Business
UroGen Pharma Reports Fourth Quarter and Full Year 2019 Financial Results and Recent Corporate Developments
Prescription Drug User Fee Act (PDUFA) Goal Date of April 18th for UGN-101 in Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC) Experienced
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\nPrescription Drug User Fee Act (PDUFA) Goal Date of April 18th for UGN-101 in Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC)\n\n\nExperienced Commercial Team Hired and Prepared for Planned UGN-101 Approval and Launch in Q2\n\n\nConference Call and Webcast to be held Today at 8:30 AM ET\n\n NEW YORK--(BUSINESS WIRE)--\n\nUroGen Pharma Ltd. (Nasdaq:URGN) a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, today announced financial results for the fourth quarter and full year ended December 31, 2019 and provided an overview of the Company’s recent developments.\n\n\n“At UroGen, we are eagerly awaiting potential approval of our lead product candidate, UGN-101, for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). The significant progress on key clinical, regulatory and commercial milestones in 2019 places us in a position of strength as we prepare to deliver the first non-surgical therapy for the treatment of LG UTUC. Our experienced commercial team has been working tirelessly to ensure we are prepared for launch, and we look forward to providing these patients with a new treatment option,” said Liz Barrett, President and Chief Executive Officer (CEO) of UroGen. “We are also advancing multiple pipeline candidates in development for areas of unmet need in both low-grade and high-grade bladder cancer, including UGN-102 and UGN-302, respectively. As our team pioneers new treatments to improve patient care in specialty cancers and urologic diseases, we look forward to maximizing patient and shareholder value through the exciting events on the horizon”.\n\n\n2019 and Recent Highlights \n\n\nUGN-101 (mitomycin gel) for instillation for Patients with LG UTUC Progress\n\n\n\nReported positive updated durability and complete response data from the pivotal Phase 3 OLYMPUS trial in September 2019. The data were consistent with previously reported results in May 2019 and January 2019.\n\n\nCompleted a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).\n\n\nReceived FDA filing acceptance and Priority Review of the NDA for UGN-101, with a PDUFA goal date of April 18, 2020. If approved, UGN-101 will be the first non-surgical, chemoablative treatment option for L...