spawns UroGen Pharma ( NASDAQ: URGN ) announced Thursday that its Phase 3 ENVISION trial for bladder cancer therapy UGN-102 (mitomycin), which had previously reached the primary endpoint, indicated a nearly 82% duration of response at 12 months. After a brief trading halt, URGN shares climbed ~50% in reaction. The finding, based on a statistical measure known as the Kaplan-Meier estimate, represented patients who achieved complete remission three months after starting the therapy.
Additional data for 15 and 18 months suggest approximately 80% duration of response based on the same metric. ENVISION is a single-arm global trial designed to evaluate UGN-102 in patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). There were no new safety signals, and urinary tract infection and fatigue were among the most commonly cited treatment-emergent adverse events.
The company is currently submitting its marketing application for UGN-102 to the FDA on a rolling basis. It intends to complete the submission in Q3 2024 and expects a potential approval in Q1 2025. More on UroGen Pharma UroGen Pharma Ltd.
(URGN) Q1 2024 Earnings Call Transcript UroGen: All Eyes On UGN-102 Urogen files patent suit against Teva over cancer therapy Seeking Alpha’s Quant Rating on UroGen Pharma Historical earnings data for UroGen Pharma.
