Business
UroGen Pharma Ahead of Schedule to Complete UGN-102 NDA Submission and Reports 2024 Second Quarter Financial Results and Business Highlights
Potential for an FDA decision as early as the first quarter of 2025, assuming priority review UGN-102 Phase 3 ENVISION trial demonstrated an unprecedented
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n\nPotential for an FDA decision as early as the first quarter of 2025, assuming priority review\n\n\n\nUGN-102 Phase 3 ENVISION trial demonstrated an unprecedented 82.3% Duration of Response at 12 Months by Kaplan-Meier analysis in LG-IR-NMIBC patients who achieved a complete response at three months\n\n\n\nEnded Q2 2024 with $241.3 million in cash, cash equivalents and marketable securities \n\n\n\nReported JELMYTO® Q2 2024 net product revenues of $21.8 million\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 second quarter ended June 30, 2024, and provided an overview of recent developments.\n\n\n“Our immediate priority is completing the submission of a New Drug Application in the very near term for UGN-102, which we believe has the potential to be a practice-changing therapy for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer,” said Liz Barrett, President and Chief Executive Officer of UroGen. “The compelling body of clinical data, including the ENVISION trial, which demonstrated an unprecedented 82.3% 12-month duration of response by Kaplan-Meier analysis in patients who had previously achieved a complete response at three months, reinforces the opportunity for UGN-102 to be the first FDA-approved medicine for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer.”\n\n\nMs. Barrett continued, “We estimate that approximately 82,000 patients suffering from this highly recurrent disease each year may benefit from an innovative treatment, creating an estimated five-billion-dollar market opportunity. Our immediate commercial focus is preparing for UGN-102’s potential approval and launch with the goal to establish our leadership in urothelial cancers.”\n\n\nQ2 2024 and Recent Business Highlights:\n\n\nUGN-102 (mitomycin) for intravesical solution:\n\n\n\nIn June 2024, UroGen reported positive 12-month duration of response (DOR) data from the Phase 3 ENVISION pivotal trial evaluating UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG...