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Permanent J Code for ZUSDURI™ Now in Effect, Expanding Patient Access to Innovative Bladder Cancer Therapy

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PRINCETON, N.J., Jan. 05, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd....

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AI Summary

UroGen Pharma (URGN) has improved access to its bladder cancer therapy, ZUSDURI, through the implementation of a permanent J Code, effective January 1, 2026. This change is expected to streamline the reimbursement process, facilitating quicker patient access to treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Trading Thesis

URGN's improved reimbursement processes for ZUSDURI could lead to increased sales and market share.

Market-Moving

  • The permanent J Code for ZUSDURI may significantly enhance patient treatment access.
  • Increased availability of ZUSDURI could drive higher sales and revenue for URGN.
  • Reimbursement reforms generally boost investor confidence in biotech firms.
  • Efficient billing processes may attract more healthcare providers to use ZUSDURI.
  • Increased patient access can positively impact URGN's stock performance.

Key Facts

  • ZUSDURI is FDA-approved for low-grade intermediate-risk bladder cancer.
  • Approximately 82,000 U.S. patients diagnosed with NMIBC annually.
  • 59,000 patients suffering recurrence of NMIBC each year.
  • Permanent coding J9282 is intended for Medicare reimbursement.
  • URGN utilizes proprietary RTGel technology for delivering treatments.

Companies Mentioned

  • UroGen Pharma (URGN): URGN now benefits from streamlined billing for ZUSDURI.
  • Centers for Medicare & Medicaid Services (CMS): CMS's new coding could enhance the drug's market accessibility.
  • Bladder Cancer Advocacy Network (N/A): BCAN supports ZUSDURI’s coding change for patient access improvement.

Corporate Developments

The announcement falls under Corporate Developments as it directly relates to regulatory changes that will improve access to URGN's key product, thereby potentially increasing its market position and financial performance.

FAQ

Why Bullish?

Historically, companies experiencing favorable regulatory decisions see positive stock movement. For URGN, the J Code is anticipated to enhance revenue from ZUSDURI.

How important is it?

The article discusses a critical change that will facilitate patient access to a key product, likely increasing URGN's revenue and market share.

Why Short Term?

The positive impact on stock price is expected immediately as market reacts to improved access and expected financial performance.

Related Companies

CMSN/A

Improved Access to ZUSDURI™ Through Permanent J Code for Bladder Cancer Therapy

UroGen Pharma Ltd. (Nasdaq: URGN), a leading biotech company focused on innovative solutions for treating urothelial and specialty cancers, has announced a significant enhancement in patient access to ZUSDURI™ (mitomycin) for intravesical solution. Effective January 1, 2026, the Centers for Medicare & Medicaid Services has assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II J Code, J9282, specifically for ZUSDURI, thereby streamlining the billing and reimbursement processes for both outpatient hospital settings and physician offices.

Details of the Permanent J Code Implementation

The newly established J Code is set to alleviate administrative delays that often hinder timely treatment for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). Liz Barrett, President and CEO of UroGen, emphasized the stress caused by delays in treatment, stating, “With the permanent J Code now in effect for ZUSDURI, providers have a clearer, more efficient path to securing reimbursement, facilitating patient access without unnecessary administrative hurdles.”

  • The J Code simplifies the reimbursement process for eligible Medicare patients.
  • It is a pivotal move in enhancing reliable access to ZUSDURI, an essential therapy for bladder cancer patients.
  • Healthcare providers will benefit from a more efficient claims submission process.

The Importance of Timely Access to Treatment

ZUSDURI stands as the first and only FDA-approved treatment for adults with recurrent LG-IR-NMIBC, offering patients a vital nonsurgical chemoablative option. The significance of timely treatment could not be overstated, especially for individuals facing not only the disease but also the complexities and uncertainties of multiple procedures. Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network (BCAN), remarked on the impact of the J Code: “A permanent J Code may seem like a technical change, but for patients, it translates into more broad access to treatment.”

About ZUSDURI and Non-Muscle Invasive Bladder Cancer

ZUSDURI (mitomycin) utilizes UroGen’s proprietary RTGel® technology, delivering a sustained-release hydrogel formulation directly into the bladder, allowing for non-surgical tumor treatment. This innovation presents a compelling treatment option for the approximately 82,000 people diagnosed with NMIBC each year in the U.S., of which around 59,000 experience recurrence.

The median age of those diagnosed with bladder cancer is 73 years, highlighting the need for effective, less invasive treatment options like ZUSDURI. Research indicates that up to 70% of NMIBC patients have at least one recurrence, reinforcing the importance of timely intervention strategies.

About UroGen Pharma Ltd.

UroGen is committed to developing innovative therapies for urothelial and specialty cancers. Headquartered in Princeton, NJ, and with operations in Israel, the company has created the RTGel platform, which enhances the therapeutic profiles of existing drugs through localized sustained release. UroGen’s product pipeline includes not only ZUSDURI but also other solutions aimed at improving patient outcomes in cancer treatment.

Key Safety Information Regarding ZUSDURI

ZUSDURI is a prescription medication indicated for adults with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). Patients are advised to discuss any previous medical conditions with their healthcare provider before starting treatment. Notably, ZUSDURI should not be administered if patients have a perforated bladder or a known allergy to mitomycin.

Potential side effects may include changes in urine color, fluctuations in blood chemistry, and urinary complications. Patients should report any adverse effects to the FDA or directly to UroGen Pharma for further guidance.

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