CMS approved a permanent Healthcare Common Procedure Coding System Level II J‑code (J9282) for UroGen Pharma’s intravesical therapy ZUSDURI, effective January 1 2026. The company announced the approval on January 5 2026, replacing the temporary miscellaneous code that had caused a 45‑ to 60‑day lag between patient enrollment and drug administration.
The new J‑code eliminates the administrative delay that historically slowed adoption of ZUSDURI in community urology practices. By providing a clear billing pathway, providers can now secure reimbursement more quickly, improving patient access to the non‑surgical treatment for low‑grade intermediate‑risk non‑muscle invasive bladder cancer (LG‑IR‑NMIBC).
The approval is a key milestone in UroGen’s strategy to transition from a rare‑disease focus to a broader RTGel platform. With the reimbursement barrier removed, the company expects accelerated market penetration and increased sales volume for ZUSDURI, which already generated $1.8 million in net product revenue in Q3 2025 and is projected to reach $4.5 million in preliminary demand revenue for October 2025.
UroGen’s Q3 2025 results showed total net product revenue of $27.5 million, with ZUSDURI contributing $1.8 million and JELMYTO generating $25.7 million. The company serves an estimated 82,000 patients with NMIBC in the United States each year, of whom about 59,000 experience recurrence. The J‑code approval is expected to unlock a larger share of this market by removing a critical reimbursement hurdle.
CEO Liz Barrett said the permanent J‑code is “an important operational milestone that simplifies reimbursement for providers and ensures patients can access ZUSDURI without unnecessary administrative delays.” She added that the approval supports UroGen’s broader platform strategy and strengthens its competitive position in the bladder cancer space.
With the J‑code in place, UroGen is positioned to capture a larger portion of the NMIBC market, accelerate sales growth for ZUSDURI, and reinforce its transition toward a broader therapeutic platform. The regulatory milestone underscores the company’s progress in expanding access to its RTGel‑based therapies and signals a positive trajectory for future revenue generation.
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