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) 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.
UroGen Pharma (Nasdaq: URGN) will report fourth quarter and full-year 2025 financial results on Monday, March 2, 2026, before the market opens. A live audio webcast and conference call will follow at 10:00 AM Eastern Time.
According to the company, the live public webcast will be accessible via its investor relations website, with a replay available on the site for approximately 30 days after the call.
UroGen Pharma (Nasdaq: URGN) will present at the Guggenheim Securities Emerging Outlook: Biotech Summit on February 12, 2026 at 2:30 PM ET in New York.
Format includes a fireside chat and 1x1 investor meetings. A live webcast will be available on UroGen’s Events & Presentations page, with a replay accessible for approximately 90 days.
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.
UroGen Pharma (Nasdaq: URGN) announced on December 5, 2025 inducement grants of restricted stock units (RSUs) to 14 new employees under its 2019 Inducement Plan in connection with their employment.
Up to 32,500 ordinary shares are issuable upon vesting. The RSUs vest equally over three years (one-third each year on the anniversary of the vesting date), subject to continued service and the RSU agreement terms. Grants were made as inducements in accordance with Nasdaq Listing Rule 5635(c)(4). New hires will support commercialization of Jelmyto (mitomycin) for pyelocalyceal solution and ZUSDURI (mitomycin) for intravesical solution and UroGen’s pipeline development.