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URGN on Nasdaq

UroGen Pharma Ltd.

In its 2026 annual report the company says: “We are a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers. We have developed RTGel reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based technology that has the potential to improve therapeutic profiles of existing drugs. Our technology is designed to enable longer exposure of urinary tract tissue to medications, making local therapy a potentially more effective treatment option.”3 Its shares trade on Nasdaq under the symbol URGN.1

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Last updated Oct 21, 2026.

Overview

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  • TickerURGN on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersL31
  • Incorporated inIsrael2
  • Business address9 Ha'Ta'Asiya St, Ra'Anana, L3 43650072
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

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We are a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers. We have developed RTGel reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based technology that has the potential to improve therapeutic profiles of existing drugs. Our technology is designed to enable longer exposure of urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our approved products Jelmyto (mitomycin) for pyelocalyceal solution and Zusduri (mitomycin) for intravesical solution are designed to ablate tumors by non-surgical means and to treat several forms of non-muscle invasive urothelial cancer, including low-grade upper tract urothelial cancer (“low-grade UTUC”) and recurrent low-grade intermediate risk non-muscle invasive bladder cancer (“low-grade intermediate risk…3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

88.7%Gross margin4
-113.7%Operating margin4
-139.8%Net margin4
21.4%Revenue growth, 20254
-$162.7MFree cash flow4

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Jelmyto brought in 86% of the revenue UroGen Pharma Ltd. broke down this way in fiscal 2025.

  1. Jelmyto$94.0M486%up 4% from 2024
  2. Zusduri$15.8M414%
Products and services by year
Products and services20242025
Jelmyto$90.4M$94.0M
Zusduri$0$15.8M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue5¢$12.4M
  • Research and development29¢$67.1M
  • Selling, general and admin66¢$155.1M
  • Income tax0¢$78.0K

Out of $109.8M in revenue.4 The company lost money this year.

Financial statements

Revenue567894$109.8M in 2025+609833% since 2019
0$50.0M$100.0M$150.0M2019: $18.0K$18.0K20192020: $11.8M$11.8M2020+65450%2021: $48.0M$48.0M2021+307%2022: $64.4M$64.4M2022+34%2023: $82.7M$82.7M2023+29%2024: $90.4M$90.4M2024+9%2025: $109.8M$109.8M2025+21%
Gross profit567894$97.3M in 2025+540683% since 2019
0$25.0M$50.0M$75.0M$100.0M2019: $18.0K$18.0K20192020: $10.8M$10.8M2020+59844%2021: $42.9M$42.9M2021+297%2022: $56.7M$56.7M2022+32%2023: $73.4M$73.4M2023+29%2024: $81.5M$81.5M2024+11%2025: $97.3M$97.3M2025+19%
Operating income567894-$124.9M in 2025+14% since 2019
-$150.0M-$100.0M-$50.0M02019: -$109.5M-$109.5M20192020: -$126.7M-$126.7M2020+16%2021: -$92.3M-$92.3M2021−27%2022: -$79.0M-$79.0M2022−14%2023: -$65.5M-$65.5M2023−17%2024: -$96.8M-$96.8M2024+48%2025: -$124.9M-$124.9M2025+29%
Net income567894-$153.5M in 2025+46% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$105.1M-$105.1M20192020: -$128.5M-$128.5M2020+22%2021: -$110.8M-$110.8M2021−14%2022: -$109.8M-$109.8M2022−1%2023: -$102.2M-$102.2M2023−7%2024: -$126.9M-$126.9M2024+24%2025: -$153.5M-$153.5M2025+21%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Revenue$109.8M$90.4M
Cost of revenue$12.4M$8.9M
Gross profit$97.3M$81.5M
Research and development expenses$67.1M$57.1M
Selling, general and administrative expenses$155.1M$121.2M
Operating loss-$124.9M-$96.8M
Financing on prepaid forward obligation-$18.5M-$23.4M
Interest expense on long-term debt-$15.3M-$12.5M
Interest and other income, net$5.3M$8.7M
Loss before income taxes-$153.4M-$124.0M
Income tax expense-$78.0K-$2.8M
Net Loss-$153.5M-$126.9M
Unrealized income (loss) on investments-$37.0K$44.0K
Comprehensive Loss-$153.5M-$126.8M
Net loss per ordinary share - basic and diluted (in dollars per share)-$3.19-$2.96
Weighted average number of shares outstanding used in computation of basic and diluted loss per ordinary share (in shares)48.1M shares42.9M shares

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Corporate structure

UroGen Pharma Ltd. sits at the top of its group. 1 entity on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of UroGen Pharma Ltd.

  • UroGen Pharma Ltd. L3

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What UroGen Pharma Ltd. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$5.2M4 Dec 31, 2025$4.9M4 Dec 31, 2024+5.8%
Accumulated depreciation$4.6M4 Dec 31, 2025$4.3M4 Dec 31, 2024+7.1%
Property and equipment, net$637.0K4 Dec 31, 2025$655.0K4 Dec 31, 2024−2.7%
Finance-lease assets$5.4M4 Dec 31, 2025$2.3M4 Dec 31, 2024+135.3%
Operating-lease assets (leased space)$3.1M4 Dec 31, 2025$849.0K4 Dec 31, 2024+262.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$110.7M4 Dec 31, 2025$172.0M4 Dec 31, 2024−35.6%
Marketable securities, current$49.3M4 Dec 31, 2025$110.7M4 Dec 31, 2024−55.4%
Marketable securities, non-current$04 Dec 31, 2025$5.0M4 Dec 31, 2024−100.0%
Debt securities available for sale$9.7M4 Dec 31, 2025$69.7M4 Dec 31, 2024−86.1%

Inventory

ItemLatestA year beforeChange
Inventory, total$16.5M4 Dec 31, 2025$9.2M4 Dec 31, 2024+78.4%
Raw materials$11.0M4 Dec 31, 2025$4.9M4 Dec 31, 2024+124.2%
Finished goods$5.4M4 Dec 31, 2025$4.5M4 Dec 31, 2024+19.9%

Properties, in its own words

We lease approximately 20,913 square feet of space in Princeton, NJ, which serves as our principal executive offices and is used for commercial and marketing as well as general and administrative purposes. We lease an approximately 11,495 square foot facility in Israel, which is used primarily as research and development laboratories as well as for administrative purposes. We believe that our existing facilities are adequate to meet our current needs, and that suitable additional or alternative spaces will be available in the future on commercially reasonable terms.

Item 2 of the 10-K filed Mar 2, 2026.3

Leadership

Who has led UroGen Pharma Ltd., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Ron Bentsur2019

Chief financial officer

  1. Peter P. Pfreundschuh2019–2020
  2. Molly Henderson2020–2022
  3. Chris Degnan2024–now

Chief operating officer

  1. Stephen Mullennix2019–2020
20202025
Board members and other officers (11)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerDon Kim named Aug 14, 202327
  • Executive Officer, DirectorElizabeth Barrett named Aug 14, 202327
  • Executive OfficerJason A. Smith named Aug 14, 202327
  • DirectorJames A. Robinson, Jr. named Aug 14, 202327
  • DirectorLeana Wen, M.D., MSc named Aug 14, 202327

Timeline

  1. Aug 20, 20268-K Other events28
  2. Aug 5, 20268-K Results of operations29
  3. Jun 23, 20268-K Change to shareholders' rights; Executive or director change; Shareholder vote30
  4. Jun 2, 20268-K Other events31
  5. May 6, 20268-K Results of operations32
  6. Mar 2, 20268-K Entered a material agreement; New debt or obligation33
  7. Mar 2, 20268-K Results of operations34
  8. Nov 6, 20258-K Results of operations35
  9. Aug 27, 20258-K Executive or director change; Shareholder vote36
  10. Aug 7, 20258-K Results of operations37
  11. Jul 3, 20258-K Executive or director change38
  12. Jun 13, 20258-K Other events39
  13. Jan 10, 2019New chief executive Ron Bentsur becomes CEO12

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.69) a share, on Nov 6, 2025.40

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results29
  2. May 6, 2026Reported quarterly or annual results32
  3. Mar 2, 2026Reported quarterly or annual results34
  4. Nov 6, 2025Reported quarterly or annual results35
  5. Aug 7, 2025Reported quarterly or annual results37
  6. May 12, 2025Reported quarterly or annual results41
  7. Mar 10, 2025Reported quarterly or annual results42
  8. Nov 6, 2024Reported quarterly or annual results43

Drug trials and FDA: coming up

  1. Mar 2027Phase 3 trial readout expected Phase 3 trial of UGN-104 in Upper Urinary Tract Urothelial Carcinoma: primary completion expected Mar 2027 (ClinicalTrials.gov NCT06774131).44

Drug trials and FDA: recently

  1. Sep 11, 2025Phase 3 trial completed Phase 3 trial of UGN-103 in Bladder Cancer: primary completion Sep 11, 2025, results posted Sep 28, 2026 (ClinicalTrials.gov NCT06331299).45
  2. Jun 12, 2025FDA approval FDA approved Zusduri (mitomycin) (NDA 215793).46
  3. May 20, 2025FDA advisory committee The FDA's Oncologic Drugs Advisory Committee met to discuss (mitomycin) intravesical solution (NDA 215793), submitted by UroGen Pharma, Inc.47

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

304 filings to the SEC since October 2021: 8 annual reports, 15 quarterly reports, 50 major events, 121 insider forms, 54 large holders, 1 private raises, 55 other. The latest 20:

  1. Oct 9, 2026144 EDGAR
  2. Oct 9, 20264 EDGAR
  3. Sep 9, 2026144 EDGAR
  4. Sep 9, 2026144 EDGAR
  5. Sep 9, 20264 EDGAR
  6. Sep 9, 20264 EDGAR
  7. Aug 28, 20264 EDGAR
  8. Aug 24, 20264 EDGAR
  9. Aug 20, 20268-K EDGAR
  10. Aug 20, 2026144 EDGAR
  11. Aug 12, 2026SCHEDULE 13G/A EDGAR
  12. Aug 5, 202610-Q EDGAR
  13. Aug 5, 20268-K EDGAR
  14. Jul 10, 20264 EDGAR
  15. Jul 9, 2026144 EDGAR
  16. Jun 24, 20264 EDGAR
  17. Jun 24, 20264 EDGAR
  18. Jun 24, 20264 EDGAR
  19. Jun 24, 20264 EDGAR
  20. Jun 24, 20264 EDGAR

The 304 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

45 open-market trades by officers, directors and large owners since October 2021: 1 buys and 44 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 8, 2026Schoenberg MarkChief Medical OfficerSale871$42.92$37.4KForm 4
Sep 8, 2026Smith Jason DrewGeneral CounselSale1,519$42.54$64.6KForm 4
Aug 20, 2026Schoenberg MarkChief Medical OfficerSale60,677$47.05$2.9MForm 4
Jul 9, 2026Schoenberg MarkChief Medical OfficerSale10,000$40.00$400.0KForm 4
Jun 22, 2026Schoenberg MarkChief Medical OfficerSale10,000$35.01$350.1KForm 4
Jun 8, 2026Schoenberg MarkChief Medical OfficerSale5,222$27.30$142.6KForm 4
May 8, 2026Schoenberg MarkChief Medical OfficerSale10,000$30.00$300.0KForm 4
Feb 3, 2026Smith Jason DrewGeneral CounselSale7,479$19.69$147.3KForm 4
Feb 3, 2026Schoenberg MarkChief Medical OfficerSale7,373$19.69$145.2KForm 4
Nov 19, 2025Schoenberg MarkChief Medical OfficerSale10,000$25.00$250.0KForm 4
Oct 8, 2025Degnan ChrisChief Financial OfficerSale2,203$16.85$37.1KForm 4
Sep 8, 2025Schoenberg MarkChief Medical OfficerSale871$19.11$16.6KForm 4
Sep 8, 2025Smith Jason DrewGeneral CounselSale1,520$19.11$29.0KForm 4
Aug 11, 2025Schoenberg MarkChief Medical OfficerSale10,000$17.69$176.9KForm 4
Jul 28, 2025Smith Jason DrewGeneral CounselSale7,522$19.14$144.0KForm 4
Jul 28, 2025Schoenberg MarkChief Medical OfficerSale5,149$19.14$98.6KForm 4
Jun 9, 2025Schoenberg MarkChief Medical OfficerSale5,162$7.37$38.0KForm 4
Jan 31, 2025Schoenberg MarkChief Medical OfficerSale4,551$11.14$50.7KForm 4
Jan 31, 2025Smith Jason DrewGeneral CounselSale7,379$11.14$82.2KForm 4
Sep 9, 2024Schoenberg MarkChief Medical OfficerSale859$13.08$11.2KForm 4

All 45 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Elizabeth Barrett63$855.6K$4.3M68
2025Jason Smith54$492.0K$1.2M68
2025Mark Schoenberg68$369.6K$1.2M68
2024Chief Executive Officer$826.0K$4.1M68
2024General Counsel and Chief Compliance Officer$475.0K$1.3M68
2024Chief MedicalOfficer$354.2K$878.9K68

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$120.0M 2023–2023
Money received by yearMoney received by year, 2023–2023: $120.0M in all. Private raises (Form D) $120.0M.$0$50M$100M$150M2023 · Private raises (Form D): $120.0M2023
Figures by year
YearPrivate raises (Form D)Total
2023$120.0M$120.0M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Jul 26, 2023Raised $120 million in a private offering of equity27 Form D: 8 investors so far Form D

SEC filer profile

How UroGen Pharma Ltd. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARUroGen Pharma Ltd.1
  • CIK0001668243
  • Employer ID (EIN)98-14607463
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inIsrael3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address9 Ha'Ta'Asiya St, Ra'Anana, L3 43650071
  • Phone972 9 770 76011
  • Shares outstanding48,880,564 as of Jul 28, 202611
  • Public float$620.4M as of Jun 30, 20253
  • AuditorPricewaterhouseCoopers LLP, Florham Park, New Jersey PCAOB ID 238; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceMar 4, 20161
  • Filings579 in all: 4 (196), 8-K (84), SC 13G/A (32), 6-K (27), 10-Q (23), 144 (20), 3 (20), SC 13G (20)1
    All 42 form types

    SCHEDULE 13G/A (14), UPLOAD (14), 4/A (12), S-8 (12), CORRESP (10), 10-K (8), DEF 14A (8), DRS/A (7), SCHEDULE 13G (7), 424B5 (6), DEFA14A (6), EFFECT (6), 3/A (5), DRSLTR (5), ARS (4), SC 13D (4), SC 13D/A (4), 10-K/A (3), S-3 (3), 424B4 (2), DRS (2), F-1 (2), F-1MEF (2), 20-F (1), 8-A12B (1), CERTNAS (1), CT ORDER (1), D (1), F-1/A (1), F-3 (1), PRE 14A (1), S-3/A (1), S-3ASR (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Mar 2, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Aug 20, 2026

Securities registered for trading

ClassSymbolExchange
Ordinary Shares, par value NIS 0.01 per shareURGNNasdaq

From the cover page of the 10-K filed Mar 2, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks UroGen Pharma Ltd. names in Item 1A of its 10-K filed Mar 2, 2026: 73 risks under these headings, as written.3

  • Risks Related to Our Financial Condition and Capital Requirements
  • We have incurred significant losses and negative cash flows since our inception, and we anticipate that we will continue to incur losses and negative cash flows as we execute on our strategy and may not generate positive or sufficient cash flows from operations in the future, which may have an adverse impact on our working capital, total assets, stockholders’ equity and our ability to service our indebtedness and commitments.
  • We may require additional financing to fund our operations and achieve our goals, and a failure to obtain this capital when needed and on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development, commercialization efforts or other operations.
  • Our indebtedness resulting from our loan agreement with Pharmakon could adversely affect our financial condition or restrict our future operations.
  • Covenants under our Prepaid Forward Contract with RTW restrict our ability to borrow additional capital.
  • Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Risks Related to Our Business and Strategy
  • We are highly dependent on the successful commercialization of our approved products, Jelmyto and Zusduri.
  • Post-approval results for our approved drugs in larger numbers of patients and broader populations may not be consistent with the results from our clinical studies.
  • We have limited experience as an organization in marketing and distributing products and are therefore subject to certain risks in relation to the commercialization of Jelmyto, Zusduri and any of our product candidates that receive regulatory approval.
  • If we are unable to effectively train and equip our sales force, our ability to successfully commercialize Jelmyto, Zusduri and any future product candidates will be harmed.
  • The market opportunities for Jelmyto, Zusduri and our product candidates may be smaller than we anticipate or limited to those patients who are ineligible for established therapies or for whom prior therapies have failed and may be small.
The other 63 risks
  • Jelmyto, Zusduri and any of our product candidates that receive regulatory approval may fail to achieve the broad degree of physician adoption and use and market acceptance necessary for commercial success.
  • Jelmyto, Zusduri and our product candidates, if approved, will face significant competition with competing technologies and our failure to compete effectively may prevent us from achieving significant market penetration.
  • Our ability to market Jelmyto, Zusduri and any of our product candidates that receive regulatory approval is and will be limited to certain indications. If we want to expand the indications for which we may market our products, we will need to obtain additional regulatory approvals, which may not be granted.
  • If we are found to have improperly promoted off-label uses of Jelmyto, Zusduri or any of our product candidates that receive regulatory approval, or if physicians misuse our products, we may become subject to prohibitions on the sale or marketing of our products, significant sanctions, and product liability claims, and our image and reputation within the industry and marketplace could be harmed.
  • We are dependent on the success of Jelmyto, Zusduri and our product candidates, including obtaining regulatory approval to market our product candidates in the United States.
  • Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • We have limited experience in conducting clinical trials and obtaining approval for product candidates and may be unable to do so successfully.
  • We have not yet submitted NDAs for certain product candidates in our pipeline, and we may be delayed in obtaining, or fail to obtain, such regulatory approvals and to commercialize our product candidates.
  • Disruptions to the operations of the FDA, the SEC and other government agencies, including as a result of changes in funding or personnel, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.
  • We may not be able to advance our nonclinical product candidates into clinical development and through regulatory approval and commercialization.
  • Clinical drug development involves a lengthy and expensive process with an uncertain outcome, results of earlier studies and trials may not be predictive of future trial results, and our clinical trials may fail to adequately demonstrate the safety and efficacy of our product candidates.
  • Jelmyto, Zusduri or any of our product candidates may produce undesirable side effects that we may not have detected in our previous nonclinical studies and clinical trials or that are not expected with mitomycin treatment or inconsistent with catheter administration procedures. This could prevent us from gaining marketing approval or market acceptance for these product candidates, or from maintaining such approval and acceptance, and could substantially increase commercialization costs and even force us to cease operations.
  • We may face future developmental and regulatory difficulties related to Jelmyto, Zusduri and any of our product candidates that receive marketing approval. In addition, we are subject to government regulations and we may experience delays in obtaining required regulatory approvals to market our proposed product candidates.
  • If we are not successful in developing, receiving regulatory approval for and commercializing our nonclinical and clinical product candidates, our ability to expand our business and achieve our strategic objectives could be impaired.
  • We have entered into collaboration and licensing agreements and in the future may enter into collaboration and licensing arrangements with other third parties for the development and commercialization of our products and product candidates. If our collaboration and licensing arrangements are not successful, we may not be able to capitalize on the market potential of these products and product candidates.
  • International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
  • Failure to obtain marketing approval in international jurisdictions would prevent our approved products, Jelmyto and Zusduri, and our product candidates from being marketed abroad.
  • We rely on third parties and consultants to assist us in conducting our clinical trials for our product candidates. If these third parties or consultants do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for or commercialize our product candidates.
  • If in the future we acquire or in-license technologies or product candidates, we may incur various costs, may have integration difficulties and may experience other risks that could harm our business and results of operations.
  • We will need to continue to increase the size of our organization. If we fail to manage our growth effectively, our business could be disrupted.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of any of our products and product candidates, if approved.
  • If we fail to attract and keep senior management and key personnel, we may be unable to successfully develop our product candidates, conduct our clinical trials and commercialize any of the products we develop.
  • Under applicable employment laws, we may not be able to enforce covenants not to compete.
  • Our employees, independent contractors, clinical investigators, CROs, consultants and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
  • Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
  • Exchange rate fluctuations between the U.S. dollar and the New Israeli Shekel may negatively affect our earnings.
  • Our business could be adversely affected by the effects of health pandemics, epidemics or other public health emergencies.
  • Certain of our clinical trials and other significant operations (including our Israeli corporate offices and contract manufacturers) are located outside of the United States and, therefore, our results may be adversely affected by geopolitical, economic and military instability.
  • Our business activities may be subject to the FCPA and similar anti-bribery and anti-corruption laws of other countries in which we operate, as well as U.S. and certain foreign export controls, trade sanctions, and import laws and regulations. Compliance with these legal requirements could limit our ability to compete in foreign markets and subject us to liability if we violate them.
  • Risks Related to Our Intellectual Property
  • If our efforts to obtain, protect or enforce our patents and other intellectual property rights related to Jelmyto, Zusduri, and our product candidates and technologies are not adequate, we may not be able to compete effectively, and we otherwise may be harmed.
  • We may be subject to claims that we infringe, misappropriate or otherwise violate the intellectual property rights of third parties.
  • We may receive only limited protection, or no protection, from our issued patents and patent applications.
  • Our trade secrets may not have sufficient intellectual property protection.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may not be able to protect our intellectual property rights throughout the world.
  • If we are unable to protect our trademarks from infringement, our business prospects may be harmed.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property rights or the patents of our licensors, which could be expensive and time consuming.
  • We may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result in litigation and adversely affect our business.
  • Third-party claims alleging intellectual property infringement may adversely affect our business.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • Risks Related to Government Regulation
  • If the FDA concludes that the requirements for our relevant product candidates are not as we expect, the approval pathway for these product candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.
  • We expect current and future legislation affecting the healthcare industry, including healthcare reform, to impact our business generally and to increase limitations on reimbursement, rebates and other payments, which could adversely affect third-party coverage of our products, our operations, and/or how much or under what circumstances healthcare providers will prescribe or administer our products, if approved.
  • We may be unable to obtain Orphan Drug Designation or exclusivity for future product candidates we may develop. If our competitors are able to obtain orphan drug exclusivity for their products that are for the same indication as our product candidates, we may not be able to have competing products approved by the applicable regulatory authority for a significant period of time.
  • Orphan Drug Designation may not ensure that we will enjoy market exclusivity in a particular market, and if we fail to obtain or maintain orphan drug exclusivity for our product candidates, we may be subject to earlier competition and our potential revenue will be reduced.
  • Jelmyto, Zusduri and any of our product candidates that receive regulatory approval will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expenses, limit or withdraw regulatory approval and subject us to penalties if we fail to comply with applicable regulatory requirements.
  • Our relationships with healthcare professionals, independent contractors, clinical investigators, CROs, consultants and vendors in connection with our current and future business activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, government price reporting, and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face significant penalties.
  • Legislative or regulatory healthcare reforms in the United States or abroad may make it more difficult and costly for us to obtain regulatory clearance or approval of our product candidates or any future product candidates and to produce, market, and distribute our products after clearance or approval is obtained.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could negatively impact our business.
  • It may be difficult for us to profitably sell our products and product candidates that receive regulatory approval if coverage and reimbursement for these products is limited by government authorities and/or third-party payor policies.
  • Risks Related to Ownership of Our Ordinary Shares
  • The market price of our ordinary shares has been and may continue to be subject to fluctuation and you could lose all or part of your investment.
  • Future sales of our ordinary shares could reduce the market price of our ordinary shares.
  • Future equity offerings could result in future dilution and could cause the price of our ordinary shares to decline.
  • We have never paid cash dividends on our share capital, and we do not anticipate paying any cash dividends in the foreseeable future.
  • If we are classified as a passive foreign investment company ("PFIC"), our U.S. shareholders may suffer adverse tax consequences.
  • Changes to tax laws could have a material adverse effect on us and reduce net returns to our shareholders.
  • Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits.
  • Our ability to use our U.S. net operating loss carryforwards and certain other tax attributes to offset future taxable income and taxes may be limited.
  • Risks Related to our Operations in Israel
  • Our research and development and other significant operations are located in Israel and, therefore, our results may be adversely affected by political, economic and military conditions in Israel.
  • Provisions of Israeli law and our articles of association may delay, prevent or otherwise impede a merger with, or an acquisition of, us, even when the terms of such a transaction are favorable to us and our shareholders.
  • It may be difficult to enforce a judgment of a U.S. court against us and our officers and directors in Israel or the United States, to assert U.S. securities laws claims in Israel or to serve process on our officers and directors.
  • Your rights and responsibilities as a shareholder will be governed by Israeli law, which differs in some material respects from the rights and responsibilities of shareholders of U.S. companies.
  • Risks Related to Our Management and Employees
  • We depend on our executive officers and key clinical, technical and commercial personnel to operate our business effectively, and we must attract and retain highly skilled employees in order to succeed.

Legal proceedings

On April 2, 2024, the Company filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9,040,074 and 9,950,069 and seeking a permanent injunction preventing U.S. market entry of Teva’s generic product prior to the expiry of such patents. By written stipulation dated June 11, 2024, Teva Pharmaceutical Industries, Ltd. was dismissed from the action. On May 19, 2025 the Company filed an Amended Complaint, adding U.S. Patent 12,268,745 to the litigation (the “745 Patent”). The U.S. Patent and Trademark Office issued the ‘745 Patent on April 8, 2025, and the Company subsequently added this patent to the Orange Book for JELMYTO. By orders dated February 27, 2025, and June 26, 2025, the court approved the parties’ joint stipulations to remove the Markman hearing and any related claim-construction proceedings from the court’s calendar. This matter is scheduled for a bench trial in October 2026. Following certain stipulations, the case is now styled as UroGen Pharma Ltd. et al. v. Teva Pharmaceuticals, Inc. et al. By order dated January 12, 2026, the court approved the parties’ joint stipulation to dismiss counts I, II, III, and IV of the Company’s Amended Complaint alleging infringement by Teva of U.S. Patent Numbers 9,040,074 and 9,950,069, with prejudice, and to dismiss counts I and II of Teva’s counterclaims seeking declaratory judgment that U.S. Patent Numbers 9,040,074 and 9,950,069 are invalid, as moot. No ANDA may be finally approved by the FDA until the expiration of Orphan Drug Exclusivity covering JELMYTO in April 2027. If the Company is unsuccessful in securing the requested court relief, JELMYTO may be subject to immediate competition from an FDA approved generic product after regulatory exclusivity for JELMYTO expires in April 2027.

The opening of Item 3, Legal Proceedings.3

Sources

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