Business
UroGen Pharma Meets Revenue Goal, Reports First Quarter 2023 Financial Results and Recent Corporate Developments
Reported JELMYTO® Q1 2023 net product revenues of $17.2 million, an increase of ~27% from Q1 2022 Complete Response data from ENVISION pivotal trial and
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n\nReported JELMYTO® Q1 2023 net product revenues of $17.2 million, an increase of ~27% from Q1 2022\n\n\n\nComplete Response data from ENVISION pivotal trial and topline data readout from ATLAS trial on track for summer 2023\n\n\n\n PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the first quarter ended March 31, 2023, and provided an overview of recent developments.\n\n\n“2023 is off to a promising start as we reported double-digit year-over-year growth in worldwide JELMYTO net sales during the first quarter,” said Liz Barrett, President, and Chief Executive Officer of UroGen. “JELMYTO adoption continues to grow, attributable to the growing body of evidence supporting its benefits in a real-world setting, combined with key initiatives that have expanded access and improved logistical efficiencies for physicians and patients. As we look ahead to summer 2023, we have several key events to prepare for, primarily topline results from both the ENVISION and ATLAS clinical trials investigating the potential of UGN-102 for the treatment of LG-IR-NMIBC. With prospective favorable results, we will look to submit a New Drug Application (NDA) for UGN-102 in 2024 to the U.S. Food & Drug Administration (FDA), for which we are already actively preparing.”\n\n\nBusiness Highlights:\n\n\nUGN-102 (mitomycin) for intravesical solution:\n\n\n\nA topline data readout of the primary endpoint from the ENVISION Phase 3 pivotal study of UGN-102 evaluating the complete response (CR) rate of ~240 patients at 3-months after first instillation is expected this summer.\n\n\n\nTopline data from the ATLAS clinical trial, the predecessor to ENVISION, is expected summer 2023 and will evaluate complete response, duration of response and safety from ~280 patients that completed the trial.\n\n\n\nAnnounced preliminary results of a study to assess the feasibility of home instillation of UGN-102. In this study, UGN-102 was suitable to administer at home by a visiting nurse under the supervision of a treating physician and resulted in 75% (n=8) of patients achieving a complete response, defined as no detectable disease 3 months after starting treatment.\n\n\n\nJELMYTO (mitomycin)...