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PRINCETON, N.J., Sept. 04, 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 grants of inducement restricted stock units (“RSUs”) to 19 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of JELMYTO® (mitomycin) for pyelocalyceal solution and ZUSDURI™ (mitomycin) for intravesical solution, UroGen’s only approved products, and the continued development of UroGen’s pipeline.

Up to 117,100 ordinary shares of UroGen are issuable upon the vesting and settlement of the RSUs. The RSUs will vest equally over three years, with one-third of the underlying shares vesting each year on the anniversary of the vesting date, subject in each case to the employee’s continued service relationship with UroGen.

The RSUs are subject to the terms and conditions of UroGen’s 2019 Inducement Plan and RSU grant notice and agreement thereunder. The RSUs were granted as an inducement material to each employee entering into employment with UroGen in accordance with Nasdaq Listing Rule 5635(c)(4).

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 commercial product is approved to treat low-grade upper tract urothelial cancer, and UroGen’s second product is the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Both medicines are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, New Jersey with operations in Israel. To learn more, visit www.urogen.com or follow us on X, @UroGenPharma.

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

INVESTOR CONTACT:
Vincent Perrone
[email protected]
(609) 460-3588 Ext. 1093

MEDIA CONTACT:
Cindy Romano
[email protected]
(609) 460-3566 Ext. 1083

BlackRock Inc. purchased a new position in Urogen Pharma (NASDAQ:URGN – Free Report) in the 2nd quarter, according to its most recent 13F filing with the Securities and Exchange Commission. The institutional investor purchased 3,201,461 shares of the company’s stock, valued at approximately $117,814,000. BlackRock Inc. owned 6.57% of Urogen Pharma at the end of the most recent reporting period.

Other hedge funds and other institutional investors have also made changes to their positions in the company. Osaic Holdings Inc. grew its holdings in Urogen Pharma by 491.2% during the 2nd quarter. Osaic Holdings Inc. now owns 3,695 shares of the company’s stock valued at $50,000 after buying an additional 3,070 shares in the last quarter. Persistent Asset Partners Ltd bought a new position in shares of Urogen Pharma during the 2nd quarter valued at approximately $66,000. Russell Investments Group Ltd. raised its holdings in Urogen Pharma by 1,594.4% during the 3rd quarter. Russell Investments Group Ltd. now owns 3,321 shares of the company’s stock valued at $66,000 after buying an additional 3,125 shares during the period. Tower Research Capital LLC TRC raised its holdings in Urogen Pharma by 422.0% during the 2nd quarter. Tower Research Capital LLC TRC now owns 6,891 shares of the company’s stock valued at $94,000 after buying an additional 5,571 shares during the period. Finally, Nebula Research & Development LLC bought a new stake in Urogen Pharma in the second quarter worth $162,000. Institutional investors own 91.29% of the company’s stock.

Wall Street Analyst Weigh In A number of equities analysts recently commented on URGN shares. Weiss Ratings reaffirmed a “sell (d-)” rating on shares of Urogen Pharma in a research note on Friday, July 17th. The Goldman Sachs Group reissued a “neutral” rating and issued a $44.00 price objective on shares of Urogen Pharma in a research report on Wednesday, July 15th. TD Cowen raised their price objective on shares of Urogen Pharma from $50.00 to $60.00 and gave the stock a “buy” rating in a research note on Wednesday, August 5th. LADENBURG THALM/SH SH initiated coverage on Urogen Pharma in a report on Monday, May 11th. They set a “buy” rating and a $43.00 price objective for the company. Finally, Guggenheim upped their price objective on Urogen Pharma from $42.00 to $58.00 and gave the company a “buy” rating in a research report on Thursday, August 6th. One investment analyst has rated the stock with a Strong Buy rating, seven have assigned a Buy rating, one has assigned a Hold rating and one has issued a Sell rating to the company’s stock. According to data from MarketBeat, the stock has a consensus rating of “Moderate Buy” and a consensus price target of $50.38.

View Our Latest Stock Analysis on URGN Urogen Pharma Price Performance Shares of NASDAQ URGN opened at $43.62 on Friday. The stock has a market capitalization of $2.13 billion, a P/E ratio of -22.03 and a beta of 1.57. Urogen Pharma has a 1-year low of $15.86 and a 1-year high of $50.81. The business has a fifty day moving average price of $41.81 and a 200 day moving average price of $29.95.

Urogen Pharma (NASDAQ:URGN – Get Free Report) last posted its earnings results on Wednesday, August 5th. The company reported ($0.28) EPS for the quarter, missing analysts’ consensus estimates of ($0.26) by ($0.02). The company had revenue of $72.46 million for the quarter, compared to the consensus estimate of $63.55 million. As a group, equities research analysts anticipate that Urogen Pharma will post -0.2 earnings per share for the current fiscal year.

Insider Activity at Urogen Pharma In other Urogen Pharma news, insider Mark Schoenberg sold 60,677 shares of the firm’s stock in a transaction dated Thursday, August 20th. The stock was sold at an average price of $47.05, for a total value of $2,854,852.85. Following the completion of the sale, the insider owned 59,086 shares of the company’s stock, valued at approximately $2,779,996.30. This trade represents a 50.66% decrease in their ownership of the stock. The sale was disclosed in a legal filing with the Securities & Exchange Commission, which can be accessed through the SEC website. In the last ninety days, insiders sold 85,899 shares of company stock worth $3,747,513. Corporate insiders own 4.80% of the company’s stock.

Urogen Pharma Profile (Free Report)

UroGen Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for uro-oncology and uro-genital diseases. Founded in 2010 and headquartered in Ra’anana, Israel, with offices in New York, UroGen applies its proprietary RTGel® reverse thermal gel delivery platform to create sustained-release formulations designed for in-office use by urologists.

The company’s lead product, Jelmyto® (mitomycin gel), received U.S. Food and Drug Administration approval in 2020 for the treatment of adults with low-grade upper tract urothelial cancer.

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Collaboration grants UroGen a research license and exclusive options to license and develop up to three oncology products utilizing IntraGel's proprietary SRGel platformAgreement also includes an exclusive option to acquire worldwide rights to TumoCure, an investigational therapy for advanced head and neck cancer PRINCETON, N.J., Aug. 20, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced a strategic Option and Research License Agreement (the Option Agreement) and a related equity investment agreement (the Investment Agreement) with IntraGel Therapeutics, Ltd. (IntraGel).

The Option Agreement includes two strategic components. First, UroGen gains access to IntraGel's proprietary SRGel platform, a biodegradable, sustained-release formulation technology designed for localized drug delivery, through a research license and options to obtain an exclusive, worldwide license to develop and commercialize up to three additional oncology products combining the SRGel platform with compounds to be designated by UroGen. Second, UroGen receives an exclusive option to obtain an exclusive, worldwide license to develop and commercialize TumoCure, IntraGel’s investigational therapy for advanced head and neck cancer, following IntraGel's completion of a Phase 2 clinical study.

"This Option Agreement represents an important step in expanding UroGen's oncology pipeline and technological capabilities," said Liz Barrett, President and Chief Executive Officer of UroGen. "IntraGel's biodegradable, sustained-release technology complements our expertise in local drug delivery while creating significant optionality for future innovation. Beyond the opportunity to advance TumoCure following a Phase 2 clinical study, we believe the SRGel technology could potentially enable multiple therapeutic approaches across a range of solid tumors and provide a foundation for new product opportunities over time."

In connection with the Option Agreement, UroGen has also entered into an Investment Agreement with IntraGel, pursuant to which UroGen will invest up to $7 million in the equity securities of IntraGel.

SRGel is a biodegradable depot technology designed to enable sustained local release of therapeutic agents over extended periods. The platform's flexibility supports multiple therapeutic modalities and has potential applicability across a broad range of solid tumor settings.

“UroGen’s leadership in localized oncology therapies and commercial-stage experience make them an ideal partner to help advance the SRGel platform and accelerate the development of TumoCure,” said Peter Siman, Ph.D., Chief Executive Officer and Co-Founder of IntraGel. “We see in this collaboration an important validation of the SRGel platform and the clinical potential of our lead product candidate, TumoCure, while creating a strong pathway to accelerate development across multiple oncology indications.”

TumoCure is an investigational cisplatin treatment formulated with IntraGel’s proprietary SRGel platform, designed to enable prolonged localized drug exposure while limiting systemic exposure.

Presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, early clinical data (N=8) showed that TumoCure was generally well tolerated in Phase 1b patients, showed low systemic cisplatin exposure, and provided early indications of anti-tumor activity in a heavily pretreated patient population, including patients with cisplatin treatment-resistant disease. Investigators also reported improvements in tumor-related symptoms in certain patients. These findings support continued clinical development of TumoCure and further expansion of the SRGel platform as a potential approach for sustained local therapy across additional solid tumors with the goal of minimizing systemic exposure.

About SRGel

SRGel is IntraGel’s proprietary injectable hydrophobic gel-like drug delivery platform designed to enable sustained drug release directly within solid tumors. Built on a proprietary water-free and solvent-free fatty-acids based polymer matrix, SRGel is engineered to provide controlled, and prolonged release of therapeutic agents following a single administration, with applicability for both localized delivery at the target site and sustained local exposure.

The technology is designed, when injected intratumorally, to maintain high local drug concentrations while minimizing systemic exposure and associated toxicities. SRGel has shown early indications of compatibility with a broad range of therapeutic modalities, including small molecules, peptides and biologics, and may be applicable across various therapeutic areas and indications, including weight loss management and inflammatory diseases.

About TumoCure

TumoCure is IntraGel’s lead product candidate and the first clinical application of the SRGel platform. TumoCure consists of cisplatin incorporated into the SRGel biodegradable matrix and is administered as a single intratumoral injection. The investigational therapy is designed to provide sustained delivery of cisplatin directly within tumor tissue over several months while limiting systemic exposure.

TumoCure is Phase 2-ready and is currently being developed for patients with locally advanced, inoperable head and neck cancers, who are ineligible for systemic cisplatin-based chemoradiation. IntraGel is pursuing development through the U.S. Federal Drug Administration (FDA)’s 505(b)(2) regulatory pathway and believes the technology may have future applicability across additional solid tumor indications, including lung, brain, gastrointestinal, ovarian and testicular cancers.

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. Our first product is approved to treat low-grade upper tract urothelial cancer, and our second product is approved for adult patients with recurrent LG-IR-NMIBC. Both products 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 of the Option Agreement with IntraGel; UroGen’s plans to evaluate, develop and potentially commercialize oncology products utilizing the SRGel platform; the potential therapeutic applications of the SRGel platform, including its ability to enable sustained local drug release, maintain high local drug concentrations and limit systemic exposure; the potential applicability of the SRGel platform across multiple therapeutic modalities, therapeutic areas and solid tumor settings, including weight loss management and inflammatory diseases; the intended performance and clinical development of TumoCure, including its potential to provide sustained delivery of cisplatin within tumor tissue while limiting systemic exposure; expectations regarding the continued clinical development of TumoCure, including the planned Phase 2 clinical study; IntraGel’s pursuit of the FDA’s 505(b)(2) regulatory pathway for TumoCure; the potential future applicability of TumoCure across additional solid tumor indications, including lung, brain, gastrointestinal, ovarian and testicular cancers; and the potential of UroGen’s RTGel platform technology to improve the therapeutic profiles of existing drugs and enable longer exposure of urinary tract tissue to medications. Words such as “anticipate,” “believe,” “could,” “may,” “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: 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, as well as the product candidates covered by the Option Agreement; there is no guarantee that the Option Agreement will yield any product candidates that UroGen determines have strategic value, and even if UroGen elects to exercise its option to obtain an exclusive license to one or more product candidates, there is no guarantee that any such products will receive regulatory approval; 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; 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 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

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

UroGen Pharma Ltd. (URGN) Q2 2026 Earnings Call Transcript

Urogen Pharma (URGN - Free Report) came out with a quarterly loss of $0.28 per share versus the Zacks Consensus Estimate of a loss of $0.38. This compares to a loss of $1.05 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of +26.32%. A quarter ago, it was expected that this company would post a loss of $0.56 per share when it actually produced a loss of $0.47, delivering a surprise of +16.07%.

Over the last four quarters, the company has surpassed consensus EPS estimates four times.

Urogen Pharma, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $72.46 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 16.42%. This compares to year-ago revenues of $24.22 million. The company has topped consensus revenue estimates three times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

Urogen Pharma shares have added about 70.5% since the beginning of the year versus the S&P 500's gain of 13%.

What's Next for Urogen Pharma?While Urogen Pharma has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Urogen Pharma was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.08 on $75.04 million in revenues for the coming quarter and -$0.76 on $275.7 million in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

Another stock from the same industry, Biofrontera Inc. (BFRI - Free Report) , has yet to report results for the quarter ended June 2026.

This company is expected to post quarterly loss of $0.17 per share in its upcoming report, which represents a year-over-year change of +70.2%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

Biofrontera Inc.'s revenues are expected to be $9 million, down 0.3% from the year-ago quarter.

PRINCETON, N.J., July 29, 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 second quarter 2026 financial results on Wednesday, August 5th, 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 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 is headquartered in Princeton, NJ with operations in Israel. Visit www.UroGen.com to learn more or follow us on X, @UroGenPharma.

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

1.18K Followers

Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

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.

Momentum investing revolves around the idea of following a stock's recent trend in either direction. In "long context," investors will be essentially be "buying high, but hoping to sell even higher." With this methodology, taking advantage of trends in a stock's price is key; once a stock establishes a course, it is more than likely to continue moving that way. The goal is that once a stock heads down a fixed path, it will lead to timely and profitable trades.

While many investors like to look for momentum in stocks, this can be very tough to define. There is a lot of debate surrounding which metrics are the best to focus on and which are poor quality indicators of future performance. The Zacks Momentum Style Score, part of the Zacks Style Scores, helps address this issue for us.

Below, we take a look at Urogen Pharma (URGN - Free Report) , which currently has a Momentum Style Score of A. We also discuss some of the main drivers of the Momentum Style Score, like price change and earnings estimate revisions.

It's also important to note that Style Scores work as a complement to the Zacks Rank, our stock rating system that has an impressive track record of outperformance. Urogen Pharma currently has a Zacks Rank of #2 (Buy). Our research shows that stocks rated Zacks Rank #1 (Strong Buy) and #2 (Buy) and Style Scores of "A or B" outperform the market over the following one-month period.

You can see the current list of Zacks #1 Rank Stocks here >>>

Set to Beat the Market?Let's discuss some of the components of the Momentum Style Score for URGN that show why this company shows promise as a solid momentum pick.

Looking at a stock's short-term price activity is a great way to gauge if it has momentum, since this can reflect both the current interest in a stock and if buyers or sellers have the upper hand at the moment. It's also helpful to compare a security to its industry; this can show investors the best companies in a particular area.

For URGN, shares are up 10.08% over the past week while the Zacks Medical - Biomedical and Genetics industry is up 2.27% over the same time period. Shares are looking quite well from a longer time frame too, as the monthly price change of 37.28% compares favorably with the industry's 10.3% performance as well.

While any stock can see a spike in price, it takes a real winner to consistently outperform the market. Shares of Urogen Pharma have increased 84.47% over the past quarter, and have gained 177.32% in the last year. In comparison, the S&P 500 has only moved 14.34% and 21.46%, respectively.

Investors should also pay attention to URGN's average 20-day trading volume. Volume is a useful item in many ways, and the 20-day average establishes a good price-to-volume baseline; a rising stock with above average volume is generally a bullish sign, whereas a declining stock on above average volume is typically bearish. URGN is currently averaging 643,028 shares for the last 20 days.

Earnings OutlookThe Zacks Momentum Style Score encompasses many things, including estimate revisions and a stock's price movement. Investors should note that earnings estimates are also significant to the Zacks Rank, and a nice path here can be promising. We have recently been noticing this with URGN.

Over the past two months, 2 earnings estimates moved higher compared to none lower for the full year. These revisions helped boost URGN's consensus estimate, increasing from -$1.13 to -$0.88 in the past 60 days. Looking at the next fiscal year, 2 estimates have moved upwards while there have been no downward revisions in the same time period.

Bottom LineGiven these factors, it shouldn't be surprising that URGN is a #2 (Buy) stock and boasts a Momentum Score of A. If you're looking for a fresh pick that's set to soar in the near-term, make sure to keep Urogen Pharma on your short list.

Mark Schoenberg, Chief Medical Officer of UroGen Pharma Ltd. (URGN +0.75%), reported the sale of 5,222 ordinary shares for a total of approximately $143,000, as disclosed in a SEC Form 4 filing.

Transaction summaryMetricValueShares sold (direct)5,222Transaction value$142,561Post-transaction shares (direct)139,763Post-transaction value (direct ownership)~$3.81 millionTransaction value based on SEC Form 4 weighted average purchase price ($27.30); post-transaction value based on the value of post-transaction holdings as reported in the Form 4.

Key questionsWhat is the derivative context of this transaction?
This filing reflects a two-step process: Schoenberg exercised 10,000 options, then immediately sold 5,222 shares for liquidity, with the remainder held as ordinary shares.How does this sale compare to Schoenberg's historical cadence and capacity?
Since May of last year, Schoenberg has made seven sell transactions; as his direct holdings have dropped by 25.81% over the period, average trade sizes have declined in line with reduced available share capacity.Does this transaction impact beneficial ownership or option exposure?
Following the sale, Schoenberg reports direct ownership of 139,763 shares and no remaining exercisable options, indicating all option-related equity has either been exercised or lapsed.What is the market context for the transaction?
Shares were sold at a weighted average price of around $27.30, near the open and close prices on June 8, 2026, amid a 168.23% one-year total return as of the transaction date.Company overviewMetricValueMarket capitalization1.45 billionRevenue (TTM)$140.49 millionNet income (TTM)-$133.23 million1-year price change147%*1-year performance calculated as of June 12, 2026.

Company snapshotOffers proprietary therapeutics for urinary tract cancers, including Jelmyto and a pipeline led by UGN-102 and UGN-301.Generates revenue through the commercialization of specialty oncology drugs, leveraging RTGel technology and strategic licensing agreements.Targets urologists, oncologists, and healthcare institutions treating patients with non-muscle invasive urothelial cancers.UroGen Pharma Ltd. operates as a biotechnology company focused on developing and commercializing innovative therapies for urinary tract cancers. The company leverages its proprietary RTGel platform and strategic partnerships to advance a pipeline of specialty oncology drugs targeting underserved patient populations.

With a strong emphasis on clinical development and commercialization, UroGen Pharma aims to address significant unmet medical needs in the urology and oncology sectors, positioning itself as a leader in the treatment of non-muscle invasive urothelial cancers.

What this transaction means for investorsWith 139,763 shares in his coffers following this transaction, Schoenberg’s interests are still aligned with investors. That said, investors probably want to tread lightly around UroGen Pharma stock. On June 2, the company settled with Teva Pharmaceuticals (TEVA +0.20%), a large generic drug manufacturer, regarding its generic version of Jelmyto. According to the terms, Teva will receive a non-exclusive license to sell generic Jelmyto beginning Sep. 15, 2030.

First-quarter Jelmyto sales rose 7% year over year to $21.7 million. The treatment was responsible for about 42.5% of total first-quarter revenue.

While Jelmyto could lose ground to generic competition in a few years, the company’s other mitomycin-based therapy, Zusduri, is working hard to offset the losses. First-quarter Zusduri sales jumped 109% higher year over year to $29.2 million.

Cory Renauer 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.

PRINCETON, N.J., April 08, 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 launch of its “LG-UTUC Luminaries” initiative, recognizing clinicians and institutions demonstrating leadership, expertise, and a commitment to advancing low‑grade upper tract urothelial cancer (LG‑UTUC) care.

LG‑UTUC is a rare form of cancer affecting an estimated 6,000-7,000 patients each year in the U.S., which represents approximately 40% of patients diagnosed in the U.S. annually with UTUC. While typically noninvasive, it often recurs and may require repeated endoscopic procedures or radical surgery to remove the kidney and ureter, underscoring a continued need for guideline-recommended kidney‑sparing care approaches.

“Through the LG-UTUC Luminaries initiative, we are honored to recognize the clinicians and institutions redefining what is possible for patients living with LG-UTUC,” said Liz Barrett, President and Chief Executive Officer of UroGen. “By elevating these leaders, we aim to inspire broader adoption of evidence-based, kidney-sparing care, strengthen collaboration across the urology community, and accelerate progress toward a future where patients with this highly recurrent disease have better outcomes and a better care experience.”

The LG-UTUC Luminaries initiative recognizes clinicians and institutions working to achieve excellence in LG-UTUC care. Honorees have extensive experience with LG-UTUC and are actively involved in treatment, research, and peer-to-peer education. Institutional recipients are distinguished by established, guideline-aligned care pathways spanning diagnosis, treatment, and long-term surveillance, as well as strong commitments to physician training, research participation, and comprehensive patient support.

UroGen recognizes Saum Ghodoussipour, MD, Director, Bladder and Urothelial Cancer Program, Rutgers Cancer Institute, and Associate Professor of Surgery, Rutgers Robert Wood Johnson Medical School, as the first recipient of this flagship LG-UTUC Luminaries recognition—an honor that will continue to be presented to physicians and institutions dedicated to helping shape the future of kidney-sparing management in LG-UTUC.

“I’m truly honored to receive this recognition,” said Dr. Saum Ghodoussipour, Director of the Bladder and Urothelial Cancer Program at Rutgers Cancer Institute and Associate Professor of Surgery at Rutgers Robert Wood Johnson Medical School, NJ. “This distinction reflects the dedication of our entire multidisciplinary team at Rutgers Cancer Institute, whose commitment to advancing education, research, and patient-centered care continues to drive progress for individuals living with LG-UTUC. I’d especially like to recognize Dr. Vignesh Packiam, Director of Clinical and Translational Research in Urologic Oncology and Associate Professor of Surgery at Rutgers Robert Wood Johnson Medical School, whose leadership and contributions have been instrumental in shaping our program. Together, we remain committed to improving outcomes through collaboration, innovation, and a steadfast focus on our patients.”

About the LG-UTUC Luminaries Initiative
The LG-UTUC Luminaries initiative is UroGen’s effort to recognize and collaborate with leading clinicians and institutions advancing care for patients with low-grade upper tract urothelial cancer. By highlighting clinical leadership and fostering collaboration across the urology community, the initiative supports continued progress in kidney-sparing care and efforts to improve outcomes in this rare and highly recurrent disease.

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 is headquartered in Princeton, NJ with operations in Israel. Visit www.UroGen.com to learn more or follow us on X, @UroGenPharma.

INVESTOR CONTACT:
Vincent Perrone
[email protected]
(609) 460-3588 Ext. 1093

MEDIA CONTACT:
Cindy Romano
[email protected]
(609) 460-3566 Ext. 1083

ZUSDURI™ generated revenue of $29.2 million in Q1 2026, representing 109% quarter-over-quarter growth, reflecting broader utilization with the permanent J Code effective January 1, 2026JELMYTO achieved $21.7 million in revenue in Q1 2026, representing year-over-year growth of 7%Continued advancement of next-generation pipeline, UGN-103 on track for NDA submission in the second half of 2026; six-month durability data expected in mid-2026UroGen to host Key Opinion Leader (KOL) panel highlighting real-world experience with ZUSDURI at the American Urological Association (AUA) annual meeting on May 17th at 8:30 AM ETConference call and webcast to be held today at 10:00 AM ET PRINCETON, N.J., May 06, 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 first quarter ended March 31, 2026, and provided an overview of recent developments.

“2026 is off to a strong start, with expanding usage of ZUSDURI™ (mitomycin) for intravesical solution and clear acceleration across key commercial indicators, including prescriber trial and adoption,” said Liz Barrett, President and Chief Executive Officer of UroGen. “These trends reflect growing clinical confidence in ZUSDURI as a primary, non-surgical therapy for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The early launch momentum is now translating into meaningful revenue growth, providing early validation of our commercial model and reinforcing the blockbuster potential for ZUSDURI. In parallel, we continue to advance our broader pipeline, including next generation products UGN-103 in LG-IR-NMIBC and UGN-104 in low-grade upper tract urothelial carcinoma (LG-UTUC), as well as UGN-501, our investigational, potentially best-in-class, next-generation oncolytic virus. With this momentum, we are well positioned to execute our long-term growth strategy and continue to expand our leadership position in uro-oncology.”

Q1 2026 and Recent Business Highlights:

ZUSDURI (mitomycin) for intravesical solution:

Commercial launch of ZUSDURI continues to accelerate, following its U.S. FDA-approval as the first and only FDA-approved medicine for adults with recurrent LG-IR-NMIBC.The permanent Healthcare Common Procedure Coding System Level II J Code (J9282) became effective on January 1, 2026 and has enabled broader adoption by improving reimbursement clarity and confidence across both hospital and community settings.ZUSDURI achieved net product revenue of $29.2 million in the first quarter of 2026, representing 109% quarter-over-quarter growth. The accelerating growth trend in prescribers, particularly repeat prescribers, reflects increasing health care provider confidence and successful integration of ZUSDURI into routine urology practice. As of March 31, 2026, UroGen reported: 972 activated sites of care256 unique ZUSDURI prescribers103 repeat ZUSDURI prescribers Updated results from the Phase 3 ENVISION trial evaluating ZUSDURI were published online ahead of print in the Journal of Urology. The publication reported that patients who achieved a complete response (CR) three months after the first instillation of ZUSDURI had a 72.2% probability of remaining event-free 24 months after CR (95% CI: 64.1%, 78.8%) as determined by Kaplan-Meier analysis.
JELMYTO (mitomycin) for pyelocalyceal solution in LG-UTUC:

Generated net product revenue of $21.7 million in the quarter ended March 31, 2026, an increase of approximately 7% over the $20.3 million reported for first quarter of 2025.
Next-generation novel mitomycin-based formulations for urothelial cancer

UroGen plans to submit a New Drug Application (NDA) for UGN-103 (mitomycin) for recurrent LG-IR-NMIBC in the second half of 2026 with potential FDA approval in 2027. The FDA has agreed with the Company’s regulatory plan to submit the NDA based on the data from the Phase 3 UTOPIA trial. Top line results from UTOPIA were reported in November 2025, demonstrating a 77.8% three-month CR rate (95% CI, 68.3%, 85.5%). For more information on the UTOPIA trial, refer to clinicaltrials.gov/NCT06331299.UGN-103 is a next-generation mitomycin product designed to offer improvements over ZUSDURI, including a shorter manufacturing process and simplified reconstitution procedure. It combines UroGen’s RTGel® technology with a novel mitomycin formulation licensed from medac. UroGen continues to evaluate lifecycle management and pipeline expansion opportunities, including potential applications in high-grade NMIBC settings and adjuvant use of UGN-103 in IR-NMIBC patients.The Phase 3 clinical trial to explore the safety and efficacy of UGN-104 is ongoing and is expected to be fully enrolled by the end of 2026. UGN-104 is a next-generation mitomycin product for LG-UTUC. For more information on the UGN-104 Phase 3 trial (UT002), refer to https://clinicaltrials.gov/study/NCT06774131.
UGN-501 (investigational next-gen oncolytic virus) for use in high-grade non-muscle invasive bladder cancer

UGN-501 is a potent and fast-replicating investigational next-generation oncolytic virus being developed as a locally administered cancer treatment. Investigational New Drug (IND)-enabling studies are nearing completion, and UroGen plans to submit an IND in the second quarter of 2026 and initiate a Phase 1 clinical trial in NMIBC by year end. Nonclinical data to date demonstrate cytotoxic activity across a panel of bladder cancer cell lines representing a broad range of tumor stages and grades. The Phase 1 trial will initially evaluate aqueous intravesical administration of UGN-501, and UroGen plans to evaluate delivery using its proprietary RTGel technology, which may enable prolonged dwell time and enhanced local activity. The initial focus is bladder cancer with the potential to expand into additional tumor types beyond the genitourinary system.
Expanded Debt Facility with Pharmakon Advisors

In February 2026, UroGen entered into an amended and restated loan agreement with Pharmakon Advisors for two additional tranches of senior secured term loans. The first tranche of $200 million was funded at closing to refinance the existing $125 million loan facility and provide additional non-dilutive capital. A second tranche of $50 million may be drawn at the Company's option no later than June 30, 2027, subject to customary conditions. All outstanding loans with Pharmakon Advisors will accrue interest at a fixed rate of 8.25% and be repaid in four equal quarterly payments commencing in the second quarter of 2030. All outstanding loans with Pharmakon Advisors can be prepaid in whole at UroGen's discretion at any time, subject to prepayment premiums, make-whole amounts, as applicable, and fees.
American Urological Association Key Opinion Leader Panel to Showcase Real-World Experience with ZUSDURI

UroGen will host a KOL panel at the upcoming AUA Annual Meeting focused on real-world experience with ZUSDURI, including patient selection, workflow integration, treatment patterns, and patient outcomes. The event will feature leading urologists highlighting the role of ZUSDURI as a primary, non-surgical treatment option in recurrent low-grade intermediate-risk NMIBC and will be webcast and accessible through the Company’s website. To register click here.
First quarter 2026 Financial Results

Revenue: Total revenue was $51.0 million in the first quarter ended March 31, 2026, compared with $20.3 million in the first quarter of 2025. Year-over-year revenue growth of 152% was primarily driven by the commercial launch of ZUSDURI and JELMYTO revenue growth.

Research and Development (R&D) Expenses: R&D expenses were $15.6 million in the first quarter of 2026, including non-cash share-based compensation expense of $0.8 million. This compares to $19.9 million, including non-cash share-based compensation expense of $0.6 million, for the same period in 2025. The decrease in R&D expenses was primarily attributable to the acquisition of UGN-501 in the first quarter of 2025 and ZUSDURI manufacturing costs, which were recognized as R&D expense in the first quarter of 2025 prior to receiving FDA approval.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $51.5 million in the first quarter of 2026, including non-cash share-based compensation expense of $3.9 million. This compares to $35.0 million, including non-cash share-based compensation expense of $2.5 million, for 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, an increase in overall commercial operation costs, and higher advisory costs, including fees associated with the Pharmakon Advisors debt refinancing in the first quarter of 2026.

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 first 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 $4.2 million in the first quarter of 2026, compared to $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 $23.6 million or ($0.47) per basic and diluted share in the quarter ended March 31, 2026, compared with a net loss of $43.8 million or ($0.92) per basic and diluted share in the first quarter of 2025.

Cash, Cash Equivalents and Marketable Securities: As of March 31, 2026, cash, cash equivalents and marketable securities totaled $140.3 million.

2026 JELMYTO Revenue and 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 continues to expect full-year 2026 operating expenses to be in the range of $240 million to $250 million, including non-cash share-based compensation expense of $20 million to $24 million.

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 http://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)            March 31, 2026 December 31, 2025Cash and cash equivalents and marketable securities $140,274  $120,456 Total assets $253,690  $200,455 Total liabilities $377,943  $305,929 Total shareholders' deficit $(124,253) $(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 March 31,  2026   2025     Revenue$50,959  $20,254 Cost of revenue 4,139   2,330 Gross profit 46,820   17,924 Operating expenses:   Research and development expenses 15,597   19,871 Selling, general and administrative expenses 51,486   34,967 Total operating expenses 67,083   54,838 Operating loss (20,263)  (36,914)Financing on prepaid forward obligation (4,506)  (4,583)Interest expense on long-term debt (4,185)  (4,068)Interest and other income, net 608   2,114 Loss before income taxes$(28,346) $(43,451)Income tax benefit (expense) 4,772   (392)Net loss$(23,574) $(43,843)Net loss per ordinary share, basic and diluted$(0.47) $(0.92)Weighted average shares outstanding, basic and diluted 50,182,758   47,422,119      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 indicated for the treatment of adult patients with LG-UTUC. It is recommended for primary treatment of biopsy-proven LG-UTUC in patients deemed appropriate candidates for renal-sparing therapy. 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 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 chemoablative 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 adults 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 for ZUSDURI as a primary, non-surgical therapy for adults with recurrent LG-IR-NMIBC; ZUSDURI’s accelerating commercial uptake and growing rates of prescriber trial and adoption; the belief that growing clinical confidence in ZUSDURI will continue to drive commercial momentum and that the early launch trajectory provides validation of UroGen's commercial model; the belief in the significant commercial opportunity for ZUSDURI and UroGen’s ability to fully capitalize on it; the potential benefits and opportunities for UroGen’s product candidates, including UGN-103, UGN-104 and UGN-501; UroGen’s planned and ongoing clinical trials and IND-enabling studies and the timing for regulatory submissions and potential regulatory approvals for its product candidates, including the ongoing Phase 3 UTOPIA clinical trial of UGN-103, the ongoing Phase 3 clinical trial of UGN-104 and the IND-enabling studies of UGN-501, the planned NDA submission for UGN-103 and the potential regulatory approval thereof and the planned IND submission for UGN-501 and the potential Phase 1 trial thereof; the potential of UGN-501 to expand into additional tumor types beyond the genitourinary system; the expectation that UroGen’s next-generation medicines will enhance supply, improve manufacturing and preparation efficiencies and provide opportunity for lifecycle extensions; 2026 JELMYTO revenue and company operating expense guidance; the expected timeline of UroGen’s expanded debt facility with Pharmakon Advisors; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs other than mitomycin and as a viable platform for local delivery of complex immunotherapies; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. Words such as “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 Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 2, 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

UroGen Pharma Ltd. (URGN) Q1 2026 Earnings Call Transcript

UroGen Pharma is reaffirmed as a Strong Buy, with a 12-month price target raised to $39/share, reflecting robust Q1 2026 results. Zusduri sales more than doubled QoQ to $29.2M, driven by the January J-code assignment, validating the trajectory toward profitability by 2027. URGN's path to profitability is underpinned by >91% gross margins, disciplined expense control, and a realistic break-even threshold of $305M annual revenue.

64.5% Probability of Remaining Event-Free at Three Years by Kaplan-Meier Analysis After Achieving Complete Response at Three MonthsFirst and Only FDA-Approved Medicine for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer PRINCETON, N.J., May 13, 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 a 36-month duration of response (DOR) of 64.5% (95% CI, 54.6% - 72.8%) by Kaplan-Meier estimate in patients who achieved a complete response (CR) at three months (79.6%) in the pivotal Phase 3 ENVISION trial of ZUSDURI™ (mitomycin) for intravesical solution. At a median follow-up of 35.5 months, the median DOR had not been reached. These data demonstrate that a substantial proportion of complete responders remained disease-free at three years, and durable outcomes were achieved without the need for maintenance therapy.

“This update from the pivotal ENVISION trial shows that many patients who achieve a complete response with ZUSDURI remain disease-free through three years,” said Sandip Prasad, M.D., M.Phil., Director of Genitourinary Surgical Oncology and Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, NJ, and Principal Investigator of the ENVISION trial. “Among patients who achieved a complete response, the event rate over time has remained stable. Importantly, ZUSDURI’s durability was achieved without maintenance therapy, supporting a treatment approach that can provide lasting disease control while reducing ongoing treatment burden for patients.”

As a non-surgical, in-office treatment, ZUSDURI offers patients an opportunity to achieve meaningful disease- and treatment-free living without the burden of repeated TURBT procedures under general anesthesia. The current standard of care for LG-IR-NMIBC is transurethral resection of bladder tumor (TURBT), a surgical procedure typically performed under general anesthesia. Due to high recurrence rates following surgery, patients often undergo multiple TURBTs over their lifetime, leading to a cycle of repeat procedures that can impact quality of life and increase cumulative risk, particularly in older patients with comorbidities. An estimated 59,000 patients with LG-IR-NMIBC recur annually.

“The ENVISION 36-month DOR data reinforce ZUSDURI’s potential to shift the treatment paradigm for recurrent LG-IR-NMIBC,” said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. “By delivering durable responses without maintenance therapy, ZUSDURI provides an opportunity to move beyond the cycle of repeated surgical interventions and toward a more durable, lower-burden treatment approach over time.”

The most common (≥ 10%) adverse reactions (ARs), including laboratory abnormalities, that occurred in patients were dysuria, increased potassium, increased creatinine, decreased hemoglobin, increased eosinophils, increased aspartate aminotransferase, increased alanine aminotransferase, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. ARs were mainly mild to moderate. Serious ARs occurred in 12% of patients, including urinary retention (0.8%) and urethral stenosis (0.4%).

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 recurrent. 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 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 non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.

About ENVISION
The Phase 3 ENVISION trial is a single-arm, multinational, multicenter pivotal study evaluating the efficacy and safety of ZUSDURI (mitomycin) for intravesical solution as a chemoablative therapy in adult patients with recurrent LG-IR-NMIBC. The Phase 3 ENVISION trial completed target enrollment with 240 patients across 56 sites. Study participants received six once-weekly intravesical instillations of ZUSDURI. The primary endpoint evaluated the CR rate three months after the first instillation, and the key secondary endpoint evaluates durability over time in patients who achieved a CR at the three-month assessment. Learn more about the Phase 3 ENVISION trial at www.clinicaltrials.gov (NCT05243550).

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. Our first product to treat low-grade upper tract urothelial cancer and our second product, ZUSDURI (mitomycin) for intravesical solution for adult 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 (Twitter), @UroGenPharma.

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 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 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, 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.

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 of ZUSDURI, including as an outpatient treatment option, its potential to provide durable CRs without maintenance therapy and clinically meaningful disease- and recurrence-free intervals; the potential of ZUSDURI to shift the treatment paradigm and provide a compelling non-surgical alternative to TURBT for the treatment of recurrent LG-IR-NMIBC; the estimated annual U.S. patient population and demographics for LG-IR-NMIBC; the ongoing Phase 3 ENVISION trial; 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,” “estimate,” “likely,” “may,” “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; 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; 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 being filed with the SEC on May 6, 2026, 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

PRINCETON, N.J., May 15, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company focused on transforming the treatment of urothelial and specialty cancers, today announced UGN-103 achieved a 94.5% (95% CI: 86.1, 97.9) durability of response (DOR) at six months by Kaplan-Meier estimate, in the ongoing Phase 3 UTOPIA trial of UGN-103 (mitomycin) for intravesical solution in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (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 observed with ZUSDURI™ (mitomycin) for intravesical therapy in its pivotal ENVISION trial. ZUSDURI is the first and only treatment approved by the U.S. Food and Drug Administration (FDA) for adult patients with recurrent LG-IR-NMIBC.

Based on the consistency of UTOPIA data with the results of the ENVISION trial studying ZUSDURI in patients meeting the same eligibility criteria and alignment with the FDA, UroGen remains on track to submit a New Drug Application (NDA) for UGN-103 in the third quarter of 2026.

“The durability of response observed at six months with UGN-103 in the UTOPIA trial is generally consistent with that observed in the pivotal ENVISION trial of ZUSDURI, and highlights the potential to further advance care for adult patients with recurrent LG-IR-NMIBC,” said Abishek Srivastava, MD, Urologic Oncologist at Atlantic Urology Clinics, Myrtle Beach, SC, START Center for Cancer Research, Carolinas and lead investigator of the UTOPIA trial. “UGN-103 builds on a proven therapeutic approach with meaningful innovations that could help enhance how we deliver this therapy in clinical practice.”

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.

“These clinical data reinforce the potential of UGN-103 to become a new standard of care for adult patients with recurrent LG-IR-NMIBC,” said Liz Barrett, President and Chief Executive Officer of UroGen. “With FDA alignment on our regulatory path, we are advancing with urgency toward NDA submission. We believe UGN-103 represents a significant opportunity to build on our leadership in uro-oncology, expand our commercial portfolio, and drive long-term growth.”

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 protection expected to extend into December 2041.

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 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 extend the clinical and commercial profile 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 protection expected to extend into December 2041.

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 recurrent. 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 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. Our first product is approved to treat low-grade upper tract urothelial cancer, and our second product, ZUSDURI (mitomycin) for intravesical solution, is approved for adult patients with recurrent LG-IR-NMIBC. Both products 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.

About medac CDMO
The belief that health is humanity’s most valuable resource drives medac group. Since 1970, the mission of medac has been to improve patients’ quality of life worldwide by making the best medical treatments available. Since 2000, medac has been dedicated to improving patient outcomes globally by supporting pharmaceutical companies in bringing the best medical treatments to market. As a trusted Contract Development and Manufacturing Organization (CDMO), headquartered in Germany, medac CDMO is specialised in providing customised, high-quality services to customers and worldwide markets.

With a team of over 2,000 highly skilled professionals, medac CDMO offers comprehensive solutions tailored to the needs of clients worldwide. The cutting-edge facilities of medac group in Germany and the Czech Republic are equipped with the latest technologies to ensure precision, efficiency and compliance with the most stringent industry standards. From early-stage development to large-scale commercial production, medac CDMO is committed to foresight, progress, reliability and creative thinking which makes them a solution ahead.

The deep expertise, commitment to quality and flexible manufacturing capabilities enable medac CDMO to serve as a trusted partner for pharmaceutical and biotech companies looking to scale their operations and bring life-changing treatments to patients around the globe.

For more information, please visit www.medac-cdmo.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 previously receiving bladder surgery to remove 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 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, 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.

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 for the Phase 3 UTOPIA trial to support an NDA submission for UGN-103 and the planned timing thereof; the potential path toward approval of UGN-103 and potential approval thereof; the potential of UGN-103 to advance care for and provide benefits to adult patients with recurrent LG-IR-NMIBC and become a new standard of care; the potential of UGN-103 to build on UroGen’s leadership in uro-oncology, expand its commercial portfolio, and drive long-term growth; the potential benefits of UGN-103 as compared to ZUSDURI, including its streamlined manufacturing and reconstitution processes and expected intellectual property protection; 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 “believe,” “can,” “estimated,” “expect,” “may,” “plan,” “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 our 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. 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, 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

PRINCETON, N.J., June 01, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company focused on transforming the treatment of urothelial and specialty cancers, today announced that management will present at the Goldman Sachs 47th Annual Global Healthcare Conference to take place on June 8-10, 2026.

Goldman Sachs 47th Annual Global Healthcare Conference

Date / Time:June 10, 2026, at 8:40 AM ETFormat:Fireside chat and 1x1 investor meetingsLocation:Miami Beach, FLWebcast Link:here
The webcast from the conference will also be available on UroGen’s corporate website, under Events & Presentations. A replay will be available for approximately 90 days.

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. Our first product is approved to treat low-grade upper tract urothelial cancer, and our second product is approved for adult patients with recurrent LG-IR-NMIBC. Both products 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.

INVESTORS:

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

PRINCETON, N.J., June 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 the grants of inducement restricted stock units (“RSUs”) to 21 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of JELMYTO® (mitomycin) for pyelocalyceal solution and ZUSDURITM (mitomycin) for intravesical solution, UroGen’s only approved products, and the continued development of UroGen’s pipeline.

Up to 102,700 ordinary shares of UroGen are issuable upon the vesting and settlement of the RSUs. The RSUs will vest equally over three years, with one-third of the underlying shares vesting each year on the anniversary of the vesting date, subject in each case to the employee’s continued service relationship with UroGen.

The RSUs are subject to the terms and conditions of UroGen’s 2019 Inducement Plan and RSU grant notice and agreement thereunder. The RSUs were granted as an inducement material to each employee entering into employment with UroGen in accordance with Nasdaq Listing Rule 5635(c)(4).

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 commercial product is approved to treat low-grade upper tract urothelial cancer, and UroGen’s second product is the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Both medicines are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, New Jersey with operations in Israel. To learn more, visit www.urogen.com or follow us on X, @UroGenPharma.

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

INVESTOR CONTACT:
Vincent Perrone
[email protected]
(609) 460-3588 Ext. 1093

MEDIA CONTACT:
Cindy Romano
[email protected]
(609) 460-3566 Ext. 1083