Centers for Medicare and Medicaid Services Assigns Permanent J Code for ZUSDURI™ Effective January 1, 2026

Core Insights - UroGen Pharma Ltd. has received a permanent J Code (J9282) from the Centers for Medicare and Medicaid Services (CMS) for ZUSDURI (mitomycin), the first FDA-approved treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) [1][2] - The J Code will be effective from January 1, 2026, and aims to streamline billing and claims submission for healthcare providers [1][2] - ZUSDURI utilizes UroGen's proprietary RTGel® technology, allowing for non-surgical treatment of bladder tumors through a sustained release, hydrogel-based formulation [3][5] Company Overview - UroGen Pharma is focused on developing innovative solutions for urothelial and specialty cancers, with a commitment to improving treatment options for patients [5] - The company has developed RTGel technology, which enhances the therapeutic profiles of existing drugs by enabling longer exposure of urinary tract tissue to medications [5] - UroGen's product portfolio includes ZUSDURI for recurrent LG-IR-NMIBC and a previously approved product for low-grade upper tract urothelial cancer [5] Market Context - Approximately 82,000 individuals in the U.S. are diagnosed with NMIBC annually, with around 59,000 cases being recurrent [4] - The median age of diagnosis for bladder cancer is 73 years, and up to 70% of NMIBC patients experience at least one recurrence [4]