Business
UroGen Pharma Reports Second Quarter 2020 Financial Results and Recent Corporate Developments
Received U.S. FDA Approval of Jelmyto®, the First and Only Non-Surgical Treatment for Patients with Low-Grade Upper Tract Urothelial Cancer (LG-UTUC)
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\nReceived U.S. FDA Approval of Jelmyto®, the First and Only Non-Surgical Treatment for Patients with Low-Grade Upper Tract Urothelial Cancer (LG-UTUC)\n\n\nSuccessfully Commenced Launch of Jelmyto on June 1st as Planned; Initial Commercial Performance Demonstrates Strong Execution\n\n\nAnnounced Positive Complete Response and Durability Data of UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC); On Track to Commence Pivotal Phase 3 Trial by Year End\n\n\nConference Call and Webcast to be Held Today at 8:30 AM ET\n\n PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced financial results for the second quarter ended June 30, 2020 and provided an overview of the Company’s recent developments.\n\n\n“The second quarter of 2020 has proved to be the most transformational time for UroGen, marked by the U.S. Food and Drug Administration approval of Jelmyto for patients with low-grade upper tract urothelial cancer and our successful transition to a commercial-stage company. Despite global challenges and uncertainty as a result of the ongoing COVID-19 pandemic, the innovative solutions developed by our team have led to strong launch execution; a testament to our commitment to advancing this important medicine for patients in need of better options,” said Liz Barrett, President and Chief Executive Officer of UroGen. “In addition to continuing our commercialization efforts of Jelmyto, we are on track to start our planned Phase 3 pivotal study of UGN-102 in patients with low-grade intermediate risk non-muscle invasive bladder cancer by the end of this year.”\n\n\nRecent Highlights and Upcoming Milestones\n\n\nJelmyto (mitomycin) for pyelocalyceal solution, formerly known as UGN-101, for adult patients with low-grade upper tract urothelial cancer (LG-UTUC)\n\n\n\nOn April 15, 2020, the U.S. FDA granted approval of Jelmyto for the treatment of adult patients with LG-UTUC. Jelmyto is the first and only FDA approved non-surgical treatment option for patients with LG-UTUC.\n\n\nUroGen successfully commenced the commercial launch of Jelmyto on June 1, 2020.\n\n\nThe commercial team continues to utilize innovative solutions, such...