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Urogen Pharma SEC Filings

URGN NASDAQ

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.

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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.

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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.

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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.

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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.

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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.

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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.

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BlackRock, Inc. reports beneficial ownership of UROGEN PHARMA LTD common stock totaling 2,519,771 shares as of 03/31/2026. The filing shows BlackRock holds 5.2% of the class with 2,461,477 shares of sole voting power and sole dispositive power over 2,519,771 shares.

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UroGen Pharma Ltd. is soliciting shareholder votes at its virtual 2026 Annual Meeting on June 22, 2026. The Board asks shareholders to elect seven directors, approve amended Articles of Association, approve a Compensation Policy amendment, authorize a 1,000,000-share increase to the 2017 Equity Incentive Plan, approve executive compensation (advisory) and ratify PwC as auditor.

The Board recommends FOR each proposal; the Company intends to register the additional 1,000,000 shares under Form S-8 if shareholders approve the plan increase.

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UroGen Pharma Ltd. files its annual report describing a focused uro-oncology business built around its RTGel reverse-thermal hydrogel drug-delivery platform. The company develops therapies that keep chemotherapy and immunotherapy in the urinary tract longer, aiming to improve tumor control with minimally invasive treatments.

UroGen’s approved products are Jelmyto for low-grade upper tract urothelial carcinoma and Zusduri for recurrent low-grade intermediate-risk non–muscle invasive bladder cancer, both RTGel-based mitomycin formulations designed for chemoablation instead of repeated surgery. The report details broad payer coverage, dedicated commercial infrastructure, and ongoing registries and follow-up studies to characterize long-term outcomes.

The pipeline includes next-generation mitomycin products UGN‑103 and UGN‑104 under a medac collaboration, and UGN‑501, an oncolytic virus acquired from IconOVir to target high‑grade disease and potentially other cancers. UroGen emphasizes its intellectual property estate, regulatory pathways (including 505(b)(2), orphan exclusivity and Orange Book listings), and experience navigating FDA approval, fast-track and breakthrough processes.

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Rhea-AI Summary

UroGen Pharma Ltd. files its annual report describing a focused uro-oncology business built around its RTGel reverse-thermal hydrogel drug-delivery platform. The company develops therapies that keep chemotherapy and immunotherapy in the urinary tract longer, aiming to improve tumor control with minimally invasive treatments.

UroGen’s approved products are Jelmyto for low-grade upper tract urothelial carcinoma and Zusduri for recurrent low-grade intermediate-risk non–muscle invasive bladder cancer, both RTGel-based mitomycin formulations designed for chemoablation instead of repeated surgery. The report details broad payer coverage, dedicated commercial infrastructure, and ongoing registries and follow-up studies to characterize long-term outcomes.

The pipeline includes next-generation mitomycin products UGN‑103 and UGN‑104 under a medac collaboration, and UGN‑501, an oncolytic virus acquired from IconOVir to target high‑grade disease and potentially other cancers. UroGen emphasizes its intellectual property estate, regulatory pathways (including 505(b)(2), orphan exclusivity and Orange Book listings), and experience navigating FDA approval, fast-track and breakthrough processes.

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FAQ

How many Urogen Pharma (URGN) SEC filings are available on StockTitan?

StockTitan tracks 51 SEC filings for Urogen Pharma (URGN), including 10-K annual reports, 10-Q quarterly reports, 8-K current reports, and Form 4 insider trading disclosures. Each filing includes AI-generated summaries, impact scoring, and sentiment analysis.

When was the most recent SEC filing for Urogen Pharma (URGN)?

The most recent SEC filing for Urogen Pharma (URGN) was filed on May 15, 2026.