UroGen Pharma (NASDAQ: URGN) has announced that the Centers for Medicare and Medicaid Services (CMS) has assigned a permanent J Code (J9282) for ZUSDURI, its mitomycin-based intravesical solution, effective January 1, 2026. ZUSDURI is the first and only FDA-approved treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The new J Code is expected to simplify billing and reimbursement processes, facilitating broader patient access through hospital outpatient departments and physician offices.
This milestone represents a critical step in the commercial rollout of ZUSDURI. By standardizing billing and reducing administrative burdens, the J Code enables healthcare providers to prescribe and deliver the therapy more efficiently. The streamlined reimbursement process also minimizes delays and uncertainty for patients, many of whom face repeated tumor recurrences and surgical interventions like Transurethral Resection of Bladder Tumor (TURBT). Given that bladder cancer predominantly affects older patients with significant comorbidities, ZUSDURI’s non-surgical, catheter-delivered treatment offers a meaningful advancement in care.
ZUSDURI utilizes UroGen’s proprietary RTGel hydrogel technology, a sustained-release formulation that allows mitomycin to remain in contact with bladder tissue for extended periods. This targeted, localized therapy enables tumor ablation without the need for surgical resection. RTGel has already been validated in UroGen’s upper tract urothelial cancer program, and its application to recurrent LG-IR-NMIBC provides a much-needed alternative in a disease where up to 70% of patients experience recurrence.
Upcoming Catalysts:
The permanent J Code is expected to drive the commercial expansion of ZUSDURI starting in early 2026, providing reimbursement clarity that will likely accelerate adoption across U.S. oncology and urology practices. Investors will closely monitor UroGen’s upcoming financial disclosures to assess the early revenue trajectory of ZUSDURI. Additionally, updates on the company’s RTGel platform pipeline, which has the potential to address other urothelial and specialty cancers, will be key areas of focus.
Valuation:
UroGen’s valuation model incorporates multiple indications, including JELMYTO and ZUSDURI (UGN-102) & UGN-103. Probability of success (PoS) factors range from 90% to 30%, depending on approval likelihood and market realization. A 30% discount rate is applied, alongside assumptions of additional capital raises in the final share count. These projections inform Free Cash Flow to the Firm (FCFF), Discounted EPS (dEPS), and Sum-of-the-Parts (SOP) models, which are equal-weighted and averaged to derive a 12-month price target of $25.
Risk Factors:
Key risks include Clinical/Regulatory Risk, Partnership and Financial Risk, Commercial Risk, Legal and Intellectual Property Risk, and Market Share Risk.
About UroGen
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urological and specialty cancers because patients deserve better options. UroGen has developed a proprietary innovative technology platform, RTGel®, a reverse-thermal sustained-release hydrogel that has the potential to improve therapeutic profiles of existing drugs. UroGen’s sustained-release technology is designed to work with the urologic anatomy—not against it—enabling longer exposure of the urinary tract tissue to medications and making local therapy a potentially more effective treatment option.
JELMYTO® (mitomycin) for pyelocalyceal solution and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade intermediate risk non-muscle invasive bladder cancer, are designed to ablate tumors by nonsurgical means. UroGen is headquartered in Princeton, NJ with operations in Israel.
For more information about UroGen please visit www.urogen.com
The post UroGen Pharma Secures Permanent J Code for ZUSDURI™ appeared first on PRISM MarketView.
