UroGen Pharma
UroGen Pharma is a commercial-stage biopharmaceutical company that develops and commercializes RTGel reverse-thermal hydrogel-based mitomycin therapies for urothelial cancers, with two FDA-approved products (JELMYTO, ZUSDURI) serving US urologists and oncology specialists treating low-grade upper tract urothelial cancer and recurrent non-muscle invasive bladder cancer.
- Company typePublic
- Founded2020
- HeadquartersNew York, United States
- Headcount251–500
- GTM typeB2B
- OfferingHardware or Manufacturing
What UroGen Pharma does
UroGen Pharma is a commercial-stage biopharmaceutical company specializing in urothelial cancers, with its corporate headquarters in Princeton, NJ and R&D operations in Ra'anana, Israel. The company is built around RTGel, a proprietary reverse-thermal hydrogel that exists as a liquid at low temperatures and transitions to a gel at body temperature, enabling sustained-release delivery of mitomycin directly into the urinary tract. This platform underpins two FDA-approved products: JELMYTO (mitomycin) for pyelocalyceal solution, approved April 2020 for low-grade upper tract urothelial cancer (LG-UTUC), and ZUSDURI (mitomycin) for intravesical solution, approved June 2025 as the first FDA-approved drug for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
UroGen commercializes its products in the United States through a direct field-based sales organization targeting urologists and oncology specialists, supported by reimbursement services (UroGen Support) and free administration supplies (Chilling Block, Uroject12, IVAK/UCAK kits). International distribution is handled through an exclusive license with Neopharm in Israel and a Named Patient Program administered by Tanner Pharma. The company has a multi-asset pipeline including UGN-102 (NDA under FDA review), UGN-103 and UGN-104 (next-generation RTGel + medac lyophilized mitomycin formulations), and UGN-501 (an oncolytic virus acquired from IconOVir Bio in February 2025 for high-grade NMIBC).
UroGen is publicly traded on NASDAQ under ticker URGN. The company has funded operations through a mix of equity (~$107.5M public offering in June 2024) and non-dilutive debt (Pharmakon Advisors: $100M in 2022, expanded to up to $250M in Q1 2026). Full-year 2025 revenue was $109.8M (+21% YoY), with Q1 2026 revenue of $51.0M (+152% YoY) reflecting the ZUSDURI launch ramp; the company remains unprofitable with a 2025 net loss of -$153.5M. ZUSDURI carries an 88.66% gross margin and management cites peak sales potential exceeding $1 billion by 2030.
UroGen Pharma firmographics
Firmographics- Name
- UroGen Pharma
- Legal name
- UroGen Pharma Ltd. and UroGen Pharma, Inc.
- Website
- https://urogen.com
- Company type
- Public
- Founded year
- 2020
- Operating status
- Operating
- Headcount range
- 251–500 employees
- Short description
- UroGen Pharma is a commercial-stage biopharmaceutical company that develops and commercializes RTGel reverse-thermal hydrogel-based mitomycin therapies for urothelial cancers, with two FDA-approved products (JELMYTO, ZUSDURI) serving US urologists and oncology specialists treating low-grade upper tract urothelial cancer and recurrent non-muscle invasive bladder cancer.
- Ownership category
- akta.pro rank
UroGen Pharma industry classification
Industry- Product category
- Urological Oncology Pharmaceuticals
- NAICS
- Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254)
- SIC
- Pharmaceutical Preparations (2834), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Nephrology & Urology Specialty Pharmaceuticals (HLAIACAH)
- akta.pro secondary industries
- Nephrology & Urology Pharmaceuticals (HLAIAAAM), Rare Oncology & Hematologic Malignancy Therapies (HLAIAIAC)
Keywords
Where UroGen Pharma is headquartered
LocationHeadquarters
- HQ city
- New York
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
UroGen Pharma business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Marketing or Sales, Personnel, Operations
Revenue model
- Product Sales - ZUSDURI: ZUSDURI (mitomycin) for intravesical solution, FDA-approved for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Generated $29.2M in Q1 2026 revenue, representing 109% quarter-over-quarter growth. Full-year 2025 net product revenue was $15.8M.
- Product Sales - JELMYTO: JELMYTO (mitomycin) for pyelocalyceal solution, FDA-approved for low-grade upper tract urothelial cancer. Achieved $94M in net product sales in 2025, up from $90.4M in 2024, with Q1 2026 revenue of $21.7M representing 7% year-over-year growth.
- International Licensing - Neopharm (Israel): Exclusive license and supply agreement with Neopharm Group to market and sell JELMYTO in Israel. JELMYTO is approved by Israeli Ministry of Health for treatment of adult patients with low-grade Upper Tract Urothelial Cancer.
- Named Patient Program - Tanner Pharma: Named Patient Program administered by Tanner Pharma Group providing controlled, pre-approval access to JELMYTO in select countries where JELMYTO is not yet available or approved, in response to unsolicited requests by physicians on behalf of specific patients.
Go-to-market motion1 record
Distribution channels3 records
Marketing channels5 records
UroGen Pharma product offering
Product offeringCore offering
UroGen Pharma develops and commercializes FDA-approved pharmaceutical therapies for urothelial and specialty urological cancers using its proprietary RTGel reverse-thermal hydrogel technology platform. The company sells two FDA-approved mitomycin-based drugs—JELMYTO for low-grade upper tract urothelial cancer (LG-UTUC) and ZUSDURI for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)—along with associated administration devices to urologists and oncology specialists.
Product overview
UroGen Pharma is a biotechnology company developing and commercializing innovative solutions for urothelial and specialty cancers. The company offers two FDA-approved products leveraging its proprietary RTGel reverse-thermal hydrogel technology: Jelmyto (approved April 2020) for low-grade upper tract urothelial cancer and Zusduri (approved June 2025) for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Both products provide non-surgical tumor ablation options. The pipeline includes UGN-102 (NDA under FDA review), UGN-103 (Phase 3 completed, NDA submission planned 2026), UGN-104 (Phase 3 enrolling), and UGN-501 (acquired oncolytic virus in IND-enabling stage). The company also provides associated medical devices and administration kits including the Chilling Block, Uroject12, and catheter administration kits.
Differentiator
Problem solved
Functional benefit
Brands
- RTGel: Proprietary reverse-thermal hydrogel technology platform that enables sustained-release drug delivery for urological treatments
- JELMYTO
- ZUSDURI
Products and services
- JELMYTO (mitomycin) for pyelocalyceal solution FDA-approved mitomycin-based therapy using RTGel reverse-thermal hydrogel technology for non-surgical tumor ablation in adult patients with low-grade upper tract urothelial cancer (LG-UTUC). First and only treatment of its kind, administered by urologists via ureteral catheter.
- ZUSDURI (mitomycin) for intravesical solution FDA-approved mitomycin-based therapy using RTGel reverse-thermal hydrogel technology for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), offering a non-surgical alternative to repeated TURBT procedures.
Quantifiable outcome
- 64.5% probability of remaining event-free at 36 months in patients achieving complete response at 3 months (79.6%)
- +4 more outcomes
Companies that use UroGen Pharma
Customer profileNamed customers1 record
Segments3 records
Ideal customer profiles1 record
UroGen Pharma technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature1 record
UroGen Pharma partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered strategic, core, regional, minor and terminated.
- IconOVir BiostrategicUroGen acquired ICVB-1042 (now known as UGN-501) from IconOVir Bio in February 2025 for $4 million. UGN-501 is a next-generation investigational oncolytic virus for high-grade non-muscle invasive bladder cancer, engineered for efficient cell entry, strong selectivity for malignant cells, and rapid replication in tumor microenvironment.
- medac GmbHcoreLicense and supply agreement for next-generation products combining RTGel technology with medac's proprietary lyophilized mitomycin formulation. Includes UGN-103 (80mg formulation for LG-IR-NMIBC) and UGN-104 (for LG-UTUC). medac patents with protection until 2035; UroGen has separate patents expiring December 2041.
- Neopharm GroupregionalExclusive license and supply agreement to market and sell Jelmyto in Israel. JELMYTO is approved by Israeli Ministry of Health for treatment of adult patients with low-grade Upper Tract Urothelial Cancer and is available in Israel. Neopharm is part of privately owned group operating in healthcare in more than 60 countries.
- Tanner Pharma GroupminorTanner Pharma Group administers Named Patient Program for Jelmyto in select countries where Jelmyto is not yet available or approved. Provides controlled, pre-approval access in response to unsolicited requests by physicians, hospitals, pharmacies, distributors, or ministries of health on behalf of specific patients.
- Agenus Inc.terminatedLicense agreement for anti-CTLA-4 drug zalifrelimab (UGN-301). UroGen terminated the agreement in November 2025 after Phase 1 data did not meet internal benchmarks for advancement. Termination effective upon expiration of 180-day notice period.
Scale indicators15 records
Recent moves6 records
Expansion highlights6 records
UroGen Pharma competitors and assessment
Company assessmentBroad incumbents
- Bristol-Myers Squibb: Markets Opdivo (nivolumab) for NMIBC indications and competes in the broader urologic oncology space. Overlaps with UroGen's NMIBC patient population as part of a diversified oncology and specialty franchise.
- AstraZeneca: Markets Imfinzi (durvalumab) and other immuno-oncology agents with relevance in bladder and urologic cancers. A broad oncology incumbent whose bladder-cancer indications intersect with UroGen's target NMIBC population.
- Merck & Co. Markets Keytruda (pembrolizumab) for BCG-unresponsive NMIBC and other urologic cancers. Competes with UroGen in the NMIBC treatment paradigm but as a broad-based oncology immuno-oncology leader rather than a urology specialist.
- Johnson & Johnson: Developing TAR-200, a gemcitabine-releasing intravesical system for NMIBC, leveraging J&J's large oncology and urology commercial footprint. Competes for the same NMIBC patients and urologist prescribing slots as UroGen, but as part of a much broader oncology/urology portfolio.
Direct peers
- ImmunityBio: Received FDA approval for Anktiva (nogapendekin alfa inbakicept-pmln) in NMIBC, a novel IL-15 superagonist intravesical therapy. Competes head-to-head in the NMIBC space, particularly in BCG-unresponsive settings where UroGen's products also compete.
- Photocure: Markets Hexvix/Cysview, a blue-light cystoscopy agent used in bladder cancer detection and management of NMIBC. Comparable because it serves the same urologist prescribers and NMIBC patient flow that UroGen's ZUSDURI and JELMYTO address.
- CG Oncology: Clinical- and commercial-stage immuno-oncology company developing cretostimogene grenadenorepvec for BCG-unresponsive NMIBC. Most directly comparable competitor in the same intravesical NMIBC treatment space, targeting overlapping urologist prescribers.
Others
- Teva Pharmaceutical Industries: Settled UroGen's JELMYTO patent litigation in June 2026 and obtained a non-exclusive license to launch a generic JELMYTO on September 15, 2030. Relevant as the future generic entrant whose entry will directly pressure UroGen's legacy UTUC franchise.
- Veracyte: Specializes in urologic cancer genomic diagnostics (e.g., Decipher Prostate, Afirma). Adjacent ecosystem participant that serves the same urologist and oncology specialist customer base and could be a strategic partner or comparable in the urologic oncology workflow.
- Pfizer (via prior Allergan Aesthetics / Ferring-derived Adstiladrin):
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks7 records
Key highlights7 records
Customer concentration
UroGen Pharma social profiles
Digital presenceUroGen Pharma financial estimates
Financial estimateRevenue estimate
Valuation estimate
UroGen Pharma leadership team
Management profileNumber of profiles
Profiles9 records
UroGen Pharma funding detail
Funding detailFunding overview
Funding rounds8 records
Investors4 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
UroGen Pharma M&A and investment
M&A and investmentM&A1 record
Investments1 record
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about UroGen Pharma
What does UroGen Pharma do?
UroGen Pharma develops and commercializes FDA-approved pharmaceutical therapies for urothelial and specialty urological cancers using its proprietary RTGel reverse-thermal hydrogel technology platform. The company sells two FDA-approved mitomycin-based drugs—JELMYTO for low-grade upper tract urothelial cancer (LG-UTUC) and ZUSDURI for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)—along with associated administration devices to urologists and oncology specialists.
Is UroGen Pharma a public or private company?
UroGen Pharma is a public company. It is classified as public and is currently operating.
When was UroGen Pharma founded?
UroGen Pharma was founded in 2020. It employs 251 to 500 people.
Where is UroGen Pharma based?
UroGen Pharma is headquartered in New York, United States, in the North America region.
How does UroGen Pharma make money?
Four revenue lines are on record. Product Sales - ZUSDURI is the primary driver. The others are product Sales - JELMYTO, international Licensing - Neopharm (Israel) and named Patient Program - Tanner Pharma.
Who are UroGen Pharma's main competitors?
Broad incumbents on record are Bristol-Myers Squibb, AstraZeneca, Merck & Co. and Johnson & Johnson. Direct peers are ImmunityBio, Photocure and CG Oncology. Others are Teva Pharmaceutical Industries, Veracyte and Pfizer (via prior Allergan Aesthetics / Ferring-derived Adstiladrin).
Does UroGen Pharma have an API?
No public API is recorded for UroGen Pharma.
What industry is UroGen Pharma in?
UroGen Pharma's product category is Urological Oncology Pharmaceuticals. Its primary akta.pro industry code is HLAIACAH, Nephrology & Urology Specialty Pharmaceuticals, with a secondary code of HLAIAAAM, Nephrology & Urology Pharmaceuticals. Its NAICS code is 325412 and its SIC code is 2834.