Business
UroGen Pharma Delivers Double Digit JELMYTO® Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102
Initiated submission of a rolling NDA to the FDA for UGN-102; 12-month duration of response data from ENVISION expected to support completion of NDA
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n\nInitiated submission of a rolling NDA to the FDA for UGN-102; 12-month duration of response data from ENVISION expected to support completion of NDA submission\n\n\n\nAnnounced next-generation novel mitomycin-based RTGel formulations for LG-IR-NMIBC and LG-UTUC programs from medac GmbH licensing agreement with potential IP protection until December 2041\n\n\n\nJELMYTO® achieved net product revenues of $82.7 million in 2023, an increase of ~28% compared with 2022\n\n\n\nAnnounced signing of a restructured agreement with Pharmakon Advisors that provides more favorable terms and provides UroGen up to an additional $100 million credit facility\n\n\n\nConference call and webcast to be held today at 10:00 AM ET\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 fourth quarter and full year ended December 31, 2023, and provided an overview of recent developments.\n\n\n“In 2023, UroGen achieved important operational and clinical milestones, setting us up for further success in the coming years,” said Liz Barrett, President and Chief Executive Officer of UroGen. “The Phase 3 ATLAS and ENVISION trials both produced meaningful and unprecedented results underscoring the potential of UGN-102 to fundamentally change the way patients with low-grade intermediate-risk non-muscle invasive bladder cancer are treated. We look forward to reporting the 12-month duration of response data from ENVISION in the second quarter of 2024 and to completing submission of an NDA in September of this year. UGN-102 has the potential to address a more than $3 billion market opportunity and, if approved, has the potential to be transformative for our company. JELMYTO continues to show double digit growth with patient and physician adoption expected to continue to increase.”\n\n\n2023 and Recent Business Highlights:\n\n\nUGN-102 (mitomycin) for intravesical solution:\n\n\n\nIn January 2024, UroGen initiated submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for UGN-102 as a treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The first part of the submission was the Chemistry, Manufac...