Every 8-K that Urogen Pharma (URGN) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow URGN and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full URGN filings page.
UroGen Pharma Ltd. (URGN) reported that its wholly owned subsidiary, UroGen Pharma, Inc., entered into an Option and Research License Agreement with IntraGel Therapeutics, Ltd. on August 18, 2026. UroGen obtained an exclusive option to secure an exclusive, worldwide license to IntraGel’s TumoCure product formulated with IntraGel’s proprietary SRGel platform for treating advanced head and neck cancer, options for additional SRGel-based products designated by UroGen, and a non-exclusive license to research and evaluate the SRGel platform.
In a related transaction, UroGen Pharma Ltd. agreed, under a Securities Purchase Agreement with IntraGel, to invest up to $7,000,000 in IntraGel’s equity securities, aligning its financial commitment with the collaboration’s development and evaluation activities.
UroGen Pharma reported strong second-quarter 2026 results, highlighted by the commercial launch of ZUSDURI. Total revenue was $72.5 million, up from $24.2 million a year earlier, including $50.4 million of ZUSDURI revenue. JELMYTO continued to contribute as a marketed product.
Operating performance improved markedly: gross profit reached $65.9 million and operating income turned slightly positive at $0.1 million, while net loss narrowed to $14.4 million, or $0.28 per share, from $49.9 million. Cash, cash equivalents and marketable securities totaled $108.0 million as of June 30, 2026.
The company reiterated 2026 JELMYTO net product revenue guidance of $97–$101 million and raised full-year 2026 operating expense guidance to $260–$270 million, including $20–$24 million of non-cash share-based compensation, reflecting accelerated investment behind ZUSDURI and pipeline candidates UGN-103 and UGN-501. A new U.S. patent allowance is expected to extend IP coverage for ZUSDURI and UGN-103 into July 2044.
UroGen Pharma Ltd. reported results of its 2026 Annual Meeting of Shareholders. Investors approved amended and restated Articles of Association that, among other changes, tie eligibility for shareholder proposals to requirements under Israeli Companies Law.
Shareholders also approved a Compensation Policy Amendment related to directors’ and officers’ insurance and an amendment to the 2017 Equity Incentive Plan to increase ordinary shares authorized for issuance under the plan by 1,000,000 shares. All seven director nominees were elected, executive pay received advisory approval, and PricewaterhouseCoopers LLP was ratified as independent auditor until the 2027 annual meeting.
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 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 reported full-year 2025 revenue of $109.8 million, up from $90.4 million in 2024, driven by the FDA approval and commercial launch of bladder cancer drug ZUSDURI and growth of kidney cancer therapy JELMYTO.
Research and development expenses rose to $67.1 million and selling, general and administrative costs increased to $155.1 million, reflecting clinical programs and launch investments. The company posted a net loss of $153.5 million, or $3.19 per share, and ended 2025 with $120.5 million in cash, cash equivalents and marketable securities.
Management highlighted 2026 as a pivotal year for the ZUSDURI rollout, with early signs of increasing physician adoption following permanent J‑Code reimbursement. UroGen guided 2026 JELMYTO net product sales to $97–$101 million and expects operating expenses of $240–$250 million while advancing late‑stage candidates UGN‑103 and UGN‑104 toward planned regulatory milestones.
UroGen Pharma Ltd. entered into a new secured term loan agreement providing up to $250,000,000 in borrowings through two tranches. A $200,000,000 Tranche A loan was funded immediately, with Tranche B of $50,000,000 available at the borrower’s election through June 30, 2027, subject to conditions.
The Tranche A proceeds refinance an existing $125,000,000 term loan and support general corporate and working capital needs; Tranche B would also fund general corporate purposes. The debt carries a fixed 8.25% annual interest rate, quarterly payments, and matures five years after the Tranche A closing date, with principal amortization beginning in the first quarter of 2030.
The facility is guaranteed by UroGen Pharma Ltd., is secured by substantially all tangible and intangible assets (including intellectual property), and includes customary affirmative and restrictive covenants but no financial covenants. Prepayments trigger a 1% exit fee and, if made within one year of each tranche’s closing, a makewhole equal to foregone interest, and a change of control requires repayment.
UroGen Pharma (URGN) reported that it announced financial results for the quarter ended September 30, 2025. The details are provided in a press release furnished as Exhibit 99.1.
The information was furnished under Item 2.02 and is not deemed “filed” under Section 18 of the Exchange Act or incorporated by reference unless specifically stated. UroGen’s ordinary shares trade on Nasdaq under the symbol URGN.
UroGen Pharma Ltd. reported the results of its 2025 annual shareholder meeting. Shareholders approved an Amended and Restated Non-Employee Director and Officer Compensation Policy and an amendment to the 2017 Equity Incentive Plan that, among other changes, increases the number of ordinary shares authorized for issuance under the plan by 2,750,000 shares.
All seven director nominees were elected. Shareholders gave advisory approval to the compensation of named executive officers and chose an annual schedule for future advisory votes on executive pay, which the board adopted until at least the 2031 annual meeting. Shareholders also approved the engagement of PricewaterhouseCoopers LLP as independent auditor until the 2026 annual meeting.