Track market-moving stories before they get noisy

PRINCETON, N.J., Aug. 17, 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 the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug UGN-103 (mitomycin) for intravesical solution. UGN-103 is a next-generation mitomycin formulation being developed for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). It is built on the clinical and commercial foundation of ZUSDURI (mitomycin) for intravesical solution.

"The NDA submission for UGN-103 marks another important milestone in advancing our vision to redefine the treatment of urothelial cancers," said Liz Barrett, President and CEO of UroGen. "UGN-103 represents the next evolution in our portfolio and is designed to provide a more streamlined manufacturing process, simplified reconstitution and extended shelf-life of the reconstituted product while leveraging our RTGel® technology."

The NDA for UGN-103 is supported by the clinical data from the ongoing Phase 3 UTOPIA trial, a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 in adult patients with recurrent LG-IR-NMIBC. UGN-103 demonstrated a 77.8% three-month complete response (CR) rate (95% CI: 68.3%, 85.5%) and a 94.5% six-month duration of response (DOR) by Kaplan-Meier estimate (95% CI: 86.1%, 97.9%). Both the three-month CR rate and the DOR observed at six months with UGN-103 in the UTOPIA trial are consistent with those observed in the pivotal ENVISION trial of ZUSDURI. Because these findings are derived from separate clinical studies, no formal cross-trial comparison was performed.

About UGN-103
In January 2024, UroGen entered into a licensing and supply agreement with medac to develop UGN-103 for recurrent LG-IR-NMIBC. UGN-103 is designed to reinforce and build on the clinical and commercial foundation of ZUSDURI, the first and only FDA-approved treatment for adults with recurrent LG-IR-NMIBC. The program maintains UroGen’s innovative and proven RTGel technology, enabling sustained mitomycin exposure in the bladder, while incorporating next-generation enhancements, including a more streamlined manufacturing process and simplified reconstitution to support improved ease of use in clinical practice. UroGen holds U.S. patents covering the combination of its proprietary RTGel technology with medac’s licensed lyophilized mitomycin formulation, as well as the use of UGN-103 in LG-IR-NMIBC, with intellectual property coverage expected to extend into July 2044.

About ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means. 

About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the United States every year and of those, an estimated 59,000 are people experiencing recurrence. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about NMIBC at www.BladderCancerAnswers.com.

About UTOPIA
The UTOPIA trial is a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 in 99 patients across global sites. Enrolled patients received 75 mg of UGN-103 via intravesical instillation in an outpatient setting once weekly for six weeks. The primary endpoint is CR rate at three months, with responders entering a follow-up phase of up to 12 months to assess DOR. For more information on the UTOPIA study, please visit https://clinicaltrials.gov/study/NCT06331299.

About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen’s first product treats low-grade upper tract urothelial cancer and UroGen’s second product, ZUSDURI (mitomycin) for intravesical solution, treats adult patients with recurrent LG-IR-NMIBC; both are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel.

Visit www.UroGen.com to learn more or follow us on X (formerly Twitter), @UroGenPharma.

About medac
At medac group, we believe that health is humanity’s most valuable resource. Since 1970, our mission has been to improve patients’ quality of life worldwide by making the best medical treatments available. As a globally operating pharmaceutical company headquartered in Germany, we provide high-quality medical treatments for patients worldwide in over 90 countries. With more than 2,000 employees, we are committed to improving human health.

Our products are manufactured in Germany and other European countries to the highest standards, utilizing our own logistics center and production sites, and subsequently distributed worldwide.

 We are constantly working to improve authorized medicines and to develop innovative therapies in the fields of rheumatology, urology, hematology, and oncology. Part of our mission is to provide safe, high-quality and innovative original products, as well as generics and biosimilars. In this way, we make vital treatments accessible to those affected.

For more information, please visit www.medac-group.com.

APPROVED USE FOR ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after you have previously received bladder surgery to remove tumor and it did not work or is no longer working.

IMPORTANT SAFETY INFORMATION

You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI.

Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you:

have kidney problemsare pregnant or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose.

Males being treated with ZUSDURI: You should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose.

are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose.
How will I receive ZUSDURI?

You will receive your ZUSDURI dose from your healthcare provider 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter. It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider’s instructions.If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving ZUSDURI:

ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 hours.To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
The most common side effects of ZUSDURI include: increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increased or decreased white blood cell counts, urinary tract infection, blood in your urine.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Please see ZUSDURI Full Prescribing Information, including the Patient Information, for additional information.

ZUSDURI® and UroGen® are registered trademarks of UroGen Pharma, Ltd.

Copyright©2026 UroGen Pharma, Inc. All rights reserved.

Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: UGN-103 representing the next evolution in UroGen’s portfolio and the potential benefits of UGN-103 as compared to ZUSDURI, including its streamlined manufacturing, reconstitution processes, and extended shelf-life; the expected duration of intellectual property protection for UGN-103; the estimated annual U.S. patient population and demographics for LG-IR-NMIBC; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs other than mitomycin; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. Words such as “can,” “estimated,” “expect,” “may,” “potential,” or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: preliminary clinical results may not be indicative of results that may be observed in the future; potential safety and other complications related to UroGen’s products and product candidates; risks related to our and our licensors’ ability to protect our respective patents and other intellectual property, including the fact that UroGen’s or its licensors’ pending patent applications may not be successful, and in such event, the duration of intellectual property protection would be more limited; the ability to maintain regulatory approval; complications associated with commercialization activities; labeling limitations; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s products and product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies or procedures, such as surgery; UroGen’s ability to attract or retain key management, members of the board of directors and other personnel; UroGen’s RTGel technology and UroGen’s products and product candidates may not perform as expected; the data from the UTOPIA trial may not be sufficient to support approval of UGN-103; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; and the impacts of general macroeconomic and geopolitical conditions on UroGen’s business and financial position. These and other risks and uncertainties are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the U.S. Securities and Exchange Commission on August 5, 2026. In light of these risks and uncertainties, the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.

INVESTOR:
Vincent Perrone
Senior Director, Investor Relations
[email protected]
609-460-3588 ext. 1093

MEDIA:
Cindy Romano
Director, Corporate Communications
[email protected]
609-460-3566 ext. 1083

ZUSDURI® generated $50.4 million in revenue in the second quarter of 2026, representing 73% quarter-over-quarter growthOnce issued, new U.S. patent is expected to provide protection into July 2044 for ZUSDURI and UGN-103Continued advancement of pipeline, with UGN-103 on track for NDA submission in the third quarter of 2026 and UGN-501 expected to begin a Phase 1 trial in the fourth quarter of 2026Conference call and webcast held today at 10:00 AM ET PRINCETON, N.J., Aug. 05, 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 financial results for the second quarter ended June 30, 2026, and provided an overview of recent developments.

“The second quarter marked another important step in establishing ZUSDURI as a foundational therapy for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer,” said Liz Barrett, President and Chief Executive Officer of UroGen. “The continued increase in utilization, expanding adoption across community practices, and growing repeat use reinforce our confidence we are building a durable commercial franchise with blockbuster potential. During the quarter, we strengthened the long-term sustainability of the franchise through a new U.S. patent allowance that, once the patent is issued, is expected to provide intellectual property coverage for both ZUSDURI and UGN-103 into July 2044. We believe this meaningfully enhances the long-term commercial opportunity for both products and further reinforces the sustainability of the franchise. Combined with the life-cycle expansion of UGN-103 and initiation of clinical development for UGN-501, we believe we are exceptionally well positioned to build a durable growth company and create long-term shareholder value.”

Q2 2026 and Recent Business Highlights:

ZUSDURI (mitomycin) for intravesical solution:

ZUSDURI achieved net product revenue of $50.4 million in the second quarter of 2026, representing 73% growth over the first quarter of 2026. As of June 30, 2026, UroGen reported: 1,444 activated sites of care452 unique ZUSDURI prescribers204 repeat ZUSDURI prescribers, representing approximately 45% of total prescribers, up from 40% in the first quarter of 2026 Updated results from the Phase 3 ENVISION trial of ZUSDURI showed a 36-month duration of response (DOR) of 64.5% (95% CI: 54.6, 72.8) by Kaplan-Meier estimate among patients who achieved a complete response (CR) at three months (79.6%). At a median follow-up of 35.5 months, the median DOR had not been reached. ZUSDURI’s durability was achieved without maintenance therapy, supporting a treatment approach that can provide lasting disease control while reducing treatment burden for patients.UroGen received a Notice of Allowance from the U.S. Patent and Trademark Office for a new U.S. patent covering methods of treating patients with recurrent, low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) without transurethral resection of bladder tumor (TURBT). Once issued, the patent is expected to provide protection into July 2044, further strengthening the intellectual property supporting ZUSDURI and UGN-103 and reinforcing the long-term commercial opportunity for both products. American Urological Association (AUA) Key Opinion Leader Webinar:

On May 17, 2026, UroGen hosted a Key Opinion Leader webinar at the AUA Annual Meeting in Washington, D.C., focused on real-world experience with ZUSDURI. The discussion highlighted patient selection, workflow integration, treatment patterns, and physician experience across both hospital and community practices, reinforcing growing confidence in the use of ZUSDURI in routine clinical practice. A replay of the event is accessible through the Investors section of the Company’s website. JELMYTO (mitomycin) for pyelocalyceal solution in LG-UTUC:

Generated net product revenue of $22.0 million in the quarter ended June 30, 2026, compared with $24.2 million reported for the second quarter of 2025. The Company continues to add new users and remains on track to deliver within its JELMYTO full-year 2026 guidance range of $97 million to $101 million.UroGen entered into a settlement and license agreement with Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals, USA, Inc. (collectively, “Teva”) that resolves the patent litigation UroGen initiated in response to Teva’s submission of an Abbreviated New Drug Application to the U.S. FDA for a generic version of JELMYTO prior to the expiration of the relevant UroGen patents. Under the terms of the agreement, UroGen granted Teva a non-exclusive license to sell its generic version of JELMYTO beginning on September 15, 2030, if approved by the FDA, unless certain limited circumstances customarily included in these types of agreements occur. Next-generation novel mitomycin-based formulations for urothelial cancer:

UGN-103 achieved a 94.5% (95% CI: 86.1, 97.9) DOR at six months by Kaplan-Meier estimate, in the ongoing Phase 3 UTOPIA trial in patients with LG-IR-NMIBC. The six-month results from UTOPIA are generally consistent with the 91.9% (95% CI: 86.9, 95.0) six-month DOR by Kaplan-Meier estimate observed with ZUSDURI in the pivotal ENVISION trial.UroGen remains on track to submit a New Drug Application (NDA) for UGN-103 in the third quarter of 2026, with potential FDA approval in 2027 and full launch anticipated following receipt of a unique J-Code. UGN-103 is designed to build on the clinical and commercial foundation of ZUSDURI. The benefits of UGN-103 include a more streamlined manufacturing process and simplified reconstitution, while preserving the innovative and proven RTGel® technology that enables sustained drug exposure at tumor sites in the bladder.The Company expects to initiate a randomized controlled Phase 3 trial evaluating UGN-103 in high-risk NMIBC in the second half of 2026, and a trial evaluating UGN-103 as adjuvant therapy in newly diagnosed intermediate-risk NMIBC patients in 2027.The Phase 3 clinical trial evaluating UGN-104 in low-grade upper tract urothelial cancer (LG-UTUC) remains on track to complete enrollment by the end of 2026. UGN-501 (investigational next-generation oncolytic virus) for use in high-grade non-muscle invasive bladder cancer:

UroGen’s Investigational New Drug application for UGN-501 has been accepted by the FDA, and the Company plans to initiate its Phase 1 clinical trial in NMIBC in the fourth quarter of 2026. Second Quarter 2026 Financial Results

Revenue: Total revenue was $72.5 million in the second quarter of 2026, compared with $24.2 million in the second quarter of 2025. The increase was driven by the continued commercial launch of ZUSDURI.

Research and Development (R&D) Expenses: R&D expenses were $17.3 million in the second quarter of 2026, including non-cash share-based compensation expense of $0.9 million. This compares to $18.9 million, including non-cash share-based compensation expense of $0.4 million, in the same period in 2025. The decrease in R&D expenses was primarily attributable to ZUSDURI manufacturing costs, which were recognized as an R&D expense in the second quarter of 2025 prior to receiving FDA approval.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $48.4 million in the second quarter of 2026, including non-cash share-based compensation expense of $4.4 million. This compares to $43.2 million, including non-cash share-based compensation expense of $2.3 million, in the same period in 2025. The increase in SG&A expenses was primarily attributable to ZUSDURI commercial activities, including the sales force expansion following ZUSDURI approval and higher brand marketing expenses, and an increase in overall commercial operation costs.

Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $4.5 million in the second quarter of 2026, compared with $4.6 million in the same period in 2025.

Interest Expense on Long-term Debt: Interest expense related to long-term debt was $4.9 million in the second quarter of 2026, compared with $4.1 million in the same period in 2025. The increase in interest expense was primarily attributable to the additional borrowings of $75.0 million in the first quarter of 2026 in connection with the Pharmakon refinancing of long-term debt, offset by the lower interest rate.

Net Loss: UroGen reported a net loss of $14.4 million, or $0.28 per basic and diluted share, in the quarter ended June 30, 2026, compared with a net loss of $49.9 million, or ($1.05) per basic and diluted share, in the second quarter of 2025.

Cash, Cash Equivalents and Marketable Securities: As of June 30, 2026, cash, cash equivalents and marketable securities totaled $108.0 million.

2026 JELMYTO Revenue and Updated Company Operating Expense Guidance: The Company continues to expect 2026 net product revenue for JELMYTO to be in the range of $97 million to $101 million. This implies a year-over-year growth rate of approximately 3% to 7% over the $94 million of JELMYTO revenue reported in 2025. The Company is not providing full-year 2026 revenue guidance for ZUSDURI at this time, as the product remains in the early stages of its commercial launch. The Company is increasing its full-year 2026 operating expenses guidance to be in the range of $260 million to $270 million, including non-cash share-based compensation expense of $20 million to $24 million. The increase reflects the decision to accelerate investment behind the business in response to the continued strength of the ZUSDURI launch. Specifically, the Company plans to increase investment in ZUSDURI peer-to-peer promotional education and patient awareness initiatives to support long-term commercial adoption, and also accelerate start-up activities for the UGN-103 high-grade NMIBC trial and development activities of UGN-501 with RTGel®.

Conference Call & Webcast Information: Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review UroGen’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at investors.UroGen.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

UROGEN PHARMA LTD.SELECTED CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands)(Unaudited)            June 30, 2026 December 31, 2025Cash and cash equivalents and marketable securities $107,976  $120,456 Total assets $252,590  $200,455 Total liabilities $384,986  $305,929 Total shareholders' deficit $(132,396) $    (105,474)          UROGEN PHARMA LTD.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(U.S. dollars in thousands, except share and per share data)(Unaudited)          Three months ended June 30, Six months ended June 30,   2026   2025   2026   2025           Revenue$72,456  $24,215  $123,415  $44,469  Cost of revenue                        6,572                          3,550                          10,711                          5,880  Gross profit                      65,884                        20,665                        112,704                        38,589  Operating expenses:        Research and development expenses                      17,336                        18,914   32,933   38,785  Selling, general and administrative expenses 48,437   43,199   99,923   78,166  Total operating expenses                      65,773                        62,113                        132,856                        116,951  Operating income (loss)                   111   (41,448)  (20,152)  (78,362) Financing on prepaid forward obligation (4,545)  (4,644)  (9,051)  (9,227) Interest expense on long-term debt (4,887)  (4,132)  (9,072)  (8,200) Interest and other income, net                            599                              1,299                          1,207   3,413  Loss before income taxes$(8,722) $(48,925) $(37,068) $(92,376) Income tax expense (5,629)                                (1,015)                             (857)  (1,407) Net loss$(14,351) $(49,940) $(37,925) $(93,783) Net loss per ordinary share basic and diluted$(0.28) $(1.05) $(0.75) $(1.97) Weighted average shares outstanding, basic and diluted 50,380,112               47,739,816               50,282,221               47,582,610                    About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technology, a sustained release, hydrogel-based formulation, ZUSDURI is delivered directly into the bladder in an out-patient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means.

APPROVED USE FOR ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after previously receiving bladder surgery to remove a tumor that did not work or is no longer working.

IMPORTANT SAFETY INFORMATION

You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI.

Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you:

have kidney problems.are pregnant or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI.Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose.

Males being treated with ZUSDURI: You should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose.

are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose. How will I receive ZUSDURI?

You will receive your ZUSDURI dose from your healthcare provider 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter. It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider’s instructions.If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines. After receiving ZUSDURI:

ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 hours.To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.Clothing that comes in contact with urine should be washed right away and washed separately from other clothing. The most common side effects of ZUSDURI include: increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increased or decreased white blood cell counts, urinary tract infection, and blood in your urine.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Please see ZUSDURI Full Prescribing Information, including the Patient Information, for additional information.

About JELMYTO

JELMYTO® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel approved for the treatment of adult patients with LG-UTUC. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through a nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemo-ablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.

APPROVED USE FOR JELMYTO

JELMYTO® is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose. Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.JELMYTO is given to your kidney through a tube called a catheter.During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.JELMYTO may cause serious side effects, including:Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.

About UroGen Pharma Ltd.

UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen’s first product to treat LG-UTUC and second product (mitomycin) for intravesical solution for patients with recurrent LG-IR-NMIBC are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.urogen.com to learn more or follow us on X, @UroGenPharma.

Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the potential benefits and expected length of patent protection for ZUSDURI and UGN-103; UroGen’s planned and ongoing clinical trials and non-clinical studies and the timing for regulatory submissions and potential regulatory approvals for its product candidates, including UGN-103, UGN-104, and UGN-501; the belief in the significant commercial opportunity ahead and UroGen’s ability to fully capitalize on it; 2026 JELMYTO revenue and company operating expense guidance; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs other than mitomycin; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. Words such as “anticipate,” “believe,” “can,” “continue,” “estimate,” “expect,” “may,” “on track,” “plan,” “potential,” “will,” or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: clinical results may not be indicative of results that may be observed in the future, including in larger populations; potential safety and other complications related to UroGen’s products; risks related to UroGen’s and its licensors’ ability to protect their respective patents and other intellectual property, including that UroGen’s or its licensors’ pending patent applications may not be successful, and in such event, the duration of intellectual property protection would be more limited; the ability to maintain regulatory approval; complications associated with commercialization activities; labeling limitations; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s products and product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies or procedures, such as surgery; UroGen’s ability to attract or retain key management, members of the board of directors and other personnel; UroGen’s RTGel technology and ZUSDURI may not perform as expected; new data relating to ZUSDURI, including from spontaneous adverse event reports and from the ongoing ENVISION trial, may result in changes to the product label and may adversely affect sales, or result in withdrawal of ZUSDURI from the market; the potential for payors to delay, limit or deny coverage for ZUSDURI; the data from the UTOPIA trial may not be sufficient to support approval of UGN-103; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; and the impacts of general macroeconomic and geopolitical conditions on UroGen’s business and financial position. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 6, 2026, as well as in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q being filed with the SEC later today, the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.

INVESTOR CONTACT:
Vincent Perrone
Senior Director, Investor Relations
[email protected]
609-460-3588 ext. 1093

MEDIA CONTACT:
Cindy Romano
Director, Corporate Communications
[email protected]
609-460-3566 ext. 1083

Source: UroGen Pharma Ltd.

Mark Schoenberg, Chief Medical Officer, sold 10,000 ordinary shares of UroGen Pharma Ltd. (URGN 4.15%) on July 9, 2026, for a total value of $400,000, according to an SEC Form 4 filing.

Transaction summaryMetricValueTransaction value$400,000Shares sold10,000Post-transaction shares (directly held)119,763Post-transaction value$4.82 millionKey questionsWhat was the mechanism for this transaction?
The sale was conducted under a pre-established Rule 10b5-1 trading plan adopted on August 15, 2025, which provides for automated execution and represents the concluding transaction of that plan's schedule.What is the scale of the insider's remaining direct investment?
Mark Schoenberg continues to hold 119,763 ordinary shares directly.What financial context does UroGen Pharma Ltd. present at this valuation?
The biotechnology company, which develops solutions for urothelial and specialty cancers, reported trailing 12-month revenue of $140.5 million and a net loss of $133.2 million.How does the current market capitalization compare to the transaction level?
The disposition occurred with the company's market capitalization at $2.0 billion, following a period of performance where shares were priced at $40.23 as of the July 9, 2026 market close.Company OverviewMetricValueShare Price (as of market close 2026-07-09)$40.23Market Capitalization$2.0 billionRevenue (TTM)$140.5 millionNet Income (TTM)-$133.2 millionCompany SnapshotUroGen Pharma develops and commercializes innovative solutions for urothelial and specialty cancers, with primary revenue sources including Zusduri, a sustained-release mitomycin formulation for non-muscle invasive bladder cancer, and RTGel, a proprietary reverse thermal gelation hydrogel technology platform.The company operates a commercial-stage biotechnology business model focused on bringing novel therapeutic formulations to market, generating revenue through product sales while continuing to invest in research and development for pipeline expansion.UroGen's primary customers are urology and oncology specialists, with target markets encompassing patients with non-muscle invasive bladder cancer and other urothelial malignancies requiring adjuvant chemotherapy and specialized treatment modalities.UroGen Pharma is a commercial-stage biotechnology company with a $2 billion market capitalization, demonstrating significant growth momentum with a one-year stock appreciation of 191.31%. The company has achieved meaningful revenue scale at $140.5 million TTM while maintaining a focused pipeline strategy centered on proprietary drug delivery technologies for underserved oncology indications. UroGen's competitive advantage derives from its proprietary RTGel platform technology and its established commercial infrastructure for specialty cancer therapeutics, positioning the company as a differentiated player in the niche urothelial cancer treatment market.

What this transaction means for investorsFirst, it’s important to note that this was the final trade in a 10b5-1 plan Schoenberg set almost a year ago, so the timing was locked in long before Schoenberg could know how the firm was necessarily going to be performing. He still holds nearly 120,000 shares worth close to $4.8 million, and a chief medical officer keeping a stake that size while the company's newest drug is inflecting isn't sending any signal about the science.

The launch of Zusduri, UroGen’s new bladder cancer therapy, is what matters here, and it's going well. UroGen's first quarter revenue jumped 152% to $51 million, as a result of the launch, which brought in $29.2 million and more than doubled quarter over quarter after a permanent insurance billing code kicked in. CEO Liz Barrett called January's J-code "a major inflection point," and unique prescribers jumped to 256 from 102 in a single quarter. More recently, the firm announced that the FDA cleared its investigational new drug application for UGN-501, enabling a planned Phase 1 study in patients with non-muscle invasive bladder cancer. It’s expected to begin in the fourth quarter.

Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.