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UroGen Pharma Ltd.

URGN
OvervaluedBiotech · Commercial
FDA catalysts, PDUFA dates & pipeline intelligence
$36.92
▼ -0.06 · -0.16%

Financials

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52W LOW $15.8652W HIGH $50.81
Volume
35.07 K
Value Traded
29.86 M
Short % Float
15.05%
-10.68%Week
-17.82%1 Month
-4.1%3 Month
+71.44%6 Month
+53.1%5 Year
+117.55%All Time

Cash Data

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Key Stats

Market Cap
1.81 B
EPS (TTM)
-2.00
P/E Ratio
-
Ent. Value
1.90 B
Total Shares
48.88 M
Float Shares
41.51 M
Insiders
15.09%
Institutions
80.65%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
NDA Submission
UGN-103
high-grade non-muscle invasive bladder cancer
NDASmall MoleculesOncology
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PoA blends historical approval base rates, trial design score and FDA review track record.

URGN Catalyst Timeline

Dated clinical, regulatory and corporate events for UroGen Pharma Ltd.

Catalyst Timeline

Dated clinical, regulatory & corporate events for UroGen Pharma Ltd.

314Total events
11Upcoming
84Tier-1 (high impact)
2016 to 2044Coverage

Upcoming catalysts 2

T2Enrollment Complete
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UGN-104
T2Trial Initiation
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UGN-501

Event history 50

▲Partnership / LicenseCorporate
IntraGel and UroGen sign strategic collaboration and investment agreements
▼Equity OfferingCorporate
UroGen to invest up to $7 million in IntraGel equity
●NDA SubmissionUGN-103FiledRegulatory Filing
NDA submitted to FDA for UGN-103
recurrent LG-IR-NMIBCsource ↗
▲Quarterly UpdateZUSDURIApprovedCorporate
ZUSDURI Q2 2026 revenue of $50.4 million reported
▲Patent GrantedZUSDURIApprovedIP / Competition
New U.S. patent expected to provide protection into July 2044 for ZUSDURI and UGN-103
●Timing GuidanceUGN-103FiledPresentation
NDA submission for UGN-103 expected in Q3 2026
recurrent low-grade intermediate-risk non-muscle invasive bladder cancersource ↗
▲Patent GrantedZUSDURIApprovedIP / Competition
New U.S. patent expected to provide protection into July 2044 for ZUSDURI and UGN-103
▲Quarterly UpdateZUSDURIApprovedCorporate
ZUSDURI Q2 2026 revenue of $50.4 million
◆Oral PresentationPresentation
UroGen management to present at Goldman Sachs 47th Annual Global Healthcare Conference
▲IP Litigation RulingJELMYTOApprovedIP / Competition
Settlement and license agreement with Teva resolving patent litigation for JELMYTO
low-grade Upper Tract Urothelial Cancer (LG-UTUC)source ↗
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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 %
2026-06-30UGN-501 IND Submission IND
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

D38 / 100
Pipeline Score
$214M
Pipeline Value
$827M
Commercial Value
Overvalued
Valuation Signal
4
Drugs Scored
0.2x
rNPV / MCap
Top 46%
Small Cap
(rank 303 of 658)
Percentile Rank
UroGen Pharma Ltd. faces pipeline headwinds (38/100), with $455M risk-adjusted pipeline value, led by UGN-104 in Upper Urinary Tract Urothelial Carcinoma (Phase 3).
Commercial products (revenue basis: trailing 4 quarters of total revenue (10-K and 10-Q), to Jun 2026; product lines: last four quarters to Jun 2026 (10-K and 10-Q)) Revenue $188.7M x 4.4 = $827M
ProductRevenuePrior periodChange
Zusduri$95M--
Jelmyto$93M$94M-1%
Showing 1 of 4 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
UGN-104 Small moleculeNCT06774131Upper Urinary Tract Urothelial CarcinomaPhase 3 RECRUITING 70Mar 1, 2028
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Clinical Trial Results

Readouts, endpoints and source filings for every URGN program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
ZUSDURI recurrent low-grade intermediate-risk non-muscle invasive bladder cancerPhase 32026-05-1364.5%; 95% CI, 54.6% - 72.8%; 79.6%; 35.5 monthsRead MoreZUSDURI Median Duration of Response Still Not Reached with 64.5% 36-month Duration of Response in the Pivotal ENVISION TrialRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Schoenberg MarkOfficer (Chief Medical Officer)Sell -871 59,882 held$42.92 09/08/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
RTW INVESTMENTS, LP 1.4 % (75 %) 167.22 M 4.54 M
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Shares held by hedge funds each quarter, and who bought or sold.

URGN Institutional Ownership Trends

Options Data

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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-11-20
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Real-Time Option Chain

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Calls vs Puts by Expiry

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Competitive positioning

How URGN ranks across every disease it competes in

Competitive Position is a premium feature
See how URGN ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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URGN News

URGN
Sep 4, 2026
URGNGeneral

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.

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URGN
Sep 2, 2026
URGNConferences/Events

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.

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URGN
Aug 20, 2026
URGNPhases
▼ -6.9%on this news

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.

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URGN
Aug 20, 2026
URGNGeneral
▼ -6.9%on this newsshared move

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.

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URGN
Aug 17, 2026
URGNFDA Updates

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.

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URGN
Aug 5, 2026
URGNGeneral
▲ +16.3%on this news

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.

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URGN
Jul 29, 2026
URGNGeneral

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.

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URGN
Jul 15, 2026
URGNGeneral

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.

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URGN
Jul 8, 2026
URGNFDA Updates

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.

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URGN
Jun 2, 2026
URGNGeneral

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.

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URGN
Jun 1, 2026
URGNConferences/Events

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.

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URGN
May 15, 2026
URGNPhases

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.

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URGN
May 13, 2026
URGNPhases

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.

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URGN
May 6, 2026
URGNGeneral
▲ +10.2%on this news· ran to +31% by day 3shared move

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.

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URGN
Apr 29, 2026
URGNConferences/Events

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.

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URGN
Apr 8, 2026
URGNGeneral
▲ +5.9%on this news

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.

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URGN
Mar 30, 2026
URGNPhases

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.

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URGN
Mar 13, 2026
URGNGeneral

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.

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About UroGen Pharma Ltd.

Ra'Anana, L3 291 employees urogen.com
Headquarters9 HA'TA'ASIYA ST, RA'ANANA, L3, 4365007
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