Business
UroGen Pharma Reports Third Quarter 2022 Financial Results and Recent Corporate Developments
Full enrollment of ENVISION Phase 3 pivotal trial with UGN-102 in low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) expected as
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n\nFull enrollment of ENVISION Phase 3 pivotal trial with UGN-102 in low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) expected as soon as the end of November 2022; NDA submission anticipated in first half of 2024\n\n\nReported JELMYTO® net product revenue of $16.1 million, an increase of 41% from the same period last year\n\n\nFDA authorized extension of the in-use period for JELMYTO® admixture from 8 to 96 hours following reconstitution further simplifying workflow for urologists\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 third quarter ended September 30, 2022, and provided an overview of recent developments.\n\n“From a consistent vision to pipeline advancement and product commercialization, we remain highly encouraged by the inroads we have made creating a new market in how urologic cancers are treated. Despite slightly lower revenue compared to the previous quarter, JELMYTO’s favorable growth trends, which include a substantial increase of year-over-year net product revenues, new site activations, and recent real-world outcomes data, continues to give us confidence in the LG-UTUC opportunity as we work to replicate the success we’ve had in certain key markets,” said Liz Barrett, President and Chief Executive Officer of UroGen. “We anticipate that the FDA authorization this quarter to extend JELMYTO’s in-use period for the admixture from 8 hours to 96 hours following reconstitution will provide yet another significant opportunity towards driving market adoption and expansion.”\n\n“In parallel, we are rapidly advancing perhaps the most exciting investigational product in our pipeline, UGN-102, which has the potential to transform the treatment of bladder cancer and significantly broaden the utilization of our RTGel™ reverse-thermal hydrogel technology,” continued Ms. Barrett. “ENVISION, our Phase 3 pivotal trial of UGN-102 in LG-IR-NMIBC, is on pace to complete enrollment as soon as the end of the month, bringing us one step closer to realizing UGN-102’s potential as the first non-surgical primary therapeutic to treat this important subset of bladder cancer patients. As we advance each of these prog...