, and held $127.4 million in cash, cash equivalents, and marketable securities as of September 30, 2025.
Nov 6, 2025, 3:00 PM
UroGen Pharma Reports Q3 2025 Financial Results and ZUSDURI Launch Momentum
URGN
Earnings
Product Launch
Guidance Update
- UroGen Pharma Ltd. reported total revenues of $27.5 million and a net loss of $33.3 million, or ($0.69) per basic and diluted share, for the third quarter ended September 30, 2025.
- The newly launched ZUSDURI achieved net product revenue of $1.8 million in Q3 2025, with a preliminary demand revenue estimate of $4.5 million for October 2025, reflecting accelerating commercial uptake. A unique J-Code (J9282) for ZUSDURI will be effective January 1, 2026.
- JELMYTO generated $25.7 million in net product revenue for Q3 2025, showing 13% year-over-year underlying demand revenue growth. The company reiterated its full-year 2025 JELMYTO net product revenue guidance of $94 million to $98 million.
- As of September 30, 2025, UroGen held $127.4 million in cash, cash equivalents, and marketable securities.
- The Phase 3 UTOPIA trial for UGN-103 reported a 77.8% complete response rate, with an NDA submission anticipated in H2 2026. The company also decided to discontinue development of UGN-301.
Nov 6, 2025, 1:00 PM
UroGen Pharma Reports Q3 2025 Financial Results and ZUSDURI Launch Momentum
URGN
Earnings
Product Launch
Revenue Acceleration/Inflection
- UroGen Pharma reported total revenue of $27.5 million for the third quarter ended September 30, 2025, with a net loss of $33.3 million, or ($0.69) per basic and diluted share.
- The company's new product, ZUSDURI, launched after FDA approval on June 12, 2025, generated $1.8 million in net product revenue in Q3 2025, with an October 2025 preliminary demand revenue estimate of $4.5 million. ZUSDURI also received a unique J-Code (J9282) effective January 1, 2026.
- JELMYTO achieved net product revenue of $25.7 million in Q3 2025, representing 13% year-over-year underlying demand revenue growth.
- As of September 30, 2025, UroGen Pharma held $127.4 million in cash, cash equivalents, and marketable securities.
- In pipeline developments, the Phase 3 UTOPIA trial for UGN-103 reported a three-month complete response rate of 77.8%, and the FDA agreed to a regulatory plan for an NDA submission in the second half of 2026. The development of UGN-301 was discontinued.
Nov 6, 2025, 1:00 PM
UroGen Pharma Announces Positive Phase 3 UTOPIA Trial Results for UGN-103 and FDA Agreement for NDA Submission
URGN
New Projects/Investments
- UroGen Pharma reported robust preliminary results from its Phase 3 UTOPIA trial for UGN-103, demonstrating a 77.8% three-month complete response (CR) rate in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
- The U.S. Food and Drug Administration (FDA) agreed that the UTOPIA trial results can support the submission of a New Drug Application (NDA) for UGN-103, with UroGen planning the submission in 2026.
- UGN-103 is designed to offer improvements over the existing FDA-approved treatment, ZUSDURI, and is protected by patents until December 2041.
Nov 6, 2025, 12:58 PM
UroGen Pharma Secures Permanent J Code for ZUSDURI
URGN
Product Launch
New Projects/Investments
- UroGen Pharma announced that the Centers for Medicare and Medicaid Services (CMS) has assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II J Code, J9282, for ZUSDURI (mitomycin) for intravesical solution.
- Effective January 1, 2026, this J Code is expected to facilitate standardized billing and claims submission for ZUSDURI, which is the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
- The company views this as an important operational milestone for the ZUSDURI launch, aiming to simplify reimbursement processes for providers and ensure streamlined patient access to the treatment.
Oct 27, 2025, 12:00 PM
Quarterly earnings call transcripts for UroGen Pharma.
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