Business
UroGen Pharma Reports First Quarter 2020 Financial Results and Recent Corporate Developments
Received U.S. FDA Approval for 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 for Jelmyto™, the First and Only Non-Surgical Treatment for Patients with Low-Grade Upper Tract Urothelial Cancer (LG-UTUC)\n\n\nJelmyto Launch on Track for June 1, 2020 \n\n\nReported UGN-102 Phase 2b Trial Interim Data with 65% Complete Response at Three Months and 85% Durability at Nine Months in Low-Grade Non-Muscle Invasive Bladder Cancer \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 first quarter ended March 31, 2020 and provided an overview of the Company’s recent developments.\n\n\n“The first quarter of 2020 was marked by flawless execution by our team as we prepared for the landmark FDA approval of Jelmyto, the first and only non-surgical treatment for patients with low-grade upper tract urothelial cancer. It has been our mission to pioneer novel treatments for patients in areas of unmet need, and our team has developed innovative solutions to engage key stakeholders so we can bring this effective, kidney-sparing therapy to patients who have been waiting for new treatment options,” said Liz Barrett, President and Chief Executive Officer of UroGen. “Our momentum continues as we advance our portfolio of product candidates, highlighted by our recent UGN-102 data readout for the treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer, a disease associated with high rates of recurrence and the need for repetitive surgical intervention. The recently published positive interim UGN-102 data, combined with pivotal data for Jelmyto, further supports our confidence in the broad potential of our pipeline. We remain on track to initiate a pivotal Phase 3 study later 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\nUroGen announced the U.S. FDA granted approval of Jelmyto for the treatment of patients with LG-UTUC on April 15, 2020. Jelmyto is the first and only FDA approved non-surgical treatment option for patients with LG-UTUC.\n\n\...