Business
UroGen Pharma Reports Record JELMYTO Quarterly Sales and Recent Corporate Developments
Both ENVISION and ATLAS Phase 3 trials of UGN-102 met primary endpoints in treating low-grade intermediate-risk non‐muscle‐invasive bladder cancer
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n\nBoth ENVISION and ATLAS Phase 3 trials of UGN-102 met primary endpoints in treating low-grade intermediate-risk non‐muscle‐invasive bladder cancer (LG-IR-NMIBC).\n\n\n\n\nReported record JELMYTO® net product revenues in Q2 2023 of $21.1 million, an increase of ~27% from the same period last year\n\n\n\n\nSignificantly strengthened balance sheet via $120 million private placement of ordinary shares and pre-funded warrants\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, 2023, and provided an overview of recent developments.\n\n\n“We are in a transformative period for UroGen,” said Liz Barrett, President and Chief Executive Officer of UroGen Pharma. “Recently, we announced positive topline results from the ATLAS and ENVISION Phase 3 clinical trials of UGN-102 in LG-IR-NMIBC. Both trials met their primary endpoints, demonstrating consistent, compelling results for UGN-102. If approved, we believe UGN-102’s promising efficacy and safety profile across multiple trials support a potential shift from frequent surgeries to a minimally invasive, non-surgical option for the more than 82,000 underserved LG-IR-NMIBC patients diagnosed annually in the U.S. alone, positioning it as a potential key growth driver for UroGen.”\n\n\n“Furthermore, increased adoption and expansion of JELMYTO use in a diverse LG-UTUC population, supported by a growing database of real-world outcomes data, translated to notable revenue growth during the second quarter of 2023,” continued Ms. Barrett. “Building on these achievements, the recently announced $120 million private placement of ordinary shares and pre-funded warrants with a select group of biotech investors provides us with the resources to support our business, including our prospective pre-commercialization and launch strategy for UGN-102.”\n\n\nBusiness Highlights:\n\n\nUGN-102 (mitomycin) for intravesical solution:\n\n\n\nThe ENVISION Phase 3 clinical trial met its primary endpoint by demonstrating a 79.2% rate of complete response among ~240 LG-IR-NMIBC patients at 3-months after the first UGN-102 instillation.\n\n\n\n\nAdditional data evaluating the secondary endpoint of...