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 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.
UroGen Pharma (Nasdaq: URGN) will present at the Piper Sandler 37th Annual Healthcare Conference taking place December 2-4, 2025. The company is scheduled for a fireside chat on December 2, 2025 at 1:00 PM ET in New York, NY.
Investors can watch a live webcast and access a replay on UroGen’s Investor Relations website; the replay will be available for approximately 90 days.
UroGen (Nasdaq: URGN) reported Q3 2025 results as its newly launched ZUSDURI gains early commercial traction and development milestones advance.
Key points: ZUSDURI net product revenue of $1.8M in Q3 with an October preliminary demand estimate of $4.5M; JELMYTO net product revenue of $25.7M in Q3 (+~13% underlying YoY demand growth); cash and marketable securities of $127.4M as of Sept 30, 2025; three-month complete response rate for UGN-103 of 77.8% (95% CI 68.3%–85.5%); FDA agreed to an NDA submission plan for UGN-103 and UGN-103 NDA anticipated in H2 2026 with potential approval in 2027; ZUSDURI assigned permanent J-code J9282 effective Jan 1, 2026.
UroGen (Nasdaq: URGN) reported a 77.8% three-month complete response (CR) rate (95% CI, 68.3%–85.5%) from the ongoing Phase 3 UTOPIA trial of UGN-103 in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
The result is consistent with a 79.6% three-month CR observed with ZUSDURI in ENVISION. The FDA agreed that CR and durability results from UTOPIA can support a New Drug Application (NDA) for UGN-103, and the company plans to prepare an NDA submission in 2026. UroGen also holds two U.S. patents covering UGN-103 that expire in December 2041.
UroGen Pharma (Nasdaq: URGN) will present at the Guggenheim Securities Healthcare Innovation Conference in Boston on November 11, 2025 at 10:30 AM ET. The company plans a presentation plus one-on-one investor meetings during the November 10–12, 2025 conference. Webcast and replay access will be available on UroGen’s investor relations website, with the replay online for approximately 90 days. The presentation focuses on recent corporate developments and investor engagement opportunities.
UroGen Pharma (Nasdaq: URGN) will report third quarter 2025 financial results on Thursday, November 6, 2025 prior to market open. A live audio webcast and conference call will follow at 10:00 AM Eastern Time. Investors can access the live webcast and a replay on UroGen’s Investor Relations website; the replay will be available for approximately 30 days. The announcement covers the timing and access details for the Q3 2025 earnings release and related investor call.
UroGen (Nasdaq: URGN) announced that the Centers for Medicare and Medicaid Services assigned a permanent HCPCS Level II J Code J9282 for ZUSDURI (mitomycin) for intravesical solution, effective January 1, 2026.
The code applies to billing in hospital outpatient departments and physician offices and is intended to standardize claims submission, simplify reimbursement processes for providers (subject to individual payor coverage policies), and reduce administrative barriers to patient access for the FDA‑approved treatment for recurrent low‑grade intermediate‑risk non‑muscle invasive bladder cancer.
UroGen Pharma (Nasdaq: URGN) announced the publication of a comprehensive clinical review of ZUSDURI™ (mitomycin) in Reviews in Urology™. ZUSDURI is the first FDA-approved non-surgical treatment for adults with recurrent, low-grade, intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC).
The clinical trials demonstrated impressive results with complete response rates between 64.8% and 79.6% at three months. Notably, 80.6% of patients remained disease-free at 18 months following complete response in the ENVISION trial, while the OPTIMA II study showed a median duration of response of 42.1 months in long-term follow-up.
The treatment showed a manageable safety profile with primarily mild to moderate adverse reactions, and importantly, did not negatively impact patients' quality of life.
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