Welcome to our dedicated page for Urogen Pharma news (Ticker: URGN), a resource for investors and traders seeking the latest updates and insights on Urogen Pharma stock.
UroGen Pharma Ltd. (URGN) is a biotechnology company whose news flow centers on therapies for urothelial and specialty cancers. Company announcements highlight the development and commercialization of RTGel®-based mitomycin formulations and other oncology candidates designed for non-surgical tumor ablation in the urinary tract.
On this page, readers can follow news about Jelmyto for low-grade upper tract urothelial cancer and ZUSDURI™ (mitomycin) for intravesical solution, described by UroGen as the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Updates often cover regulatory milestones such as U.S. Food and Drug Administration approvals, the assignment of a permanent HCPCS Level II J Code (J9282) for ZUSDURI, and coverage or reimbursement developments that affect access to treatment.
UroGen’s disclosures also include clinical trial results and pipeline progress, including data from the Phase 3 UTOPIA trial of UGN-103 for recurrent LG-IR-NMIBC, the clinical development program for ZUSDURI across studies such as OPTIMA II, ATLAS, and ENVISION, and ongoing work on next-generation candidates UGN-104 and UGN-501. Investors and healthcare professionals can track conference presentations, financial result releases, and corporate updates, such as inducement equity grants and proxy-related matters.
By reviewing the URGN news feed on Stock Titan, users can monitor how UroGen’s RTGel platform, approved products, and late-stage pipeline evolve over time, and how regulatory, clinical, and commercial developments may influence the company’s oncology portfolio.
UroGen (Nasdaq: URGN) reported Q1 2026 results: $51.0M total revenue and $29.2M in ZUSDURI sales. ZUSDURI grew 109% quarter-over-quarter; JELMYTO generated $21.7M (+7% YoY). Net loss narrowed to $23.6M and cash totaled $140.3M.
The company expects an NDA submission for UGN-103 in H2 2026, UGN-501 IND submission in Q2 2026, and reiterated 2026 JELMYTO guidance of $97M–$101M.
UroGen Pharma (Nasdaq: URGN) will report first quarter 2026 financial results on Wednesday, May 6, 2026, prior to the market open. A live audio webcast and conference call will follow at 10:00 AM Eastern Time.
According to the company, the public webcast is accessible via its Investor Relations website and a replay will be available on the site for approximately 30 days.
UroGen (Nasdaq: URGN) launched the LG-UTUC Luminaries initiative on April 8, 2026 to recognize clinicians and institutions showing leadership in low-grade upper tract urothelial cancer care.
The program highlights guideline-aligned, kidney-sparing approaches and names Dr. Saum Ghodoussipour as the inaugural honoree.
UroGen (Nasdaq: URGN) announced publication in The Journal of Urology of Phase 3 ENVISION results for ZUSDURI (mitomycin) for recurrent low‑grade intermediate‑risk non‑muscle invasive bladder cancer.
Key data: 24‑month event‑free probability 72.2% after three‑month complete response (CR rate 79.6%; 95% CI: 64%, 79%), median follow‑up 23.7 months, median duration of response not reached. Safety: common adverse reactions ≥10% and serious adverse reactions in 12% (urinary retention 0.8%, urethral stenosis 0.4%). ZUSDURI is the first FDA‑approved therapy for recurrent LG‑IR‑NMIBC.
UroGen (NASDAQ:URGN) applauded BCAN's New Faces of Bladder Cancer report, a national survey of more than 1,100 patients highlighting recurrence burden and procedural load.
Key findings: nearly 80% fear recurrence (over 90% for patients under 50), women 86%, retained-bladder patients 87%, many report five or more cystoscopies and some report more than 15 procedures.
UroGen (Nasdaq: URGN) announced inducement restricted stock unit grants to 11 new employees on March 6, 2026. Up to 51,200 ordinary shares may be issued upon vesting. RSUs vest equally over three years (one-third annually) and are governed by UroGen's 2019 Inducement Plan.
The grants were made as inducements pursuant to Nasdaq Listing Rule 5635(c)(4) to support commercialization of JELMYTO and ZUSDUR and continued pipeline development.
UroGen (Nasdaq: URGN) reported full-year 2025 revenue of $109.8M, driven by ZUSDURI launch and JELMYTO sales, and announced the permanent J Code (J9282) effective Jan 1, 2026 to support reimbursement.
The company closed an amended loan with Pharmakon providing a $200M initial tranche and an optional $50M tranche, reported 2025 net loss of $153.5M, and held $120.5M in cash and securities at year-end.
UroGen (Nasdaq: URGN) entered an amended senior secured term loan with funds managed by Pharmakon on Feb 26, 2026, providing up to $250 million in two tranches.
The first tranche of $200 million funded at closing refinances an existing $125 million facility, sets a fixed 8.25% interest rate, allows a discretionary $50 million draw through June 30, 2027, has no financial covenants, and schedules repayment in four equal quarterly payments beginning Q1 2030.
UroGen (Nasdaq: URGN) reported post‑hoc ENVISION Phase 3 analyses showing ZUSDURI (75 mg mitomycin intravesical) produced high complete response (CR) rates across EORTC recurrence score groups in recurrent LG‑IR‑NMIBC.
Three‑month CRs were 83.9%, 81.2%, and 60.0% for EORTC scores 1–4, 5–9, and 10–17; majority of responders remained recurrence‑free at 24 months (Kaplan‑Meier estimates 67.4%–73.7%).
UroGen Pharma (Nasdaq: URGN) will present at the TD Cowen 46th Annual Health Care Conference on March 3, 2026 at 1:50 PM ET in Boston, MA. The presentation includes a formal talk and 1x1 investor meetings.
Webcast access is available on the company website under Events & Presentations, with a replay available for about 30 days.