Welcome to our dedicated page for Urogen Pharma SEC filings (Ticker: URGN), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
UroGen Pharma Ltd.'s SEC filings document operating results, product revenue disclosures, financing agreements and governance matters for a biotechnology company focused on urothelial and specialty cancers. Recent 8-K reports furnish quarterly and annual financial results tied to JELMYTO and ZUSDURI, commercial launch updates, research and development expenses, reimbursement matters and pipeline disclosures involving UGN-103 and UGN-501.
Other filings describe material definitive agreements, including term-loan refinancing and credit arrangements with BioPharma Credit entities, as well as capital-structure information for ordinary shares listed on Nasdaq. Definitive proxy statements cover board matters, executive compensation, equity awards, pay-versus-performance tables and shareholder voting matters.
UroGen Pharma reported that it has entered a settlement and license agreement with Teva Pharmaceuticals resolving patent litigation over Jelmyto, its mitomycin-based treatment for upper tract urothelial cancer. Teva had filed an Abbreviated New Drug Application seeking to market a generic Jelmyto before UroGen’s patents expired.
Under the agreement, UroGen will grant Teva a non-exclusive license to sell a generic version of Jelmyto in the United States starting on September 15, 2030, if it receives U.S. Food and Drug Administration approval and subject to certain customary conditions. All related patent cases in the U.S. District Court for the District of Delaware will be terminated, and the agreement will be reviewed by the U.S. Federal Trade Commission and the U.S. Department of Justice.
UroGen Pharma director James A. Robinson Jr. exercised restricted stock units into ordinary shares, increasing his direct share ownership. He acquired 2,000 ordinary shares through an RSU conversion and now directly holds 6,000 ordinary shares, with 2,000 RSUs remaining outstanding as a separate derivative holding.
UroGen Pharma Ltd. reports passive beneficial ownership disclosures by Paradigm BioCapital entities and Senai Asefaw as of 03/31/2026. The filing lists specific share holdings, including 1,703,949 shares reported for Paradigm BioCapital Advisors and related parties and 1,501,473 shares for Paradigm BioCapital International Fund Ltd.
The filing states these holdings represent 3.5% and 3.1% of the class respectively, calculated from 48,708,280 Ordinary Shares outstanding as of 03/31/2026 per the issuer's Form 10-Q. Reporting persons disclaim ownership beyond the shares directly held.
UroGen Pharma Ltd. holdings disclosure: The Toronto-Dominion Bank and TD Securities Inc. report beneficial ownership of 2,618,020 shares of UroGen ordinary shares, representing 5.4% of the class. The filing states TD Bank holds sole voting and dispositive power over 2,616,714 shares and TDSI holds sole voting and dispositive power over 1,306 shares. The statement is a joint Schedule 13G filing and includes a signed joint filing agreement dated May 15, 2026.
UroGen Pharma Ltd. Chief Medical Officer Mark Schoenberg sold 10,000 Ordinary Shares in an open-market transaction. The shares were sold at a weighted average price of about $30.00 per share, with individual prices ranging from $30.00 to $30.05. After this sale, Schoenberg directly holds 134,985 Ordinary Shares. The transaction was executed pursuant to a pre-arranged trading plan adopted under Rule 10b5-1(c) on 08-15-2025, indicating it was scheduled in advance rather than timed discretionarily.
UroGen Pharma Ltd. reported first-quarter 2026 revenue of $50.9 million, significantly higher than the same period in 2025, driven by sales of Jelmyto and the newly approved bladder cancer drug Zusduri. Jelmyto contributed $21.7 million and Zusduri $29.2 million in product sales.
The company posted a net loss of $23.6 million, narrower than the prior-year period, as higher gross profit was partly offset by increased selling, general and administrative spending to support commercialization. Cash, cash equivalents and marketable securities totaled $140.3 million as of March 31, 2026, while long-term debt rose to $189.5 million after closing a new $200 million term loan with Pharmakon that refinanced existing borrowings and added liquidity.
UroGen also carries a prepaid forward obligation of $128.2 million tied to future Jelmyto and Zusduri net sales. Despite an accumulated deficit of $983.3 million, management believes current cash and investments can fund operations beyond one year, assuming continued uptake of its approved products.
UroGen Pharma reported strong first quarter 2026 results driven by the launch of ZUSDURI and growth in JELMYTO. Revenue rose to $50.9 million from $20.3 million a year earlier, a 152% year-over-year increase, as ZUSDURI sales more than doubled quarter-over-quarter.
Net loss narrowed to $23.6 million, or ($0.47) per share, compared with a net loss of $43.8 million, or ($0.92) per share, in the prior-year quarter. Cash, cash equivalents and marketable securities were $140.3 million as of March 31, 2026, up from $120.5 million at year-end 2025.
The company reaffirmed 2026 JELMYTO net product revenue guidance of $97–$101 million and expects full-year 2026 operating expenses of $240–$250 million, including $20–$24 million of non-cash share-based compensation. Management highlighted accelerating ZUSDURI adoption, advancing pipeline programs UGN-103, UGN-104 and UGN-501, and an expanded debt facility with Pharmakon Advisors.
UroGen Pharma Ltd. is soliciting proxies for its 2026 Annual Meeting of Shareholders, to be held virtually on June 22, 2026 at 10:00 a.m. Eastern Time. Shareholders of record as of April 29, 2026, when 48,721,701 ordinary shares were outstanding, may attend online, ask questions and vote.
Key items include electing seven directors, approving amended Articles of Association to align shareholder proposal rights with Israeli Companies Law, and approving a Compensation Policy amendment clarifying director and officer insurance, exculpation and indemnification terms.
Shareholders are also asked to approve an amendment to the 2017 Equity Incentive Plan to add 1,000,000 ordinary shares for employee and director equity awards, give advisory approval of named executive officer compensation, and approve PricewaterhouseCoopers LLP as independent auditor until the 2027 annual meeting. The proxy explains voting methods, broker non-votes, quorum and required majorities, including special voting rules for Proposal 3.