Business
UroGen Pharma Reports Highest Revenue Quarter and Significant Full Year 2022 Growth and Recent Corporate Developments
Reported JELMYTO® full year 2022 net product revenues of $64.4 million, an increase of 34% from full year 2021 Completed enrollment of the ENVISION Phase 3
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n\nReported JELMYTO® full year 2022 net product revenues of $64.4 million, an increase of 34% from full year 2021\n\n\nCompleted enrollment of the ENVISION Phase 3 pivotal clinical trial for UGN-102 for LG-IR-NMIBC\n\n\nTopline data readout from ATLAS clinical study and Complete Response from ENVISION pivotal study expected to be reported mid-year 2023\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 fourth quarter and full year ended December 31, 2022, and overview of recent developments.\n\n“I’m proud of our progress in 2022 and encouraged by our pipeline advancement and expanded access to JELMYTO as we work to fundamentally change the treatment paradigm of urologic cancers,” said Liz Barrett, President and Chief Executive Officer of UroGen. “Last year was a marked year for our exciting investigational product, UGN-102, with the potential to transform the treatment of bladder cancer as the only non-surgical therapeutic for LG-IR-NMIBC. As we have shared many times, we believe UGN-102 could be a transformational product, and one that represents a significant opportunity to address the estimated 80,000 patients suffering from LG-IR-NMIBC in the U.S. each year. In 2022, we initiated and completed enrollment of ENVISION, our Phase 3 pivotal study of UGN-102, and more recently shared long-term follow up data from the previously completed OPTIMA II study, which showed a 24.4-month median time to recurrence in evaluable patients who completed the study. Topline data from the ATLAS and ENVISION trials are expected mid-year 2023, and assuming positive results, we remain on track to submit a New Drug Application (NDA) in 2024. Supported by a growing body of real-world outcomes data, we delivered our strongest ever JELMYTO net sales in Q4 helping propel ~34% full-year growth for fiscal 2022. Looking ahead, we remain confident in the long-term success of JELMYTO in low-grade upper tract urothelial cancer (LG-UTUC) and the significant market opportunity of UGN-102, if approved, to drive growth in the years ahead.”\n\nBusiness Highlights:\n\nUGN-102 (mitomycin) for intravesical solution:\n\n\nAnnounced full enrollment in Phase 3 ENVISION pivotal...