Business
UroGen Pharma Reports Third Quarter 2020 Financial Results and Recent Corporate Developments
Top-line Results from UGN-102 OPTIMA II Phase 2b Trial Expected by Year End 2020; On Track to Initiate Phase 3 ATLAS Trial by Year End Achieved Jelmyto® Net
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\nTop-line Results from UGN-102 OPTIMA II Phase 2b Trial Expected by Year End 2020; On Track to Initiate Phase 3 ATLAS Trial by Year End \n\nAchieved Jelmyto® Net Product Revenue of $3.5 Million in First Full Quarter of Commercialization \n\nManagement Team Expanded to Drive Platform Expansion and Growth Strategies\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 third quarter ended September 30, 2020 and provided an overview of the Company’s recent developments.\n\n“We are excited to see the continued interest and uptake of Jelmyto for patients with low-grade upper tract urothelial cancer in the first full quarter of launch, with a steady increase in new patients and providers as well as positive reimbursement trends. Additionally, we are pleased with the feedback we are receiving from urologists who see this treatment as a novel solution to avoid surgical intervention with a positive impact on patient outcomes,” said Liz Barrett, President and Chief Executive Officer of UroGen. “With our second product candidate, UGN-102, soon to enter a pivotal trial and a recently enhanced management team, we look forward to continuing our mission of bringing novel solutions to patients with specialty cancers and urologic diseases.”\n\nBusiness Highlights and Upcoming Milestones:\n\nJelmyto (mitomycin) for pyelocalyceal solution:\n\n\nSince the June 1, 2020 launch of Jelmyto®, the first and only FDA approved non-surgical treatment option for adult patients with low-grade upper tract urothelial cancer (LG-UTUC), the Company has expanded prescriber usage, broadened awareness and increased coverage by commercial plans and Medicare.\n\n\nAs of November 1, 2020, 165 sites have been activated, which means they have completed their internal processes and have treated or are ready to treat patients; 13 sites have treated more than one patient.\n\n\nThe Company has received its C-Code, effective October 1, 2020, and continues to expect receipt of a J-Code in January 2021.\n\n\nFinal durability data from the Phase 3 OLYMPUS pivotal trial evaluating Jelmyto (UGN-101) in LG-UTUC is expected...