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

Rhea-AI Summary

UroGen (Nasdaq: URGN) announced that the permanent HCPCS Level II J Code J9282 for ZUSDURI (mitomycin) intravesical solution became effective January 1, 2026. The code was assigned by the Centers for Medicare & Medicaid Services and is expected to streamline billing and reimbursement in hospital outpatient and physician office settings, reducing administrative delays and improving timely patient access to ZUSDURI. ZUSDURI is described as the first and only FDA‑approved therapy for adults with recurrent low‑grade intermediate‑risk non–muscle invasive bladder cancer (LG‑IR‑NMIBC). Use of J9282 for eligible Medicare claims is available as of January 1, 2026, subject to individual payer coverage policies.

Positive

• J9282 effective January 1, 2026
• Streamlined billing for hospital outpatient and physician office settings
• Improved patient access to ZUSDURI for recurrent LG‑IR‑NMIBC

Negative

• Coverage and payment remain subject to individual payer policies
• J Code implementation does not guarantee universal reimbursement

News Market Reaction – URGN

-2.55%

15 alerts

-2.55% News Effect

-3.7% Trough in 58 min

-$27M Valuation Impact

$1.02B Market Cap

0.2x Rel. Volume

On the day this news was published, URGN declined 2.55%, reflecting a moderate negative market reaction. Argus tracked a trough of -3.7% from its starting point during tracking. Our momentum scanner triggered 15 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $27M from the company's valuation, bringing the market cap to $1.02B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Permanent J code: J9282 Effective date: January 1, 2026 HCPCS level: Level II

3 metrics

Permanent J code J9282 HCPCS Level II J Code assigned to ZUSDURI

Effective date January 1, 2026 Date J9282 became effective for billing

HCPCS level Level II Healthcare Common Procedure Coding System code category

Market Reality Check

Price: $20.92 Vol: Volume 430,130 is about 0...

low vol

$20.92 Last Close

Volume Volume 430,130 is about 0.55x the 20-day average of 787,688, indicating subdued trading interest pre‑announcement. low

Technical Price $22.71 is trading above the 200-day MA $16.30, reflecting a pre‑news uptrend despite the recent pullback.

Peers on Argus

URGN was down 3.03% while close biotech peers showed mixed moves: EYPT (-4.79%),...

URGN was down 3.03% while close biotech peers showed mixed moves: EYPT (-4.79%), SYRE (-6.65%), QURE (-2.66%) declined, SANA rose (+1.45%), and OCS was modestly lower (-1.19%). This points to stock‑specific rather than broad sector momentum.

Historical Context

5 past events · Latest: Dec 05 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 05	Equity inducement grants	Neutral	-4.8%	Inducement RSU grants to new employees supporting commercialization and pipeline work.
Nov 25	Conference appearance	Neutral	+2.8%	Piper Sandler healthcare conference fireside chat and webcast availability for investors.
Nov 06	Earnings and pipeline	Positive	+21.9%	Q3 2025 results, growing JELMYTO and ZUSDURI revenues, and UGN-103 development updates.
Nov 06	Clinical trial update	Positive	+21.9%	Phase 3 UTOPIA trial three‑month CR rate and FDA agreement on UGN-103 NDA strategy.
Nov 04	Conference presentation	Neutral	-3.9%	Guggenheim healthcare innovation conference presentation and investor meetings disclosure.

Pattern Detected

Recent history shows strong positive alignment between major clinical/earnings updates and sizeable price gains, while routine corporate or conference news has produced smaller, mixed reactions.

Recent Company History

Over the last two months, UroGen has reported several important milestones. On Nov 6, 2025, Q3 2025 results and UGN-103 progress, including ZUSDURI J-code timing, coincided with a 21.91% gain, matching a similarly strong move on the same day’s UTOPIA Phase 3 data. In contrast, conference appearances on Nov 4 and Nov 25, 2025 and inducement grants on Dec 5, 2025 led to modest, mixed price changes. Today’s J-code effectiveness update extends that prior reimbursement narrative for ZUSDURI.

Market Pulse Summary

This announcement centers on reimbursement infrastructure for ZUSDURI, with permanent J code J9282 e...

Analysis

This announcement centers on reimbursement infrastructure for ZUSDURI, with permanent J code J9282 effective January 1, 2026 under the Healthcare Common Procedure Coding System. That change is positioned to streamline billing for recurrent low‑grade intermediate‑risk non–muscle invasive bladder cancer treatment and may support broader clinical adoption. In context of earlier earnings and clinical data that highlighted ZUSDURI’s launch and UGN‑103 development, investors may watch future updates on claim utilization, payer coverage trends, and progress toward NDA timelines for related pipeline assets.

Key Terms

healthcare common procedure coding system, j code, intravesical, non–muscle invasive bladder cancer, +2 more

6 terms

healthcare common procedure coding system regulatory

"the permanent Healthcare Common Procedure Coding System Level II J Code for ZUSDURI"

A standardized set of alphanumeric codes used to identify medical services, procedures, supplies and durable equipment for billing, reporting and reimbursement in the U.S. healthcare system. Investors care because these codes determine how and whether providers and suppliers get paid, affect revenue streams, pricing and regulatory compliance, and are regularly updated—like SKUs for medical care that shape cash flow and reimbursement risk.

j code regulatory

"the permanent Healthcare Common Procedure Coding System Level II J Code for ZUSDURI"

A J-code is a standardized billing identifier used in U.S. healthcare for injectable drugs, biologics and certain complex therapies that Medicare and many insurers use to track, price and pay for treatments. Like a barcode on a store product that tells cashiers what to charge and how to stock an item, J-codes influence how quickly providers get paid, how easily patients can access a medicine, and therefore a drug maker’s revenue and market predictability.

intravesical medical

"ZUSDURI™ (mitomycin) for intravesical solution became effective on January 1, 2026"

Intravesical describes a medical treatment or procedure where a drug or therapy is placed directly into the bladder through a catheter rather than taken by mouth or injected into the bloodstream. For investors, it signals a focused delivery method that can increase local effectiveness and reduce whole‑body side effects, often affecting a product’s clinical value, patient convenience, regulatory path, and market niche — like watering a plant at its roots instead of spraying its leaves.

non–muscle invasive bladder cancer medical

"recurrent low-grade intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC)"

A form of bladder cancer that is confined to the bladder’s inner lining and has not grown into the muscle layer; think of it like weeds on the surface of a lawn rather than roots that have gone deep. It matters to investors because it typically requires frequent monitoring, repeat procedures and long-term treatments to prevent recurrence, creating steady demand for diagnostics, therapies and medical devices with different regulatory and commercial dynamics than deeper, more aggressive cancers.

chemoablative medical

"offers patients a nonsurgical chemoablative option"

Chemoablative describes a medical approach that destroys unwanted tissue—usually tumors—by applying a chemical agent directly to the affected area so cells are killed or removed rather than surgically cut out. Think of it like using a spot weed killer on a patch of lawn instead of reworking the whole yard: it aims to remove the problem locally. Investors watch chemoablative treatments because they can offer new therapeutic options, different safety profiles, and distinct regulatory and commercial pathways compared with systemic drugs or surgery.

centers for medicare & medicaid services regulatory

"The new code, J9282, assigned by the Centers for Medicare & Medicaid Services"

The Centers for Medicare & Medicaid Services (CMS) is the U.S. federal agency that runs major public health insurance programs and sets rules for what treatments and services are paid for and how much providers receive. Think of it as the rulebook and paymaster for a large portion of the health-care system: its coverage decisions, payment rates, and regulations can quickly change revenues, costs, and market access for hospitals, insurers, drugmakers and medical-device companies, so investors track its actions closely.

AI-generated analysis. Not financial advice.

PRINCETON, N.J., Jan. 05, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that adult patients living with recurrent low-grade intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC) now have improved access to an important therapy, as the permanent Healthcare Common Procedure Coding System Level II J Code for ZUSDURI™ (mitomycin) for intravesical solution became effective on January 1, 2026. The new code, J9282, assigned by the Centers for Medicare & Medicaid Services, is expected to streamline billing and reimbursement processes across hospital outpatient and physician office settings, reducing administrative delays that often stand between patients and timely treatment.

“Bladder cancer patients repeatedly share with us that delays in access to treatment, not just the disease itself, can be one of the most stressful parts of their care journey,” said Liz Barrett, President and Chief Executive Officer of UroGen. “With the permanent J Code now in effect for ZUSDURI, providers have a clearer, more efficient path to securing reimbursement, which in turn facilitates patient access to ZUSDURI without unnecessary administrative hurdles. This is a meaningful step toward more reliable, predictable access to an important therapy for those navigating this highly recurrent disease.”

For individuals facing fear, uncertainty and repeated procedures associated with recurrent low-grade intermediate-risk bladder tumors, timely access to treatment can be critical. ZUSDURI, the first and only FDA-approved therapy for adults with recurrent LG-IR-NMIBC, offers patients a nonsurgical chemoablative option.

“A permanent J Code may seem like a technical change, but for patients, it translates into more broad access to treatment,” said Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network (BCAN). “Streamlined billing helps treatment centers provide timely care, reduces financial uncertainty, and reduces administrative burden. We applaud the implementation of J9282 and the positive impact we anticipate it will have on the bladder cancer community.”

As of January 1, 2026, physicians and treatment centers can utilize J9282 for ZUSDURI when submitting claims for eligible Medicare patients, subject to individual payer coverage policies.

About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel^® technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.

About UroGen Pharma Ltd. 
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product is approved to treat low-grade upper tract urothelial cancer, and our second product, ZUSDURI (mitomycin) for intravesical solution, is approved for adult patients with recurrent LG-IR-NMIBC. Both products are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.UroGen.com to learn more or follow us on X, @UroGenPharma.

APPROVED USE FOR ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after previously receiving bladder surgery to remove tumor that did not work or is no longer working.

IMPORTANT SAFETY INFORMATION

You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI.

Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you:

• have kidney problems
• are pregnant or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI.
  
  

Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose.

Males being treated with ZUSDURI: You should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose.

• are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose.
  
  

How will I receive ZUSDURI?

• You will receive your ZUSDURI dose from your healthcare provider 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter. It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider’s instructions.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
• During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
  
  

After receiving ZUSDURI:

• ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 hours.
• To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
• Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
  
  

The most common side effects of ZUSDURI include: increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increased or decreased white blood cell counts, urinary tract infection, and blood in your urine.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Please see ZUSDURI Full Prescribing Information, including the Patient Information, for additional information.

Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the expected benefits of ZUSDURI’s permanent J Code, including its potential to streamline administrative processes across hospital outpatient and physician office settings, improve patient accessibility to ZUSDURI and deliver meaningful benefits to patients; the estimated annual U.S. patient population and demographics for LG-IR-NMIBC; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs, other than mitomycin; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. Words such as “anticipate”,” “can,” “estimate,” “expect,” “likely,” “may,” “potential,” “up to,” “will” or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: clinical results may not be indicative of results that may be observed in the future, including in larger populations; potential safety and other complications related to UroGen’s products; risks related to our and our licensors’ ability to protect our respective patents and other intellectual property; the ability to maintain regulatory approval; complications associated with commercialization activities; labeling limitations; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s products and product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies or procedures, such as surgery; UroGen’s ability to attract or retain key management, members of the board of directors and other personnel; UroGen’s RTGel technology and ZUSDURI may not perform as expected; new data relating to ZUSDURI, including from spontaneous adverse event reports and from the ongoing ENVISION trial, may result in changes to the product label and may adversely affect sales, or result in withdrawal of ZUSDURI from the market; the potential for payors to delay, limit or deny coverage for ZUSDURI; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; and the impacts of general macroeconomic and geopolitical conditions on UroGen’s business and financial position. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 6, 2025, the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.

INVESTOR CONTACT:
Vincent Perrone
Senior Director, Investor Relations
vincent.perrone@UroGen.com
609-460-3588 ext. 1093

MEDIA CONTACT:
Cindy Romano
Director, Corporate Communications
cindy.romano@UroGen.com 
609-460-3583 ext. 1083

FAQ

What is the new HCPCS J Code for ZUSDURI and when did it become effective for URGN?

The permanent HCPCS Level II J Code is J9282, effective January 1, 2026.

How does J9282 affect reimbursement for ZUSDURI (URGN)?

J9282 is expected to streamline billing and reimbursement across hospital outpatient and physician office settings, reducing administrative delays.

Does the J9282 code guarantee Medicare will pay for ZUSDURI for all patients?

No; use of J9282 for eligible Medicare claims is available, but coverage and payment remain subject to individual payer coverage policies.

Which patients are intended to benefit from J9282 for ZUSDURI (URGN)?

Adult patients with recurrent low‑grade intermediate‑risk non–muscle invasive bladder cancer (LG‑IR‑NMIBC) are the indicated population.

Can providers start using J9282 immediately for URGN ZUSDURI claims?

Yes; physicians and treatment centers can utilize J9282 for eligible Medicare claims as of January 1, 2026, subject to payer policies.