Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
URGN Catalyst Timeline
Dated clinical, regulatory and corporate events for UroGen Pharma Ltd.
Catalyst Timeline
Dated clinical, regulatory & corporate events for UroGen Pharma Ltd.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How URGN actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-06-30 | UGN-501 | IND Submission | IND |
Drug Pipeline Intelligence
| Product | Revenue | Prior period | Change |
|---|---|---|---|
| Zusduri | $95M | - | - |
| Jelmyto | $93M | $94M | -1% |
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| UGN-104 Small moleculeNCT06774131 | Upper Urinary Tract Urothelial Carcinoma | Phase 3 | RECRUITING | 70 | Mar 1, 2028 |
Clinical Trial Results
Readouts, endpoints and source filings for every URGN program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| ZUSDURI | recurrent low-grade intermediate-risk non-muscle invasive bladder cancer | Phase 3 | 2026-05-13 | 64.5%; 95% CI, 54.6% - 72.8%; 79.6%; 35.5 monthsRead More | ZUSDURI Median Duration of Response Still Not Reached with 64.5% 36-month Duration of Response in the Pivotal ENVISION TrialRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Schoenberg MarkOfficer (Chief Medical Officer) | Sell | -871 59,882 held | $42.92 | 09/08/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in URGN
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| RTW INVESTMENTS, LP | 1.4 % (75 %) | 167.22 M | 4.54 M |
URGN Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-11-20 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How URGN ranks across every disease it competes in
URGN News
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
UroGen Pharma has announced the grant of inducement restricted stock units (RSUs) to 19 new employees as part of their employment. This initiative aims to bolster the commercialization efforts for their approved products, JELMYTO and ZUSDURI. The RSUs will vest over three years, contingent on the employees' continued service. UroGen continues to focus on developing innovative cancer treatments.
Read more →UroGen Pharma to Present at Upcoming Investor Conferences
UroGen Pharma Ltd. has announced its participation in several upcoming investor conferences in September, including the Wells Fargo 21st Annual Healthcare Conference and the Cantor Global Healthcare Conference 2026. The company focuses on developing innovative solutions for urothelial and specialty cancers. UroGen's proprietary technology aims to improve treatment options for patients.
Read more →IntraGel Therapeutics and UroGen Pharma Sign Strategic Collaboration and Investment Agreements to Advance Sustained-Released Investigational Oncology Therapies
IntraGel Therapeutics has entered into a strategic collaboration with UroGen Pharma, which includes a $7 million equity investment to support the Phase 2 clinical study of TumoCure for advanced head and neck cancer. UroGen will gain access to IntraGel's SRGel platform, which has broad potential across various solid tumors. This partnership aims to accelerate the development of TumoCure and other oncology products.
Read more →UroGen Announces Strategic Collaboration and Investment Agreements with IntraGel to Access Biodegradable Sustained-Release Gel Platform and Expand Oncology Pipeline
UroGen has entered a strategic collaboration with IntraGel, granting it a research license and exclusive options to develop up to three oncology products using IntraGel's SRGel platform. The agreement also includes an option to acquire worldwide rights to TumoCure, an investigational therapy for advanced head and neck cancer. This partnership is expected to bolster UroGen's oncology pipeline significantly.
Read more →UroGen Submits NDA for UGN-103, an Investigational Treatment of Recurrent LG-IR-NMIBC
UroGen Pharma has announced the submission of a New Drug Application (NDA) for UGN-103, an investigational treatment aimed at recurrent LG-IR-NMIBC. This submission is a crucial milestone for the company as it seeks to advance its innovative cancer treatment solutions. The NDA submission reflects UroGen's commitment to addressing unmet medical needs in urothelial cancers.
Read more →UroGen Reports $50.4 Million of ZUSDURI Revenue and Provides Second Quarter 2026 Financial Results and Highlights
UroGen reported a revenue of $50.4 million for ZUSDURI in Q2 2026, marking a significant 73% growth compared to the previous quarter. The company anticipates a new U.S. patent that will protect ZUSDURI and UGN-103 until July 2044. Additionally, UGN-103 is progressing towards its NDA submission.
Read more →UroGen Pharma to Report Second Quarter 2026 Financial Results on Wednesday, August 5th, 2026
UroGen Pharma Ltd. will announce its second quarter 2026 financial results on August 5, 2026, before the stock market opens. A live audio webcast will follow the announcement at 10:00 AM ET, with a replay available for 30 days. The company focuses on innovative solutions for urothelial and specialty cancers.
Read more →UroGen Receives New U.S. Patent Allowance Expected to Provide Protection into July 2044 for ZUSDURI™ and UGN-103
UroGen Pharma Ltd. has announced the receipt of a Notice of Allowance for a new U.S. patent. This patent is expected to provide protection for its products ZUSDURI™ and UGN-103 until July 2044. The new patent is anticipated to strengthen UroGen's market position in the treatment of urothelial and specialty cancers.
Read more →UroGen Announces FDA Clearance of the IND for UGN-501, an Investigational Next-Generation Oncolytic Virus for Non-Muscle Invasive Bladder Cancer
UroGen has received FDA clearance for the IND of UGN-501, an investigational oncolytic virus aimed at treating non-muscle invasive bladder cancer. This approval allows the company to initiate a Phase 1 clinical study, with patient enrollment anticipated to start in Q4 2026. UGN-501 is designed to directly target tumor cells.
Read more →UroGen Announces Agreement Resolving Patent Litigation Relating to JELMYTO® (mitomycin) for pyelocalyceal solution
UroGen Pharma has entered into a settlement agreement with Teva Pharmaceuticals, resolving patent litigation regarding the generic version of JELMYTO. Under the agreement, Teva will be allowed to sell its generic version starting September 15, 2030, pending FDA approval. This resolution highlights UroGen's strong intellectual property portfolio and its commitment to advancing treatments for urothelial cancers.
Read more →UroGen Pharma to Present at the Goldman Sachs 47th Annual Global Healthcare Conference
UroGen Pharma Ltd. will present at the Goldman Sachs 47th Annual Global Healthcare Conference from June 8-10, 2026. The presentation will be available via webcast on the company's website. UroGen specializes in treatments for urothelial and specialty cancers, utilizing its proprietary RTGel technology for sustained drug release.
Read more →UroGen Reports 94.5% Six-Month Duration of Response in Phase 3 UTOPIA Trial, Advancing UGN-103 Toward Potential Approval in Recurrent Low-Grade Intermediate-Risk NMIBC
UroGen Pharma has reported promising results from its Phase 3 UTOPIA trial, showing a 94.5% durability of response for UGN-103 in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The data aligns closely with the outcomes from the pivotal ENVISION trial of ZUSDURI, which is significant for the FDA approval pathway. UroGen plans to submit a New Drug Application for UGN-103 by Q3 2026, highlighting its potential to become a new standard of care in uro-oncology. The innovative treatment aims to enhance patient outcomes through improved delivery methods.
Read more →ZUSDURI Median Duration of Response Still Not Reached with 64.5% 36-month Duration of Response in the Pivotal ENVISION Trial
UroGen Pharma announced promising results from the Phase 3 ENVISION trial of ZUSDURI for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The trial showed a 64.5% probability of remaining disease-free at three years for patients achieving a complete response at three months. Notably, these durable outcomes were achieved without the need for maintenance therapy, highlighting ZUSDURI's potential to transform treatment approaches.
Read more →UroGen Reports ZUSDURI™ Revenue More Than Doubled Quarter-over-Quarter and Provides First Quarter 2026 Financial Results and Highlights
UroGen Pharma reported significant financial growth in Q1 2026, with ZUSDURI generating $29.2 million in revenue, a 109% increase from the previous quarter. The company also highlighted advancements in its pipeline, including plans for an NDA submission for UGN-103 later this year. Despite the positive revenue growth, UroGen recorded a net loss of $23.6 million during the quarter.
Read more →UroGen Pharma to Report First Quarter 2026 Financial Results on Wednesday, May 6th, 2026
UroGen Pharma Ltd. announced it will report its financial results for the first quarter of 2026 on May 6th, 2026, before the stock market opens. A subsequent audio webcast and conference call will take place at 10:00 AM Eastern Time. Investors will have access to a live stream and a replay for approximately 30 days. This event underscores UroGen's ongoing activities in the biotech sector.
Read more →UroGen Launches LG-UTUC Luminaries Initiative Recognizing Excellence and Leadership in Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer
UroGen Pharma Ltd. has launched the "LG-UTUC Luminaries" initiative to honor clinicians and institutions making significant impacts in the treatment of low-grade upper tract urothelial cancer (LG-UTUC). This initiative aims to advance kidney-sparing care and improve patient outcomes by recognizing excellence in clinical practice. The first honoree is Dr. Saum Ghodoussipour from Rutgers Cancer Institute, acknowledged for his leadership in LG-UTUC care. The initiative emphasizes collaboration and ongoing education in the urology community to further support those affected by this rare cancer.
Read more →Journal of Urology Publishes ENVISION Trial Results Showing 72.2% 24-Month Duration of Response with ZUSDURI
UroGen Pharma announced the publication of the Phase 3 ENVISION trial results for ZUSDURI, showing a 72.2% probability of remaining event-free at 24 months after achieving a complete response. The trial results, published in The Journal of Urology, highlight ZUSDURI's potential to significantly improve the management of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The treatment offers a non-surgical option for patients, marking a significant advancement in bladder cancer therapy.
Read more →UroGen Applauds BCAN’s New Faces of Bladder Cancer Report Highlighting Recurrence Burden and Fear of Recurrence
UroGen Pharma Ltd. praised the Bladder Cancer Advocacy Network (BCAN) for its New Faces of Bladder Cancer Report, which highlights the fears and procedural burdens faced by bladder cancer patients. The report reveals that nearly 80% of respondents experience fear of recurrence, with numbers rising significantly in younger patients. It also documents the high number of cystoscopies patients endure, emphasizing the chronic nature of bladder cancer. UroGen's support for the research reflects its commitment to improving care through patient-centric data.
Read more →