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UroGen Pharma Ltd. (URGN+5.36%) has submitted its Form 10-K filing for the fiscal year ended December 31, 2024.
The filing includes details on UroGen's financial performance, highlighting a net loss of $126.9 million for the year, compared to a net loss of $102.2 million in 2023. The company reported cash and cash equivalents of $241.7 million as of December 31, 2024.
UroGen's commercial product, Jelmyto, is approved for the treatment of low-grade upper tract urothelial cancer (UTUC) and was launched in the United States in June 2020. The company is focusing on expanding Jelmyto's market presence and achieving broader adoption among healthcare providers.
The company is also advancing its lead product candidate, UGN-102, for the treatment of low-grade intermediate risk non-muscle invasive bladder cancer (NMIBC). UroGen completed the submission of a rolling NDA for UGN-102 in August 2024, and the FDA accepted the NDA in October 2024, assigning a PDUFA goal date of June 13, 2025.
UroGen continues to develop its proprietary RTGel technology, which is designed to improve the therapeutic profiles of existing drugs by enabling longer exposure of the urinary tract tissue to medications.
The company faces several risks, including the need for additional financing, potential competition, and the dependency on the successful commercialization of Jelmyto. UroGen also highlights the challenges of maintaining regulatory compliance and managing intellectual property rights.
UroGen's research and development efforts are primarily focused on urothelial and specialty cancers, with several product candidates in various stages of clinical development, including UGN-103, UGN-104, UGN-201, and UGN-301.
The filing outlines UroGen's strategy to establish Jelmyto as the standard of care for low-grade UTUC, advance UGN-102, and expand its product pipeline through both internal development and potential collaborations.
UroGen acknowledges the impact of geopolitical, economic, and military instability in Israel, where its research and development facilities are located, on its operations and financial results.
The company remains committed to addressing unmet medical needs in uro-oncology and leveraging its proprietary technology to develop innovative solutions for patients with urothelial cancers.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the UroGen Pharma Ltd. annual 10-K report dated March 10, 2025. To report an error, please email earnings@qz.com.