UroGen reported approximately $1.8 million in ZUSDURI revenue for Q3 and $4.5 million in October, driven by a permanent J-code effective January 1 that has yielded 100% reimbursement and reduced administrative denials. Management noted an acceleration in physician uptake since the code’s implementation, buoyed by streamlined buy-and-bill processes and early positive feedback on treatment access.

Clinical data highlight an ~80% complete response rate at 12 months and 72% durability at two years following a six-week chemoablative ZUSDURI course. The company targets a prevalent U.S. population of roughly 60,000 recurrent low-grade intermediate-risk NMIBC patients, projecting a $100,000 net price and 20% penetration to drive over $1.2 billion in peak sales.

ZUSDURI is administered as a six-week intravesical gel procedure, with a typical 45–60 day interval from patient identification to treatment initiation due to pharmacy logistics and buy-and-bill setup. Early adoption is strongest among patients with multiple recurrences, rapid relapse patterns and elderly or comorbid individuals seeking to avoid repeated TURBT surgeries.