Business
UroGen Pharma Reports Third Quarter 2021 Financial Results and Recent Corporate Developments
Shift to single-arm Phase 3 study for UGN-102 in bladder cancer streamlines pivotal study to form basis of FDA submission Jelmyto® net product revenue of
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n\nShift to single-arm Phase 3 study for UGN-102 in bladder cancer streamlines pivotal study to form basis of FDA submission\n\n\nJelmyto® net product revenue of $11.4 million for the third quarter of 2021; New patient starts in September and October outpace July and August by nearly 60%\n\n\nConference call and webcast to be held today at 10:00 AM ET\n\n\n PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, today announced financial results for the third quarter ended September 30, 2021, and provided an overview of the Company’s recent developments.\n\n“The third quarter of 2021 was one of continued progress at UroGen, both clinically and commercially,” said Liz Barrett, President and Chief Executive Officer of UroGen. “As we highlighted at our Spotlight Event last week, we will initiate a new single-arm Phase 3 study of UGN-102 in low-grade, intermediate-risk, non-muscle invasive bladder cancer. We believe this new design affords a higher probability of regulatory success for UGN-102 in patients with low-grade IR-NMIBC, while allowing us to remain on-track for a planned NDA submission in 2024.” She added, “Additionally, as we approach the close of 2021, we are pleased with the strong demand we’re seeing for Jelmyto. September and October marked our highest months ever for both new patient starts and patient enrollment forms. We look forward to a strong start to 2022, as we advance and grow our pipeline while furthering the adoption of Jelmyto with the goal of it becoming the standard of care for patients with low-grade UTUC.”\n\nBusiness Highlights:\n\nJelmyto (mitomycin) for pyelocalyceal solution:\n\n\nAchieved highest-ever Patient Enrollment Forms and New Patient Starts in September and October 2021.\n\n\nUroGen generated net product revenue of $11.4 million for the third quarter of 2021, representing over 200% growth over the third quarter of 2020 (first full quarter of launch), this compares to $13.0 million in the second quarter of 2021.\n\n\nAs of November 1, 2021, 706 sites have been activated, which means they have completed their internal processes and have treated or are ready to treat patients. This represents a 73% increase since August 1, 2021.\n\n\nSites that have...