Urogen Pharma LTD 8-K filings

UroGen Pharma announced robust second quarter 2026 financial results, highlighted by a 73% surge in ZUSDURI revenue to $50.4 million and significant progress in its drug development pipeline.

UroGen Pharma Ltd. announced a settlement and license agreement with Teva Pharmaceuticals to resolve patent litigation concerning Jelmyto, granting Teva a license for its generic version starting September 15, 2030.

UroGen Pharma reported strong Q1 2026 financial results, driven by a more than doubling of ZUSDURI revenue quarter-over-quarter, alongside steady growth for JELMYTO and pipeline advancements.

UroGen Pharma announced its Q4 and full-year 2025 financial results, highlighting the successful launch of ZUSDURI and robust JELMYTO sales.

UroGen Pharma Ltd. secured a new $250 million term loan facility, with $200 million immediately funded to refinance existing debt and support general corporate needs.

UroGen Pharma reported its Q3 2025 financial results, highlighting accelerating ZUSDURI launch momentum and solid JELMYTO revenue growth, alongside pipeline updates and a strategic discontinuation.

UroGen Pharma Ltd. shareholders approved an amended compensation policy and an increase of 2.75 million shares to its equity incentive plan at the 2025 Annual Meeting.

UroGen Pharma announced the FDA approval and commercial launch of ZUSDURI for recurrent LG-IR-NMIBC, alongside an 11% increase in JELMYTO net product sales to $24.2 million for Q2 2025, despite an increased net loss.

UroGen Pharma Ltd. announced one-time special bonuses totaling $845,000 to its top executives in recognition of their leadership leading to the U.S. Food and Drug Administration's approval of ZUSDURI for recurrent low-grade intermediate risk non-muscle invasive bladder cancer.

Urogen Pharma Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved ZUSDURI (mitomycin), formerly UGN-102, for the treatment of recurrent low-grade intermediate risk non-muscle invasive bladder cancer.

UroGen Pharma announces Q1 2025 financial results with JELMYTO sales growth and prepares for potential FDA approval and commercial launch of UGN-102 in June 2025.

UroGen Pharma reports positive 18-month duration of response data from the Phase 3 ENVISION trial for UGN-102 and announces its fourth quarter and full year 2024 financial results, including JELMYTO revenue growth.

UroGen Pharma expands its pipeline by acquiring IconOVir Bio's assets, including the ICVB-1042 product candidate, through a combination of stock issuance, milestone payments, and royalties.

UroGen Pharma is advancing UGN-102 towards potential FDA approval, targeting a paradigm shift in treating low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

UroGen Pharma reported its third quarter 2024 financial results, highlighted by the FDA acceptance of the New Drug Application for UGN-102 and a potential launch in 2025.

UroGen Pharma has announced the departure of its Chief Financial Officer, Don Kim, and the appointment of Christopher Degnan as his successor, effective October 8, 2024.

UroGen Pharma has received a $25 million loan tranche to fund general corporate and working capital needs.

Fred E. Cohen, M.D., D.Phil., has resigned from the board of directors of UroGen Pharma Ltd., effective immediately, with no indication of disagreement with the company.

UroGen Pharma has completed its submission to the U.S. Food and Drug Administration for its New Drug Application for UGN-102, targeting low-grade intermediate-risk non-muscle invasive bladder cancer.

UroGen Pharma is ahead of schedule for its UGN-102 NDA submission, reporting strong 12-month duration of response data and Q2 2024 financial results.

UroGen Pharma's shareholders approved a new compensation policy for non-employee directors and officers, and an amendment to the company's equity incentive plan at their 2024 annual meeting.

UroGen Pharma has launched a public offering to raise approximately $107.5 million through the sale of ordinary shares and pre-funded warrants.

UroGen Pharma reported positive 12-month duration of response data from its Phase 3 ENVISION trial for UGN-102, a potential treatment for low-grade intermediate risk non-muscle invasive bladder cancer.

UroGen Pharma reported first quarter 2024 financial results, highlighted positive clinical data for UGN-102 and JELMYTO, and provided updates on its pipeline.

UroGen Pharma announced strong JELMYTO revenue growth, progress on UGN-102 regulatory submission, and a restructured financing agreement.

UroGen Pharma highlighted the potential of its pipeline, including JELMYTO, UGN-102, and UGN-301, at the TD Cowen 44th Annual Health Care Conference.

UroGen Pharma has received notification that Teva Pharmaceuticals has submitted an Abbreviated New Drug Application (ANDA) seeking to market a generic version of UroGen's Jelmyto.

UroGen Pharma highlighted its progress in developing treatments for urothelial cancers, including JELMYTO, UGN-102, and UGN-301, at the Sixth Annual Guggenheim Healthcare Talks Conference.

UroGen Pharma has entered into an exclusive licensing agreement with medac for a specific mitomycin formulation and announced plans to initiate a Phase 3 trial for its next-generation bladder cancer treatment, UGN-103.