UroGen Pharma Overview
UroGen Pharma is a biotech company that builds novel solutions to revolutionize the way specialty cancers and urologic diseases are treated. The company has developed RTGel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen's sustained-release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen's lead product candidates, UGN-101 (mitomycin urothelial gel, known as MitoGel) and UGN-102 (mitomycin intravesical gel, known as VesiGel), are designed to potentially remove tumors by nonsurgical means and to treat several forms of non-muscle-invasive urothelial cancer, including low-grade upper-tract urothelial carcinoma and bladder cancer, respectively. In April 2020, the FDA accepted for filing UroGen's new drug application for UGN-101 (mitomycin gel) for the treatment of low-grade upper-tract urothelial cancer. UGN-101 will be the only drug available for this type of cancer.
Cumulative Funding Raised Over Time ($)
$1.5MJan 2010
$121.5MJul 2023
$196.5MMar 2021
$296.5MMar 2022
$303.5MMay 2013
$321.5MNov 2015
Latest News
growth-positive
Biogen Inc. (BIIB) Q3 Earnings and Revenues Top Estimates
Biogen Inc. reported quarterly earnings of $4.81 per share, surpassing the Zacks Consensus Estimate of $3.89 per share, marking a 23.65% earnings surprise. The company also reported revenues of $2.53 billion, exceeding the consensus estimate by 8.31%. Despite these positive results, Biogen shares have declined by about 3.3% since the start of the year, underperforming the S&P 500s gain of 17.2%. The companys earnings outlook and estimate revisions will be crucial for future stock performance. Currently, Biogen holds a Zacks Rank #3 (Hold), indicating expected market performance alignment in the near term.
growth-positive
Adherex Technologies Inc. (FENC) May Report Negative Earnings: Know the Trend Ahead of Q3 Release
Adherex Technologies Inc. (FENC) is expected to report a year-over-year increase in earnings and revenues for the quarter ending September 2025. The company is anticipated to post a quarterly loss of $0.08 per share, representing a 61.9% improvement from the previous year, with revenues expected to rise by 60.3% to $11.17 million. The consensus EPS estimate has been revised significantly lower over the past 30 days, reflecting a reassessment by analysts. The Zacks Earnings ESP model suggests that a positive earnings surprise is likely, especially if combined with a strong Zacks Rank. This could lead to a positive impact on the companys stock price.
growth-positive
UroGen Pharma to Report Third Quarter 2025 Financial Results on Thursday, November 6th, 2025
UroGen Pharma Ltd., a biotech company focused on developing treatments for urothelial and specialty cancers, announced it will report its third-quarter 2025 financial results on November 6th, 2025. The announcement will be followed by a live webcast and conference call. UroGen has developed RTGel® reverse-thermal hydrogel, a platform technology that enhances the therapeutic profiles of existing drugs. The company has two FDA-approved products for treating low-grade upper tract urothelial cancer and recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The webcast will be accessible on UroGens Investor Relations website, with a replay available for 30 days.
Public Trading
growth-negative
Urogen Pharma (URGN) Expected to Beat Earnings Estimates: Should You Buy?
Urogen Pharma (URGN) is anticipated to report a year-over-year decline in earnings despite higher revenues for the quarter ending September 2025. The company is expected to post a quarterly loss of $0.72 per share, a 30.9% decrease from the previous year, while revenues are projected to rise by 22.9% to $30.98 million. The consensus EPS estimate has been revised downwards by 5.91% over the last 30 days. The Zacks Earnings ESP model suggests that a positive Earnings ESP, combined with a strong Zacks Rank, could indicate a potential earnings beat. However, the overall outlook remains cautious as the company navigates these financial challenges.
growth-positive
Centers for Medicare and Medicaid Services Assigns Permanent J Code for ZUSDURI™ Effective January 1, 2026
UroGen Pharma Ltd. announced that the Centers for Medicare and Medicaid Services (CMS) has assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II J Code, J9282, for ZUSDURI, an FDA-approved treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). This J Code, effective January 1, 2026, will streamline billing and claims submission, facilitating easier access to the treatment. ZUSDURI, utilizing UroGen’s RTGel® technology, is delivered directly into the bladder, offering a non-surgical treatment option. The assignment of a J Code is a significant milestone for UroGen, simplifying reimbursement processes and reducing administrative barriers for healthcare providers.
Product StageFDA approved/pending approval
| Sector | Health Tech & Life Sciences |
Funding
| Total funding | $522.2M |
| Last funding | $107.5M |
| Stage | Public |
| Rounds | 10 |
| Investors | 8 |
Team Members
3
Employees: 201-500
Web & Social Links
| Website | www.urogen.com |
| Careers | Careers page |
Locations
Ha-Ta'asiya Street 9, Ra'anana, Israel
400 Alexander Park Drive, Princeton, NJ, USA
Photos & Videos
No files yet
UroGen Pharma Business
Business models
B2B
Product stage
Clinical Trial
Employees
201-500
Sector
Health Tech & Life SciencesPharma & Medical BiotechnologyDrugs Discovery & DevelopmentDrug DeliveryTarget Customer
ConsumersDemographics & FamilyMenHealthcare & Life SciencesHealthcarePatientsLife SciencesPharmaceuticalsCore Technology
BiologicalsCellsTags (10)
oncologydrug-deliverysustained-releaseurologypharmaceuticalsorphan-drugnon-surgicalpharma-companiesdrug-designcancerGeographic Markets
EuropeUnited StatesIsraelUroGen Pharma Financials
$522.2M
Total funding
Undisclosed
Capital raised
$107.5M
Last funding
Public
Funding stage
10
Total rounds
8
Investors
Cumulative Funding Raised Over Time ($)
$1.5MJan 2010
$121.5MJul 2023
$196.5MMar 2021
$296.5MMar 2022
$303.5MMay 2013
$321.5MNov 2015
Private Equity Funding
PIPE
Jul 2023
$120M
Great Point Partners (Lead), RA Capital Management (Lead)
,
Acorn Bioventures, Monograph Capital, The Horton Fund
Debt Financing
Mar 2022
$100M
Undisclosed Investor(s)
Debt Financing
Mar 2021
$75M
Undisclosed Investor(s)
A Round
Nov 2015
$18M
Two River
A Round
May 2013
$7M
Pontifax
Seed
Jan 2010
$1.5M
Pontifax
Public Offering / Exit
POEvent
Jun 2024
Undisclosed
POEvent
Jan 2019
Undisclosed
POEvent
Jan 2018
Undisclosed
POEvent
May 2017
Undisclosed
UroGen Pharma Lifecycle
Cumulative Funding Raised Over Time
$1.5MJan 2010
$121.5MJul 2023
$196.5MMar 2021
$296.5MMar 2022
$303.5MMay 2013
$321.5MNov 2015
All Events
PIPE
Jul 2023
$120M
Great Point Partners (Lead), RA Capital Management (Lead)
,
Acorn Bioventures, Monograph Capital, The Horton Fund
Debt Financing
Mar 2022
$100M
Undisclosed Investor(s)
Debt Financing
Mar 2021
$75M
Undisclosed Investor(s)
A Round
Nov 2015
$18M
Two River
A Round
May 2013
$7M
Pontifax
Seed
Jan 2010
$1.5M
Pontifax
POEvent
Jun 2024
Undisclosed
POEvent
Jan 2019
Undisclosed
POEvent
Jan 2018
Undisclosed
POEvent
May 2017
Undisclosed
UroGen Pharma News
209 articles
growth-positive
Biogen Inc. (BIIB) Q3 Earnings and Revenues Top Estimates
Biogen Inc. reported quarterly earnings of $4.81 per share, surpassing the Zacks Consensus Estimate of $3.89 per share, marking a 23.65% earnings surprise. The company also reported revenues of $2.53 billion, exceeding the consensus estimate by 8.31%. Despite these positive results, Biogen shares have declined by about 3.3% since the start of the year, underperforming the S&P 500s gain of 17.2%. The companys earnings outlook and estimate revisions will be crucial for future stock performance. Currently, Biogen holds a Zacks Rank #3 (Hold), indicating expected market performance alignment in the near term.
growth-positive
Adherex Technologies Inc. (FENC) May Report Negative Earnings: Know the Trend Ahead of Q3 Release
Adherex Technologies Inc. (FENC) is expected to report a year-over-year increase in earnings and revenues for the quarter ending September 2025. The company is anticipated to post a quarterly loss of $0.08 per share, representing a 61.9% improvement from the previous year, with revenues expected to rise by 60.3% to $11.17 million. The consensus EPS estimate has been revised significantly lower over the past 30 days, reflecting a reassessment by analysts. The Zacks Earnings ESP model suggests that a positive earnings surprise is likely, especially if combined with a strong Zacks Rank. This could lead to a positive impact on the companys stock price.
growth-positive
UroGen Pharma to Report Third Quarter 2025 Financial Results on Thursday, November 6th, 2025
UroGen Pharma Ltd., a biotech company focused on developing treatments for urothelial and specialty cancers, announced it will report its third-quarter 2025 financial results on November 6th, 2025. The announcement will be followed by a live webcast and conference call. UroGen has developed RTGel® reverse-thermal hydrogel, a platform technology that enhances the therapeutic profiles of existing drugs. The company has two FDA-approved products for treating low-grade upper tract urothelial cancer and recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The webcast will be accessible on UroGens Investor Relations website, with a replay available for 30 days.
Public Trading
growth-negative
Urogen Pharma (URGN) Expected to Beat Earnings Estimates: Should You Buy?
Urogen Pharma (URGN) is anticipated to report a year-over-year decline in earnings despite higher revenues for the quarter ending September 2025. The company is expected to post a quarterly loss of $0.72 per share, a 30.9% decrease from the previous year, while revenues are projected to rise by 22.9% to $30.98 million. The consensus EPS estimate has been revised downwards by 5.91% over the last 30 days. The Zacks Earnings ESP model suggests that a positive Earnings ESP, combined with a strong Zacks Rank, could indicate a potential earnings beat. However, the overall outlook remains cautious as the company navigates these financial challenges.
growth-positive
Centers for Medicare and Medicaid Services Assigns Permanent J Code for ZUSDURI™ Effective January 1, 2026
UroGen Pharma Ltd. announced that the Centers for Medicare and Medicaid Services (CMS) has assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II J Code, J9282, for ZUSDURI, an FDA-approved treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). This J Code, effective January 1, 2026, will streamline billing and claims submission, facilitating easier access to the treatment. ZUSDURI, utilizing UroGen’s RTGel® technology, is delivered directly into the bladder, offering a non-surgical treatment option. The assignment of a J Code is a significant milestone for UroGen, simplifying reimbursement processes and reducing administrative barriers for healthcare providers.
Product StageFDA approved/pending approval
growth-positive
MeiraGTx (MGTX) Moves 12.4% Higher: Will This Strength Last?
MeiraGTx Holdings PLC experienced a significant 12.4% increase in its stock price, closing at $9.26, driven by heightened investor confidence in its late-stage clinical programs targeting conditions such as Parkinsons disease and AIPL1-associated retinal dystrophy. Despite the positive stock movement, the company is expected to report a quarterly loss of $0.51 per share, with revenues projected to decline by 59.4% compared to the previous year. The stocks recent performance is attributed to the promising potential of its genetic medicine programs, which aim to address severe unmet medical needs. MeiraGTx is part of the Zacks Medical - Biomedical and Genetics industry and currently holds a Zacks Rank #3 (Hold).
Product Stage
growth-positive
ZUSDURI™ Clinical Review Published in Reviews in Urology™ Highlights Durable Efficacy and Manageable Safety Profile in Recurrent Low-Grade, Intermediate-Risk Non–Muscle Invasive Bladder Cancer
UroGen Pharma Ltd. announced the publication of a comprehensive review of its FDA-approved drug, ZUSDURI™ (mitomycin), for treating recurrent, low-grade, intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). The review, published in the journal Reviews in Urology™, highlights the drugs high complete response rates and durable disease response, as demonstrated in clinical trials such as OPTIMA II, ATLAS, and ENVISION. ZUSDURI has a manageable safety profile with primarily mild to moderate adverse reactions. The drug is administered in an outpatient setting and does not require general anesthesia, making it a convenient option for patients. The publication underscores ZUSDURIs role as an innovative treatment for LG-IR-NMIBC.
Product Stage
growth-positive
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
UroGen Pharma Ltd., a biotech company focused on urothelial and specialty cancers, announced the grant of inducement restricted stock units (RSUs) to 40 new employees. These employees will aid in the commercialization of UroGens products, Jelmyto® and ZUSDURI™, and support the development of its pipeline. The RSUs, part of UroGens 2019 Inducement Plan, will vest over three years. UroGens products are FDA-approved and designed to treat cancers non-surgically. The company is headquartered in Princeton, New Jersey, with operations in Israel.
Expand
growth-positive
UroGen Pharma to Present at Upcoming Investor Conferences
UroGen Pharma Ltd., a biotech company focused on developing treatments for urothelial and specialty cancers, announced its participation in several investor conferences in September 2025. The company will present at the Wells Fargo Healthcare Conference, Cantor Fitzgerald Global Healthcare Conference, and H.C. Wainwright 27th Annual Global Healthcare Conference. UroGen has developed RTGel® reverse-thermal hydrogel, a platform technology aimed at improving drug therapeutic profiles. The company has two FDA-approved products for treating urothelial cancers. These conferences provide UroGen an opportunity to engage with investors and showcase their innovative solutions.
growth-negative
UroGen Pharma Ltd. (NASDAQ:URGN) Just Released Its Second-Quarter Results And Analysts Are Updating Their Estimates
UroGen Pharma Ltd. recently released its quarterly results, which led to an 8.5% drop in its share price. Despite revenues of US$24 million beating expectations by 4.7%, statutory losses increased by 28% to US$1.05 per share, causing concern among investors. Analysts have adjusted their forecasts, predicting revenues of US$122.3 million in 2025, a 30% increase from the past year, but also expecting losses to shrink by 12% to US$2.94 per share. The consensus price target remains at US$34.63, indicating that higher forecast losses are not expected to impact long-term valuation significantly. UroGen Pharmas growth rate is expected to accelerate, with a forecasted 68% annualized revenue growth by 2025, outpacing the industry average of 19%.
growth-positive
UroGen Pharma Ltd (URGN) Q2 2025 Earnings Call Highlights: FDA Approval and Revenue Growth ...
UroGen Pharma Ltd has achieved FDA approval for its new drug, Zourri, intended for treating recurrent, low-grade, intermediate-risk, non-muscle invasive bladder cancer. This marks a significant milestone for the company. The company reported a strong second-quarter net product revenue of $24.2 million for Gelmio, an 11% increase from the previous year. UroGen has expanded its sales force to 82 representatives to reach a larger portion of healthcare providers. Despite a net loss of $49.9 million for the quarter, the company is optimistic about Zourris market uptake, especially post-J code assignment in 2026. Challenges remain with reimbursement logistics, but there is strong interest from healthcare providers.
Product StageExpand
Not specified
Sector Update: Health Care Stocks Decline Late Afternoon
The article mentions that health care stocks were slipping late Thursday afternoon, with the NYSE Health Care Index down 1%. It suggests that a Silver or Gold subscription plan is required to access premium news articles from MT Newswires. The article does not provide specific details about any particular company, its impact, or any structured issues related to investments, partnerships, or acquisitions.
growth-positive
UroGen Pharma Expands Commercial Portfolio with Launch of ZUSDURI™ and Reports Second Quarter 2025 Financial Results
UroGen Pharma Ltd. announced the FDA approval of ZUSDURI, the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). This approval marks a significant milestone for UroGen, positioning it as a multi-product uro-oncology company. The company reported net product sales of $24.2 million for JELMYTO in Q2 2025, an 11% increase from the previous year. With $161.6 million in cash and securities, UroGen is well-positioned to support the ZUSDURI launch and pursue strategic initiatives. The company is also advancing its pipeline, including next-generation mitomycin formulations and immuno-oncology candidates.
Product StageFDA approved/pending approval
growth-negative
Urogen Pharma (URGN) Reports Q2 Loss, Lags Revenue Estimates
Urogen Pharma reported a quarterly loss of $1.05 per share, which was worse than the Zacks Consensus Estimate of a $0.82 loss. This represents an earnings surprise of -28.05%. The company posted revenues of $24.22 million, missing the consensus estimate by 0.96%. Despite these results, Urogen Pharma shares have increased by 87.9% since the beginning of the year, outperforming the S&P 500s gain of 7.9%. The companys earnings outlook and estimate revisions will be crucial for future stock performance. Currently, Urogen Pharma holds a Zacks Rank #3 (Hold), indicating expected performance in line with the market.
growth-positive
UroGen’s Zusduri benefit maintained in NMIBC Phase III study
UroGen Pharmas Zusduri (mitomycin) has been approved as the first non-surgical therapy for non-muscular invasive bladder cancer (NMIBC), marking a significant milestone in cancer treatment. The Phase III ENVISION trial demonstrated sustained efficacy, with a two-year duration of response in 72.2% of patients. Approved in June 2025, Zusduri is expected to reach $449 million in sales by 2031. It faces competition from MSDs Keytruda and Ferring Pharmaceuticals Adstiladrin, which are approved for high-risk patients. The approval positions Zusduri as a transformative option for recurrent LG-IR-NMIBC patients, offering a durable treatment alternative.
Product Stage
growth-positive
UroGen Announces 24-Month Duration of Response of 72.2% from the Pivotal Phase 3 ENVISION Trial of ZUSDURI, the First and Only FDA-Approved Medicine for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
UroGen Pharma Ltd. announced a significant milestone with the FDA approval of ZUSDURI™ (mitomycin) for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The Phase 3 ENVISION trial demonstrated a 24-month duration of response (DOR) of 72.2% in patients who achieved a complete response at three months. This approval marks a transformative step in managing this chronic cancer, offering a new outpatient treatment option that can provide a clinically meaningful recurrence-free interval. The approval is expected to positively impact UroGen Pharma by providing a durable treatment option for patients, reducing the need for repeated surgeries.
Product Stage
growth-positive
LENZ Therapeutics, Inc. (LENZ) Reports Q2 Loss
LENZ Therapeutics, Inc. reported a quarterly loss of $0.53 per share, surpassing the Zacks Consensus Estimate of a $0.58 loss, marking an earnings surprise of +8.62%. The company posted revenues of $5 million for the quarter ended June 2025, compared to zero revenues a year ago. LENZ shares have increased by about 9.7% since the beginning of the year, outperforming the S&P 500s gain of 8.3%. The companys earnings outlook remains favorable, with a Zacks Rank #2 (Buy), indicating expected market outperformance in the near future. The current consensus EPS estimate for the coming quarter is -$0.70 on $5.63 million in revenues.
growth-positive
UroGen Pharma (URGN) Presented Real-World Study of JELMYTO at 2025 American Society of Clinical Oncology
UroGen Pharma Ltd. (NASDAQ:URGN) presented its uTRACT Registry study design at the 2025 American Society of Clinical Oncology, focusing on the real-world study of JELMYTO, a treatment for low-grade upper tract urothelial carcinoma. The study, conducted across 22 sites in the U.S., has enrolled 274 patients as of May 2025, aiming for 400 registries. The study will provide insights into treatment patterns, safety, effectiveness, and outcomes over three years. The treatment is under FDA review, and the study is expected to offer valuable data. UroGen Pharma is a biopharmaceutical company developing cancer and urologic disease treatments.
Product StageFDA approved/pending approval
growth-positive
UroGen Pharma to Report Second Quarter 2025 Financial Results on Thursday, August 7th, 2025
UroGen Pharma Ltd., a biotech company focused on developing treatments for urothelial and specialty cancers, will report its second quarter 2025 financial results on August 7th, 2025. The announcement will be followed by a live webcast and conference call. UroGen has developed RTGel, a proprietary hydrogel-based platform technology, and has two FDA-approved products for treating specific types of cancer. The company is headquartered in Princeton, NJ, with operations in Israel. The webcast will be accessible on UroGens Investor Relations website, with a replay available for 30 days.
growth-positive
UroGen Announces Publication of Phase 3b Study Results Demonstrating the Feasibility of Home Instillation of ZUSDURI™ for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer in Reviews in Urology
UroGen Pharma Ltd. announced positive results from a Phase 3b study on the feasibility of administering ZUSDURI™ (mitomycin) for intravesical solution at home for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The study demonstrated that trained home health professionals can safely and effectively administer the treatment outside of a traditional clinical setting, potentially easing the burden on patients and reducing reliance on hospital resources. The study showed a 75% complete response rate at three months, with no new safety concerns. This approach reflects UroGens commitment to providing effective and convenient treatment options for urologic cancers.
Product Stage
growth-positive
High Growth Tech Stocks In The US Market
UroGen Pharma Ltd. is a biotechnology company focused on developing treatments for urothelial and specialty cancers. The company has a market cap of $783.57 million and generates revenue primarily from its biotechnology segment. UroGen Pharmas recent advancements include the FDA approval of ZUSDURI and ongoing Phase 3 UTOPIA trial, highlighting its focus on R&D and innovation in non-muscle invasive bladder cancer treatments. The company invests significantly in its proprietary RTGel® technology, which aids in sustained drug release. Despite regulatory challenges, UroGens robust pipeline and strategic R&D spending are crucial for its success in the competitive biotech landscape.
Product StageFDA approved/pending approval
growth-negative
UroGen Pharma Ltd. (NASDAQ:URGN) Is Expected To Breakeven In The Near Future
UroGen Pharma Ltd., a company focused on developing solutions for urothelial and specialty cancers, is facing financial challenges with a recent loss of US$138 million. Analysts expect the company to reach breakeven by 2027, requiring an average annual growth rate of 67%. Despite the negative equity on its balance sheet, which may be due to accumulated losses, analysts remain optimistic about the companys future profitability. The article highlights the importance of understanding UroGen Pharmas financial fundamentals and the potential risks associated with its current financial position.
growth-positive
UroGen Announces Five-Year Long-Term Extension Study of the OPTIMA II Trial Demonstrates Long-Term Durability of Response to ZUSDURI™ in Patients with Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
UroGen Pharma Ltd. announced positive results from a five-year long-term extension study of their Phase 2b OPTIMA II trial for ZUSDURI (mitomycin) in treating low-grade intermediate-risk non-muscle invasive bladder cancer. The study, published in the Journal of Clinical Genitourinary Cancer, showed that patients who achieved complete response had a median event-free duration of two years, with some extending to 3.5 years. The findings highlight ZUSDURIs potential as a non-surgical treatment option, offering sustained responses and meaningful, lasting event-free periods for recurrent patients. This development underscores UroGens commitment to providing innovative cancer treatments.
Product Stage
growth-positive
UroGen concludes enrolment in Phase III trial of UGN-103 for bladder cancer
UroGen Pharma has completed the enrolment of 99 subjects in its Phase III UTOPIA trial for UGN-103, a therapy for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The trial aims to assess the efficacy and safety of UGN-103, which uses RTGel technology for prolonged bladder exposure and sustained drug release. The primary goal is to achieve a complete response rate at three months, with a follow-up phase to evaluate response durability. UGN-103 is positioned as a next-generation formulation offering improvements over Zusduri. The company has a licensing and supply deal with medac and has secured patent protection for UGN-103 until December 2041.
Product StagePartners
growth-positive
UroGen Announces Completion of Enrollment in the Phase 3 UTOPIA Clinical Trial of UGN-103 for the Treatment of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
UroGen Pharma Ltd. has completed patient enrollment for its Phase 3 UTOPIA clinical trial of UGN-103, a next-generation formulation for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The trial involves 99 patients globally and aims to evaluate the efficacy and safety of UGN-103, which uses UroGen’s RTGel® technology for sustained drug release. The company has a licensing and supply agreement with medac for developing UGN-103, which is expected to offer improvements over the existing ZUSDURI™ formulation. UroGen has received a Notice of Allowance from the U.S. Patent and Trademark Office, ensuring patent protection until December 2041.
Product StagePartners
growth-positive
UroGen Pharma Receives FDA Approval for ZUSDURI for Recurrent Bladder Cancer
UroGen Pharma Ltd. has received FDA approval for ZUSDURI, a mitomycin-based intravesical solution for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. This marks ZUSDURI as the first FDA-approved medication for this condition, utilizing UroGens proprietary RTGel technology for non-surgical tumor ablation. The approval is backed by positive results from the Phase 3 ENVISION trial, showing a high complete response rate among patients. While UroGen Pharma is recognized as a promising investment, the article suggests that certain AI stocks may offer greater potential. The article was originally published by Insider Monkey.
Product StageFDA approved/pending approval
growth-positive
H.C. Wainwright Sees Billion Dollar Potential in UroGen’s New Therapy
UroGen Pharma Ltd. (NASDAQ:URGN) has received a significant boost as analysts at H.C. Wainwright upgraded its stock rating to Buy with a price target of $50. This follows the regulatory approval of Zusduri, priced at $21,500 per dose, aimed at treating non-muscle invasive bladder cancer. The companys stock price has surged over 100% in the past five days, with expectations of further growth. UroGen Pharma, a clinical-stage biopharmaceutical company, is set to launch its product, targeting a market of 59,000 patients annually in the U.S. The treatment is projected to generate $1 billion in sales by 2026. Despite potential changes in clinical trial strategies, the financial outlook remains positive.
Product StageFDA approved/pending approval
growth-positive
AstraZeneca forms an AI deal in China; Third Harmonic advances liquidation plans
AstraZeneca has formed a new collaboration with CSPC Pharmaceutical Group to develop oral medicines using AI technology for immunological diseases and other chronic conditions. The deal involves an upfront payment of $110 million to CSPC and potential additional payments up to $5.2 billion based on development and sales milestones. This partnership builds on AstraZenecas previous investments in China, including a $2.5 billion R&D center in Beijing and collaborations with other Chinese biotechs. The collaboration is part of AstraZenecas strategy to deepen its presence in the Chinese market and leverage AI in drug discovery.
PartnersInvestment
growth-positive
High Growth Tech Stocks in US for June 2025
Soleno Therapeutics, Inc., a clinical-stage biopharmaceutical company, is focused on developing treatments for rare diseases. The company is currently in a transformative phase with its VYKAT™ XR for Prader-Willi syndrome, which has received FDA approval and is seeking EU exclusivity. Despite a net loss of $43.77 million in Q1 2025, Soleno is projected to achieve robust annual revenue growth of 53.4% and an earnings surge of 65.09% per year. This positions the company favorably in the market, especially given the significant unmet needs in the Prader-Willi syndrome market.
Product StageFDA approved/pending approval
growth-positive
U.S. FDA Approves UroGen’s ZUSDURI™ (mitomycin) for Intravesical Solution as the First and Only Medication for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)
UroGen Pharma Ltd. has announced that the U.S. FDA has approved ZUSDURI, a medication for recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). This approval is based on the successful results of the Phase 3 ENVISION trial, which showed a 78% complete response rate at 3 months, with 79% of responders maintaining this response at 12 months. ZUSDURI, utilizing UroGens RTGel technology, offers a new treatment alternative to the traditional surgical procedure, TURBT. This approval marks a significant milestone for UroGen, providing a new FDA-approved option for the estimated 59,000 U.S. patients with recurrent LG-IR-NMIBC each year.
Product StageFDA approved/pending approval
growth-positive
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
UroGen Pharma Ltd., a biotech company focused on urothelial and specialty cancers, announced the grant of inducement restricted stock units (RSUs) to 27 new employees. These employees will aid in the commercialization of Jelmyto®, UroGens first approved product, and the development of its pipeline. The RSUs, part of UroGens 2019 Inducement Plan, will vest over three years. UroGens proprietary RTGel® technology aims to improve drug therapeutic profiles, offering better treatment options for patients. The company is headquartered in Princeton, New Jersey, with operations in Israel.
Expand
growth-positive
UroGen Announces Data at ASCO 2025 Annual Meeting on UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)
UroGen Pharma Ltd. presented new data from its Phase 3 ENVISION and ATLAS clinical studies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The studies focus on UGN-102, an investigational therapy for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The data highlights the 18-month duration of response (DOR) and the impact of tumor burden on treatment efficacy. UGN-102 utilizes UroGens RTGel® technology to enhance bladder tissue exposure to mitomycin. The FDA has accepted the new drug application for UGN-102, with a target action date set for June 13, 2025. An FDA advisory committee recently voted on the benefit/risk profile of UGN-102.
Product StageFDA approved/pending approval
growth-positive
UroGen Presents uTRACT Registry at ASCO 2025 Annual Meeting Designed to Study Real-World Use of JELMYTO in Low-Grade Upper Tract Urothelial Cancer
UroGen Pharma Ltd. presented the uTRACT Registry study design at the 2025 ASCO Annual Meeting, focusing on the real-world use of JELMYTO for treating low-grade upper tract urothelial carcinoma (LG-UTUC). The study aims to enroll 400 patients, with 274 already participating across 22 sites. It will collect comprehensive data over three years to assess clinical outcomes, including disease presence, response duration, and recurrence-free survival. JELMYTO, an FDA-approved mitomycin-containing gel, is used for chemoablative therapy in the urinary tract. The studys insights are expected to inform best practices and support JELMYTOs clinical utility.
Product StageFDA approved
growth-positive
UroGen Pharma to Present at TD Cowen: 6th Annual Oncology Innovation Summit: Insights for ASCO & EHA
UroGen Pharma Ltd., a biotech company focused on developing innovative treatments for urothelial and specialty cancers, announced its participation in the TD Cowen: 6th Annual Oncology Innovation Summit. The company has developed RTGel® reverse-thermal hydrogel, a platform technology designed to improve drug therapeutic profiles. UroGens products, including a treatment for LG-UTUC and an investigational treatment UGN-102 for bladder cancer, aim to provide non-surgical tumor ablation options. The summit participation is a positive step for UroGen, showcasing its innovative solutions to a wider audience. The event will be held virtually on May 28, 2025.
growth-negative
UroGen Announces Outcome of Oncologic Drugs Advisory Committee for UGN-102 for the Treatment of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)
UroGen Pharma Ltd., a biotech company focused on urothelial and specialty cancers, announced the outcome of the FDAs Oncologic Drugs Advisory Committee (ODAC) meeting regarding their investigational drug UGN-102 for recurrent LG-IR-NMIBC. The ODAC narrowly voted against the drugs benefit/risk profile, which is a setback for UroGen as they await the FDAs final decision. Despite the vote, UroGen remains committed to the drugs development, citing high unmet needs in treating this type of cancer. The NDA for UGN-102 is under FDA review with a PDUFA date set for June 13, 2025.
Product StageFDA approved/pending approval
growth-positive
Biotech Alert: Searches spiking for these stocks today
Inozyme Pharma, a clinical-stage biopharmaceutical company, is experiencing a significant surge in interest, with a 1,125% increase in search activity. The company is focused on developing innovative therapeutics targeting the PPi-Adenosine Pathway, crucial for bone health and blood vessel function. Its lead therapy, INZ-701, is in late-stage clinical development for ENPP1 Deficiency and has potential applications for other conditions like ABCC6 Deficiency and calciphylaxis. This surge in interest reflects a growth-positive impact on the company, highlighting its promising therapeutic developments in the biotech sector.
Product Stage
growth-negative
UroGen Pharma Ltd. (NASDAQ:URGN) Just Reported Earnings, And Analysts Cut Their Target Price
UroGen Pharma Ltd. recently released its quarterly results, which fell short of analyst expectations. The company reported a revenue of $20 million, which was 11% below forecasts, and a statutory loss of $0.92 per share, 18% greater than expected. Analysts have updated their earnings models, predicting a 30% revenue increase to $119.7 million in 2025, but also a slight increase in forecasted losses per share to $2.87. The average price target for UroGen Pharma has decreased by 6.4% to $32.63, reflecting concerns over growing losses. Despite these challenges, UroGen Pharma is expected to grow faster than the broader industry, with a forecasted annual revenue growth of 42% by 2025.
growth-positive
UroGen Pharma Ltd (URGN) Q1 2025 Earnings Call Highlights: Strong Jelmyto Sales and Promising ...
UroGen Pharma Ltd reported a strong performance in Q1 2025, with Jelmyto sales reaching $20.3 million, marking an 8% year-over-year growth. The company is in the final stages of FDA review for UGN-102, with a PDUFA target date set for June 13, 2025. UGN-102 is expected to be a significant growth driver, with a market opportunity exceeding $5 billion. UroGen is expanding its sales force in anticipation of UGN-102s launch. Despite a net loss of $43.8 million, the company maintains a robust balance sheet with over $200 million in cash equivalents. The ENVISION trial for UGN-102 showed promising results, although concerns remain about its single-arm study design.
Product StageExpand
growth-negative
Urogen Pharma (URGN) Reports Q1 Loss, Lags Revenue Estimates
Urogen Pharma reported a quarterly loss of $0.92 per share, missing the Zacks Consensus Estimate of a loss of $0.83. This represents an earnings surprise of -10.84%. The companys revenues for the quarter were $20.25 million, which also missed the consensus estimate by 3.67%. Over the last four quarters, Urogen Pharma has surpassed consensus EPS estimates only once. The companys shares have lost about 2.5% since the beginning of the year, outperforming the S&P 500s decline of -3.8%. The earnings outlook remains mixed, with a Zacks Rank of #3 (Hold), indicating that the shares are expected to perform in line with the market in the near future.
growth-positive
UroGen Pharma Reports First Quarter 2025 Financial Results and Provides a Business Update
UroGen Pharma Ltd., a biotech company focused on urothelial and specialty cancers, announced its financial results for Q1 2025 and provided updates on its lead product, UGN-102. The New Drug Application (NDA) for UGN-102, intended for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, is under review by the FDA. The FDA has set a target action date of June 13, 2025, with an advisory committee meeting scheduled for May 21, 2025. Assuming approval, UroGen plans to launch the product commercially in July 2025. The company reported net sales of $20.3 million for JELMYTO® in Q1 2025, reflecting a 12% demand growth. UroGen is well-positioned financially with $200.4 million in cash and marketable securities, aiming to transform uro-oncology treatment and deliver shareholder value.
Product StageFDA approved/pending approval
growth-positive
UroGen Announces FDA Advisory Committee for UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
UroGen, a biotech company, announced that the FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting on May 21, 2025, to review the new drug application (NDA) for UGN-102, an investigational treatment for recurrent LG-IR-NMIBC. The NDA is supported by positive results from the Phase 3 ENVISION trial, showing a high complete response rate. The FDA aims to complete its review by the PDUFA target action date of June 13, 2025. UGN-102, utilizing UroGens RTGel technology, offers a non-surgical treatment option for bladder cancer. The company is optimistic about the potential approval and its impact on patients.
Product Stage
growth-positive
UroGen Pharma to Report First Quarter 2025 Financial Results on Monday, May 12, 2025
UroGen Pharma Ltd., a biotech company focused on developing treatments for urothelial and specialty cancers, announced it will report its first quarter 2025 financial results on May 12, 2025. The announcement will be followed by a live audio webcast and conference call. UroGen has developed RTGel® reverse-thermal hydrogel, a platform technology designed to improve the therapeutic profiles of existing drugs. Their products aim to treat low-grade upper tract urothelial carcinoma (LG-UTUC) and recurrent low-grade non-muscle invasive bladder cancer using non-surgical methods. The company is headquartered in Princeton, NJ, with operations in Israel.
growth-positive
Urogen Pharma (URGN) Moves 14.1% Higher: Will This Strength Last?
Urogen Pharmas stock rose by 14.1% to $11.26 following the presentation of data on its pipeline candidates at the American Urological Association 2025 meeting. The company is expected to report a quarterly loss of $0.83 per share, a 14.4% improvement year-over-year, with revenues projected at $21.03 million, up 12% from the previous year. Despite the positive stock movement, the consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Urogen Pharma is part of the Zacks Medical - Biomedical and Genetics industry and currently holds a Zacks Rank #3 (Hold).
growth-positive
New Long-Term Follow-Up Data from OPTIMA II Study of UGN-102 Demonstrates Median Duration of Response of Two Years in Patients with LG-IR-NMIBC
UroGen Pharma Ltd. presented new data from their OPTIMA II Phase 2b study at the American Urological Association 2025 Annual Meeting. The study focuses on UGN-102, a sustained-release formulation of mitomycin for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The data shows a median duration of response of 24.2 months, highlighting the treatments durability. UroGen completed the submission of a rolling new drug application for UGN-102 to the FDA in August 2024, with a PDUFA goal date set for June 13, 2025. These results emphasize the potential of UGN-102 to provide meaningful and sustained responses for patients with limited treatment options.
Product StageFDA approved/pending approval
growth-positive
New Patient-Reported Outcomes from UGN-102 Clinical Trials Show the Investigational Treatment Did Not Adversely Affect Functionality, Symptom Burden, and Quality of Life in Patients with LG-IR-NMIBC
UroGen Pharma Ltd. presented new analysis of patient-reported outcomes from the OPTIMA II, ATLAS, and ENVISION studies of their investigational drug UGN-102 at the AUA 2025 Annual Meeting. The data showed that UGN-102 achieved robust and durable complete response rates in patients with low-grade intermediate-risk non-muscle invasive bladder cancer without negatively impacting their quality of life. The findings suggest that UGN-102 is a promising alternative intravesical treatment for these patients. The company emphasized the importance of advancing treatment options that improve patient outcomes and quality of life.
Product Stage
growth-positive
OLYMPUS Long-Term Follow-Up Study Reports Nearly Four-Year Duration of Response in Subset of Patients with Low-Grade Upper Tract Urothelial Cancer Who Achieved a Complete Response to Initial JELMYTO Treatment
UroGen Pharma Ltd. presented data at the 2025 American Urological Association Annual Meeting highlighting the long-term effectiveness of JELMYTO, an FDA-approved treatment for low-grade upper tract urothelial cancer (LG-UTUC). The study showed a median duration of response of nearly four years among patients who achieved a complete response after primary chemoablation with JELMYTO. The findings underscore the treatments durability and its potential to significantly reduce recurrence rates in both new-onset and recurrent LG-UTUC patients. The studys limitations include its post-hoc nature and potential selection bias. UroGen plans to further evaluate JELMYTOs potential through the ongoing uTRACT Registry.
Product Stage
growth-positive
UroGen Announces Updated 18-Month Duration of Response (DOR) of 80.6% from the Phase 3 ENVISION Trial of UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)
UroGen Pharma Ltd. announced promising results from its Phase 3 ENVISION trial for UGN-102, an investigational treatment for recurrent low-grade non-muscle invasive bladder cancer (LG-IR-NMIBC). The trial demonstrated an 18-month duration of response (DOR) of 80.6% in patients who achieved a complete response at three months. The data was presented at the American Urological Association 2025 Annual Meeting. UGN-102 aims to provide a non-surgical treatment option for elderly patients who face the burden of repeated surgeries. If approved, UGN-102 could significantly impact the treatment landscape by reducing recurrence rates and extending treatment-free intervals.
Product Stage
growth-positive
UroGen Pharma Announces Encouraging Results from a Phase 1 Dose-Escalation Study Evaluating UGN-301 in Non-Muscle Invasive Bladder Cancer
UroGen Pharma Ltd. announced positive safety data from its Phase 1 dose-escalation study for UGN-301, an investigational drug for recurrent non-muscle invasive bladder cancer. The study, presented at the 2025 American Urological Association Annual Meeting, showed that UGN-301 was well-tolerated across all dose levels with no dose-limiting toxicities. The drug, formulated in a reverse thermal gel, allowed sustained exposure in the bladder, reducing systemic immune-related toxicities. Clinical activity was observed, with a significant percentage of patients achieving a complete response or remaining recurrence-free. These promising results support further investigation into UGN-301s efficacy.
Product Stage
growth-positive
UroGen Announces Data Presentations at the American Urological Association 2025 Annual Meeting Highlighting Emerging Evidence Supporting Our Portfolio for Urothelial Cancers
UroGen Pharma Ltd., a biotech company focused on developing treatments for urothelial and specialty cancers, announced the presentation of new data at the American Urological Association (AUA) 2025 Annual Meeting. The data includes 18-month duration of response (DOR) from the ENVISION trial for UGN-102, long-term outcomes from the OPTIMA II study, and results from a Phase 1 study for UGN-301. These findings highlight the potential of UroGens portfolio in advancing the treatment of urothelial cancers. The company is also participating in the AUA Innovation Nexus Conference, showcasing its involvement in innovative urology solutions.
Product StagePublic Trading
growth-positive
High Growth Tech Stocks In The US To Watch April 2025
Organogenesis Holdings Inc., a regenerative medicine company, has demonstrated significant growth potential in the biotech sector. The company focuses on advanced wound care and surgical products, generating substantial revenue from its regenerative medicine segment. In Q4, Organogenesis reported a notable increase in sales to $126.66 million, up from $99.65 million the previous year, and achieved a net income of $7.67 million, reversing a previous net loss. The companys annual sales rose to $482.04 million, marking a steady growth rate of 9.2% per year, surpassing the US market average. Despite current unprofitability and share price volatility, Organogenesis is projected to achieve profitability within three years, with expected earnings growth of 71.83% annually, indicating strong future prospects.
growth-positive
UroGen Pharma Ltd (URGN) Q4 2024 Earnings Call Highlights: Strategic Advances and Financial ...
UroGen Pharma Ltd has submitted a new drug application for UGN 102, with FDA review underway and a target date set for June 13th. The Envision phase 3 trial showed promising results, and the company is expanding its sales force in anticipation of the drugs launch. Despite reporting a net loss for 2024, UroGen Pharma has a strong balance sheet and a 12% increase in sales for its existing product, Jelmyto. The company faces potential challenges with market access and reimbursement due to a generic J code but remains optimistic about UGN 102s revenue potential. The company is also considering pricing strategies and further clinical work.
Product StageExpand
growth-negative
Urogen Pharma (URGN) Reports Q4 Loss, Lags Revenue Estimates
Urogen Pharma reported a quarterly loss of $0.80 per share, missing the Zacks Consensus Estimate of a $0.74 loss. This represents an earnings surprise of -8.11%. The company posted revenues of $24.57 million, also missing the consensus estimate by 6.08%. Over the last four quarters, Urogen Pharma has surpassed consensus EPS estimates only once. The companys shares have declined by about 7.8% since the beginning of the year, underperforming the S&P 500s decline of -1.9%. The companys earnings outlook remains mixed, with a Zacks Rank of #3 (Hold), indicating expected performance in line with the market. Future stock movements will depend on managements commentary and earnings estimate revisions.
growth-positive
UroGen Pharma Reports Fourth Quarter and Full Year 2024 Financial Results and Announces Updated 18-Month Duration of Response (DOR) of 80.6% from the Phase 3 ENVISION Trial of UGN-102
UroGen Pharma Ltd. announced significant progress in 2024, including the submission of a New Drug Application (NDA) for UGN-102, which is under FDA review with a PDUFA target action date set for June 13, 2025. The company reported promising 18-month duration of response (DOR) data from the Phase 3 ENVISION trial for UGN-102, a treatment for low-grade intermediate-risk non-muscle invasive bladder cancer. UroGen also acquired ICVB-1042, an investigational oncolytic virus therapy, and achieved revenue growth with its product JELMYTO®. The company is well-positioned for future growth with a strong pipeline and strategic acquisitions.
Product StageAcquisition
growth-positive
Exploring High Growth Tech Stocks in the US Market
ARS Pharmaceuticals, Inc., a biopharmaceutical company, has received FDA approval for its innovative product, neffy 1 mg, an epinephrine nasal spray designed for children with severe allergies. This approval marks a significant milestone for the company, diversifying its product line and enhancing its competitive position in the allergy treatment market. Neffy’s needle-free design addresses a critical need for a user-friendly alternative to traditional injectable methods. The products inclusion in national formularies, such as those of Cigna Healthcare and Navitus Health Systems, significantly broadens its potential user base. Supported by robust clinical trials, neffy is poised to be a pivotal addition to ARS’s offerings, aligning with its strategy to innovate within the tech-driven pharmaceutical landscape.
FDA approved/pending approvalCustomersProduct Stage
growth-positive
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
UroGen Pharma Ltd., a biotech company focused on urothelial and specialty cancers, announced the grant of inducement restricted stock units (RSUs) to seven new employees. These employees will aid in the commercialization of Jelmyto®, UroGens first approved product, and the development of its pipeline. The RSUs, part of UroGens 2019 Inducement Plan, will vest over three years, contingent on continued employment. UroGen is known for its RTGel® technology, which enhances drug exposure in the urinary tract. The company is headquartered in Princeton, New Jersey, with operations in Israel.
Expand
growth-positive
UroGen Pharma to Report Fourth Quarter and Full-Year 2024 Financial Results on Monday, March 10, 2025
UroGen Pharma Ltd., a biotech company focused on developing treatments for urothelial and specialty cancers, announced it will report its fourth quarter and full-year 2024 financial results on March 10, 2025. The announcement will be followed by a live webcast and conference call. UroGen is known for its proprietary RTGel® reverse-thermal hydrogel technology, which enhances the therapeutic profiles of existing drugs by enabling longer exposure of urinary tract tissues to medications. The company offers Jelmyto® for pyelocaliceal solution and is investigating UGN-102 for intravesical solution, both aimed at non-surgical tumor ablation. UroGen is headquartered in Princeton, NJ, with operations in Israel.
growth-positive
Is UroGen Pharma Ltd. (URGN) the Best Small-Cap Growth Stock to Buy Now?
The article discusses the potential of small-cap stocks, specifically UroGen Pharma Ltd., as attractive investment opportunities due to their ability to deliver higher earnings growth compared to large-cap stocks. Nick Sheridan from Janus Henderson highlights the challenges small caps face in gaining visibility amidst the dominance of mega-cap tech stocks. However, with expected decreases in interest rates, small caps are poised to benefit, offering diversification and exposure to structural trends like de-globalization. Despite being under-researched and undervalued, small caps present opportunities for investors willing to conduct thorough research. The article emphasizes the persistent merger and acquisition activity involving small-cap targets, supporting the case for investing in them.
UroGen Pharma to Present at TD Cowen 45th Annual Health Care Conference
growth-positive
UroGen acquires IconOVir’s oncolytic virus assets
UroGen Pharma has expanded its oncology pipeline by acquiring assets related to the oncolytic virus ICVB-1042 from IconOVir Bio. The acquisition involves issuing $4 million in ordinary shares and a potential $15 million cash payment upon reaching sales milestones. UroGen will also pay royalties on net sales of ICVB products. This acquisition aligns with UroGens strategy to advance its uro-oncology pipeline and develop novel cancer therapies. The company is also exploring research partnerships to enhance its RTGel technology, which aims to improve the efficacy of immunotherapies. UroGen, headquartered in the US and operating in Israel, recently received FDA NDA acceptance for UGN-102 to treat bladder cancer.
AcquisitionPartners
growth-positive
UroGen Advances Long-Term Growth Strategy by Acquiring a Next-Generation Investigational Oncolytic Virus (ICVB-1042) and Announces Multiple Strategic Research Collaborations
UroGen Pharma Ltd., a biotech company specializing in urothelial and specialty cancers, has expanded its oncology pipeline by acquiring assets related to the oncolytic virus ICVB-1042 from IconOVir Bio, Inc. This acquisition is part of UroGens strategy to develop novel therapies for bladder and other specialty cancers. Additionally, UroGen has entered into strategic research collaborations to explore the potential of its RTGel technology in enhancing the effectiveness of immunotherapies. The company aims to advance its uro-oncology pipeline and drive innovation in cancer treatment, marking a significant milestone in its growth strategy.
AcquisitionPartners
growth-positive
UroGen Announces Results from Subgroup Analyses of the Pivotal ENVISION Trial Evaluating Impact of Baseline Tumor Burden and Focality on Response to UGN-102
UroGen Pharma Ltd. presented promising results from the ENVISION study at the ASCO GU 2025 symposium, showcasing the efficacy of UGN-102 in treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The study demonstrated high complete response (CR) rates across various subgroups, with 82.8% CR for patients with tumor burden ≤3 cm and 73.2% for those with larger tumors. The treatment maintained its effectiveness over 12 months, indicating UGN-102s potential as a durable treatment option. The study involved 240 patients, with 95% completing the treatment regimen. These findings highlight UGN-102s potential to become a significant therapeutic option for LG-IR-NMIBC.
Product Stage
growth-positive
Data from a Long-Term Follow-up Study to the OLYMPUS Trial that Shows a Median Duration of Response of Nearly Four Years in Patients Achieving Complete Response with JELMYTO Published in The Journal of Urology
UroGen Pharma Ltd. announced positive results from a long-term follow-up study of JELMYTO, an FDA-approved treatment for low-grade upper tract urothelial cancer (LG-UTUC). The study, published in The Journal of Urology, showed a median duration of response of 47.8 months among patients who achieved a complete response after primary chemoablation with JELMYTO. These findings underscore the treatments potential for sustained disease control. The company is also enrolling participants in the JELMYTO uTRACT Registry to collect real-world usage data. The studys positive results are expected to reinforce JELMYTOs value as a treatment option for LG-UTUC.
Product Stage
UroGen Pharma to Present at Upcoming Investor Conferences
growth-positive
New Real-World Durability of Response Data for JELMYTO Reports 68% Recurrence-Free Survival Rate (RFS) at Three Years Across a Broad Patient Population with Low-Grade Upper Tract Urothelial Cancer (LG-UTUC)
UroGen Pharma Ltd. has released promising results from a long-term study on JELMYTO, a treatment for low-grade upper tract urothelial cancer. The study, involving 56 patients, demonstrated a 68% recurrence-free survival rate at three years, regardless of tumor size, location, or administration route. Maintenance therapy was linked to higher recurrence-free survival, though further research is needed. These findings highlight JELMYTOs potential in providing long-term disease control, supporting its broad applicability and reinforcing UroGens commitment to advancing therapies for complex urological conditions.
growth-positive
ENVISION Trial Results Published in the February Issue of The Journal of Urology Highlight UGN-102 Achievement of 82.3% Duration of Response at 12 Months Paving the Way for the Potential First FDA-Approved Treatment for LG-IR-NMIBC in June 2025
UroGen Pharma Ltd. announced positive results from its Phase 3 ENVISION study of the investigational drug UGN-102 for treating low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). The study reported a 79.6% complete response rate at three months and an 82.3% duration of response at 12 months. These results highlight UGN-102s potential as a non-surgical treatment option, offering durable responses and potentially reducing recurrence rates for patients, particularly the elderly, who face repeated surgeries. The findings, published in The Journal of Urology, suggest that UGN-102 could significantly advance the management of LG-IR-NMIBC if approved.
Product Stage
growth-positive
Breakeven On The Horizon For UroGen Pharma Ltd. (NASDAQ:URGN)
UroGen Pharma Ltd., a biotechnology company specializing in urothelial and specialty cancers, is projected to reach profitability by 2026 according to industry analysts. Despite a current market cap of $454 million and significant losses in recent years, analysts expect the company to achieve a 67% annual growth rate to meet its breakeven target. However, the companys high debt-to-equity ratio poses a risk, necessitating careful capital management. The article emphasizes the importance of understanding UroGen Pharmas financial fundamentals and growth potential, while also highlighting the need for further research into its valuation and management team.
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
growth-positive
UGN-102 Showed Promising Long-Term Results in the Phase 3 ENVISION Trial, Potentially Paving the Way for First FDA-Approved Treatment for LG-IR-NMIBC
UroGen Pharma Ltd. announced promising results from its Phase 3 ENVISION trial for UGN-102, a treatment for recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). The trial demonstrated an 82.3% duration of response at 12 months and a 79.6% complete response rate at 3 months. These results, presented at the Society of Urologic Oncology annual meeting, suggest UGN-102 as a viable treatment option, addressing a significant unmet need for patients with recurrent low-grade bladder cancer. The safety profile was consistent with previous trials, and the company has secured a PDUFA goal date of June 13, 2025, from the FDA. This development is seen as a positive step towards improving patient outcomes by reducing the need for multiple surgeries.
growth-positive
Long-Term Follow-up Study to the OLYMPUS Trial Presented at SUO 2024 Reports Median Duration of Response of Four Years in Patients Who Achieved a Complete Response with JELMYTO®
UroGen Pharma Ltd. has released favorable long-term data for JELMYTO, a treatment for low-grade upper tract urothelial cancer (LG-UTUC). The data, presented at the Society for Urologic Oncology annual meeting and published in the Journal of Urology, shows a median duration of response of 47.8 months among patients who achieved a complete response in the OLYMPUS trial. This suggests that JELMYTO provides robust long-term control of LG-UTUC, potentially improving patients quality of life by reducing the need for invasive treatments. The study highlights JELMYTOs efficacy as a primary treatment option, although it notes limitations such as post-hoc analysis and selection bias.
growth-positive
UroGen Announces New Data Presentations at the Society of Urologic Oncology 2024 Annual Meeting Highlighting Urothelial Cancer Portfolio Aimed at Addressing Unmet Needs
UroGen Pharma Ltd., a biotech company focused on developing treatments for urothelial and specialty cancers, announced that new data on its products UGN-102, JELMYTO, and UGN-301 will be presented at the Society of Urologic Oncology (SUO) 2024 annual meeting in Dallas, Texas. The presentations will highlight the potential of UGN-102 for treating low-grade, intermediate-risk non-muscle-invasive bladder cancer and the ongoing clinical value of JELMYTO for low-grade upper tract urothelial carcinoma. The company emphasizes its commitment to addressing unmet needs in urothelial cancer treatment and improving patient outcomes and quality of life. The event will take place from December 4 to 6, 2024.
growth-positive
Wall Street Analysts Believe Urogen Pharma (URGN) Could Rally 209.92%: Here's is How to Trade
Urogen Pharma (URGN) has seen a 4.1% increase in its stock price over the past four weeks, closing at $12.70. Wall Street analysts have set a mean price target of $39.36, indicating a potential upside of 209.9%. The price targets range from $18 to $64, with a standard deviation of $15.76, suggesting variability in analyst opinions. Despite skepticism about the reliability of price targets, a strong consensus among analysts about Urogen Pharmas potential for better-than-expected earnings supports a positive outlook. The article highlights the potential for growth in Urogen Pharmas stock, driven by analyst agreement and positive earnings estimate revisions.
growth-positive
UroGen reports long-term data from study of JELMYTO for LG-UTUC treatment
UroGen Pharma has reported positive outcomes from a long-term follow-up study of JELMYTO (mitomycin) for treating low-grade, upper tract urothelial cancer (LG-UTUC) in adults. Among 71 subjects, 41 achieved a complete response with a median duration of 47.8 months. The study, despite some limitations, shows promising long-term durability of JELMYTO as a primary treatment. The JELMYTO uTRACT Registry is enrolling subjects to gather real-world data. UroGen Pharmas chief medical officer, Mark Schoenberg, emphasized the importance of managing relapse and preserving organ function in LG-UTUC treatment. The company is also conducting a Phase III trial for UGN-103 to treat low-grade intermediate-risk non-muscle invasive bladder cancer.
growth-positive
New Data from a Long-Term Follow-up Study to the OLYMPUS Trial Show Median Duration of Response of Four Years in Patients Who Achieved a Complete Response with JELMYTO®
UroGen Pharma Ltd. has published results from a long-term follow-up study of JELMYTO, an FDA-approved treatment for low-grade upper tract urothelial cancer (LG-UTUC). The study, published in the Journal of Urology, highlights a median duration of response of 47.8 months among patients who achieved a complete response after primary chemoablation with JELMYTO. This evidence suggests robust durability in maintaining control of LG-UTUC over an extended period. The studys findings are encouraging for the use of JELMYTO as a primary treatment, with ongoing research in the JELMYTO uTRACT Registry to gather real-world data. The studys limitations include its post-hoc nature and selection bias.
growth-positive
UroGen Pharma Ltd. (NASDAQ:URGN) Just Reported, And Analysts Assigned A US$39.93 Price Target
UroGen Pharma Ltd. recently released its quarterly results, showcasing strong performance with revenues of US$25 million, surpassing estimates by 4.1%. The companys losses per share were also better than expected, at US$0.55. Analysts have adjusted their forecasts, predicting a 49% revenue increase to US$133.4 million by 2025, with losses narrowing to US$2.46 per share. Despite a dip in revenue estimates, analysts are optimistic about reduced losses. The consensus price target fell by 7.4% to US$39.93, reflecting mixed sentiments. However, UroGen Pharma is expected to grow faster than its industry peers, with a 38% annualized revenue growth forecasted, compared to the industrys 21%.
growth-positive
UroGen Pharma Ltd (URGN) Q3 2024 Earnings Call Highlights: Revenue Growth and Strategic ...
UroGen Pharma Ltd reported a 21% year-over-year increase in net product revenue for Q3 2024, driven by strong patient demand. The company submitted a new drug application for UGN 102, which, if approved, will be the first FDA-approved treatment for low-grade intermediate-risk non-muscle invasive bladder cancer. This represents a significant market opportunity with over 80,000 addressable patients annually in the US, translating to a market of over $5 billion. Despite facing challenges with gross-to-net discounting and ongoing litigation related to intellectual property, UroGen remains optimistic about its robust pipeline and life cycle management strategy. The FDA has set a PDUFA target date of June 13, 2025, for UGN 102. The company expects full-year gel Mito revenues to fall below previous guidance due to these challenges.
Customers
growth-negative
Urogen Pharma (URGN) Reports Q3 Loss, Tops Revenue Estimates
Urogen Pharma reported a quarterly loss of $0.55 per share, which was better than the Zacks Consensus Estimate of a $0.84 loss, marking an earnings surprise of 34.52%. The company also reported revenues of $25.2 million, surpassing the consensus estimate by 4.06%. Despite these positive surprises, Urogen Pharmas stock has underperformed the market, losing about 18.6% since the beginning of the year compared to the S&P 500s gain of 21.2%. The companys earnings outlook remains unfavorable, with a Zacks Rank of #4 (Sell), indicating expected underperformance in the near future. Investors are advised to monitor earnings estimate revisions closely as they can significantly impact stock movements.
growth-positive
UroGen Pharma Reports 2024 Third Quarter Financial Results and Business Highlights, Including the Potential Launch of UGN-102 in 2025
UroGen Pharma Ltd. announced that the FDA has accepted its New Drug Application for UGN-102, a treatment for low-grade intermediate-risk non-muscle invasive bladder cancer. The company anticipates a potential FDA approval by June 13, 2025. UGN-102 has shown promising results in clinical trials, with a high complete response rate and duration of response. UroGen reported net product sales of $25.2 million for JELMYTO® in Q3 2024, an increase from the previous year. The company holds $254.2 million in cash and equivalents as of September 30, 2024. UroGen is preparing for a commercial launch of UGN-102, which could address a market opportunity exceeding $5 billion.
UroGen Pharma to Present at the Guggenheim Securities Healthcare Innovation Conference
UroGen Pharma to Report Third Quarter Financial Results on Wednesday, November 6, 2024
growth-positive
ENVISION Trial Results Published in the Journal of Urology Report 82.3% Duration of Response 12 Months after Achieving Complete Response for UGN-102, Potentially First FDA-Approved Non-Surgical Treatment for LG-IR-NMIBC
UroGen Pharma Ltd. announced promising results from the Phase 3 ENVISION study of their investigational drug UGN-102 for treating low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). The study demonstrated an 82.3% 12-month duration of response (DOR) for patients who achieved a complete response at three months. The drug showed a 79.6% complete response rate at three months, indicating its potential as a valuable treatment option. UroGen has submitted a New Drug Application (NDA) to the FDA, with a PDUFA goal date set for June 13, 2025. The results highlight UGN-102s potential to improve patient outcomes by reducing the need for repeated surgeries, which are common in treating LG-IR-NMIBC.
growth-negative
Investors in UroGen Pharma (NASDAQ:URGN) have unfortunately lost 42% over the last five years
The article discusses the performance of UroGen Pharma Ltd. over the past five years, highlighting a 42% decline in share price. Despite a 50% annual increase in revenue, shareholders have experienced a 7% annual loss over the same period. The companys stock has underperformed compared to the market average, although it has seen a 7.1% increase in the past year. The article suggests that the business may be stabilizing, but emphasizes the importance of considering other factors, such as risks, when evaluating the companys financial health.
growth-positive
FDA accepts UroGen’s UGN-102 NDA for bladder cancer treatment
UroGen Pharma has received acceptance from the US FDA for its new drug application (NDA) for UGN-102, a treatment for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The drug, which uses UroGens RTGel technology, is designed to prolong exposure of bladder tissue to mitomycin, offering a non-surgical treatment option. The NDA is supported by data from the Phase III ENVISION study, which showed a 79.6% complete response rate three months after the first instillation and an 82.3% 12-month duration of response. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of June 13, 2025, for a decision on the NDA. This development is seen as a pivotal moment for UroGen Pharma, potentially expanding treatment options for bladder cancer.
UroGen Announces FDA Acceptance of its New Drug Application for UGN-102
UroGen Appoints Chris Degnan as Chief Financial Officer
growth-positive
UroGen Pharma Ltd (URGN) Q2 2024 Earnings Call Highlights: Strategic Advances Amid Financial ...
UroGen Pharma Ltd reported its financial results for Q2 2024, highlighting a net product revenue of $21.8 million for JELMYTO, marking a 16% sequential growth. Despite a net loss of $33.4 million, the company successfully raised approximately $116.2 million through a public offering. UroGen is preparing for the NDA submission of UGN-102, with a potential FDA approval decision in early 2025. The company faces challenges with JELMYTOs revenue growth due to headwinds and increased expenses. However, the positive data from the ENVISION study for UGN-102 and the significant market opportunity estimated at over $5 billion are promising. UroGen plans to expand its sales force by adding 10 to 15 sales reps to support UGN-102s launch.
Public TradingExpand
growth-positive
UroGen begins subject dosing in Phase III bladder cancer drug trial
UroGen Pharma has commenced the Phase III UTOPIA clinical trial for its investigational drug UGN-103, aimed at treating low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The trial will enroll 87 subjects, each receiving a 75mg dose of UGN-103 weekly for six weeks. The efficacy will be evaluated based on the complete response rate at the three-month mark. UGN-103 utilizes UroGens RTGel platform technology, enhancing therapeutic profiles through sustained release. The FDA accepted the investigational new drug application for UGN-103 in April, allowing its use in adults with LG-IR-NMIBC. UroGens CEO, Liz Barrett, emphasized the significance of this milestone in advancing patient care. The trials initiation marks a positive step in the companys innovative treatment development.
First Patient Dosed in Phase 3 Clinical Trial of UGN-103, a Next Generation Mitomycin-Based Formulation in Development for the Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
growth-positive
UroGen Pharma (URGN): Short Seller Sentiment is Bearish On This ADR Stock
UroGen Pharma, an Israeli biopharmaceutical company listed on NASDAQ, is focused on developing non-surgical treatments for uro-oncology diseases, particularly bladder cancer. Despite being ranked as one of the worst ADR stocks to buy according to short sellers, the company has shown promising clinical outcomes with its products like JELMYTO and UGN-102. UGN-102 is currently under FDA submission and targets a $5 billion market. The company has attracted investment from 25 hedge funds, with Adage Capital Management being the largest shareholder. Analysts maintain a consensus Buy rating for the stock, with significant upside potential.
Investment
growth-positive
UroGen Pharma (URGN): Among the Worst Middle East and Africa Stocks to Buy Now
UroGen Pharma (NASDAQ:URGN), an Israeli biopharmaceutical company, is noted for its innovative treatments for urothelial and specialty cancers. The company has developed RTGel, a reverse-thermal hydrogel, and JELMYTO, which has shown a 58% complete response rate for low-grade upper tract urothelial cancer. UGN-102, targeting a $5 billion market for low-grade intermediate-risk non-muscle invasive bladder cancer, is under FDA review with potential approval in Q1 2025. Despite 16.87% of shares being shorted, 25 hedge funds, including Adage Capital Management, hold a bullish sentiment with stakes worth $329.33 million. The article ranks URGN as the 3rd worst Middle East and Africa stock to buy according to short sellers.
Investment
UroGen Receives New U.S. Patent Allowance for Next-Generation Mitomycin-Based Products Expected to Provide Protection Until December 2041
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
UroGen Pharma to Present at Upcoming Investor Conferences
growth-negative
UroGen Pharma Ltd. (NASDAQ:URGN) Released Earnings Last Week And Analysts Lifted Their Price Target To US$43.88
UroGen Pharma Ltd. has released its Q2 report, revealing revenues of $22m, below expectations, and a larger than forecast loss per share of $0.91. Analysts have adjusted their forecasts for the company, predicting revenues of $94.2m in 2024, an 11% improvement on the last 12 months. However, per-share losses are expected to increase to $3.49. Despite this, analysts have increased their price target for the company by 15% to $43.88. The companys revenue growth is expected to slow, but remain in line with the industry average.
Investment
UroGen Submits Completed UGN-102 NDA Seeking Approval as the First FDA-Approved Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
growth-negative
Urogen Pharma (URGN) Reports Q2 Loss, Misses Revenue Estimates
Urogen Pharma reported a quarterly loss of $0.91 per share, which is worse than the Zacks Consensus Estimate of a loss of $0.82. This is also a larger loss compared to $1.03 per share a year ago. The companys revenues for the quarter ended June 2024 were $21.85 million, missing the Zacks Consensus Estimate by 7.76%. This is slightly higher compared to year-ago revenues of $21.14 million. Urogen Pharmas shares have lost about 3.3% since the beginning of the year. The companys future performance will depend on managements commentary on the earnings call.
Investment
UroGen Pharma Ahead of Schedule to Complete UGN-102 NDA Submission and Reports 2024 Second Quarter Financial Results and Business Highlights
growth-negative
Earnings Preview: Precigen, Inc. (PGEN) Q2 Earnings Expected to Decline
Precigen, Inc. is expected to report a year-over-year decline in earnings and lower revenues for the quarter ended June 2024. The earnings report might impact the companys stock price depending on whether the key numbers are better or worse than expectations. The company is expected to post a quarterly loss of $0.09 per share, representing a year-over-year change of -12.5%. Revenues are expected to be $1.28 million, down 27.7% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 12.5% lower over the last 30 days.
InvestmentManagement Changes
UroGen Pharma to Report Second Quarter 2024 Financial Results on Tuesday, August 13, 2024
growth-positive
Does Urogen Pharma (URGN) Have the Potential to Rally 171.05% as Wall Street Analysts Expect?
Shares of Urogen Pharma (URGN) have seen a 5.4% increase over the past four weeks, closing the last trading session at $15.82. However, Wall Street analysts predict a potential upside of 171.1%, with a mean estimate of $42.88. This estimate comprises four short-term price targets ranging from $18 to $60. Analysts also agree that the company will report better earnings than previously estimated. Despite the potential for misleading investors, price targets are still highly sought after. URGN currently has a Zacks Rank #2 (Buy), indicating potential for further growth.
Investment
growth-positive
Urogen Pharma (URGN) Expected to Beat Earnings Estimates: Should You Buy?
Urogen Pharma is expected to post a year-over-year increase in earnings on higher revenues for the quarter ended June 2024. The companys earnings report could potentially impact its near-term stock price. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. The companys Earnings ESP is +4.66%, indicating that Urogen Pharma will most likely beat the consensus EPS estimate. However, investors are advised to pay attention to other factors too before making investment decisions.
Investment
growth-positive
Wall Street Analysts See a 149.01% Upside in Urogen Pharma (URGN): Can the Stock Really Move This High?
Urogen Pharmas stock closed at $17.22 in the last trading session, marking a 2.1% gain over the past four weeks. Wall Street analysts have set short-term price targets for the stock, with a mean price target of $42.88, indicating a 149% upside potential. The targets range from $18 to $60. Analysts also predict the company will report better earnings than previously estimated. However, the article cautions against relying solely on these targets for investment decisions, as they can often be misleading. Urogen Pharma currently has a Zacks Rank #2 (Buy), indicating potential upside in the near term.
Public Trading
UroGen Pharma Stock Earns 91 RS Rating
UroGen Pharma Announces Pricing of Public Offering of Ordinary Shares and Pre-Funded Warrants
UroGen Pharma Announces Pricing of Public Offering of Ordinary Shares and Pre-Funded Warrants
growth-positive
Urogen Pharma (URGN) Surges 9.7%: Is This an Indication of Further Gains?
Urogen Pharmas shares rose by 9.7% in the last trading session, closing at $19.20. This increase was supported by a higher than usual volume of shares being traded. The company recently announced data from the phase III ENVISION study, which is evaluating UGN-102 as a potential non-surgical treatment for patients with low-grade intermediate-risk non-muscle invasive bladder cancer. The data showed an 82.3% 12-month duration of response in patients who achieved complete response at three months after the first instillation of UGN-102.
Investment
growth-positive
UroGen Pharma Announces Commencement of Public Offering of Ordinary Shares and Pre-Funded Warrants
UroGen Pharma Ltd. has announced the commencement of an underwritten public offering to issue and sell its ordinary shares and pre-funded warrants. The biotech company, which focuses on developing and commercializing solutions for urothelial and specialty cancers, will also grant underwriters a 30-day option to purchase up to an additional 15% of the total number of ordinary shares offered in the public offering. The offering is subject to market and other conditions, and there is no assurance as to when or if the offering will be completed.
Public TradingInvestment
UroGen Announces Unprecedented 82.3% Duration of Response at 12 Months in the ENVISION Trial Investigating UGN-102 as Potentially the First FDA-Approved Non-Surgical Treatment for LG-IR-NMIBC
growth-positive
UroGen Catapults On 'Unprecedented' Results For Gel-Based Cancer Drug
UroGens stock value increased significantly due to unprecedented test results for its bladder cancer treatment. The drug, which is gel-based, provides an alternative to surgery.
Investment
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
UroGen Pharma to Host UGN-102 Virtual Data Event on June 13, 2024
UroGen Pharma to Present at the 45th Annual Goldman Sachs Global Healthcare Conference
UroGen Pharma Appoints David Lin as New Chief Commercial Officer
UroGen Pharma to Present at the TD Cowen 5th Annual Oncology Innovation Summit
Growth-Negative
UroGen Pharma First Quarter 2024 Earnings: Misses Expectations
UroGen Pharma reported its Q1 2024 results, with revenue of $18.8m, up 9.2% from Q1 2023, and a net loss of $32.3m, a widening of 6.9% from Q1 2023. However, the companys revenue and earnings per share (EPS) missed analyst estimates by 12% and 9.3% respectively. Looking ahead, the companys revenue is forecast to grow 35% p.a. on average over the next three years, compared to an 18% growth forecast for the US biotech industry. The companys shares are down 5.6% from a week ago.
Customers
UroGen Pharma Announces Date for ENVISION Data, New Long-Term Jelmyto Durability Data, and Reports 2024 First Quarter Financial Results and Business Highlights
Growth-Negative
UroGen Pharma Ltd (URGN) Q1 2024 Earnings: Misses EPS Estimates, Revenue Slightly Above Expectations
UroGen Pharma Ltd reported Q1 2024 revenue of $18.8 million, up from $17.2 million in Q1 2023, but fell short of the estimated $21.38 million. The net loss increased to $32.3 million from $30.2 million, exceeding the estimated net loss of $30.26 million. R&D expenses rose to $15.5 million from $12.5 million, reflecting ongoing investment in product development. The company reiterated full-year revenue guidance for JELMYTO between $95 million and $102 million. UroGen is preparing for the potential launch of UGN-102, targeting a market opportunity exceeding $3 billion.
Investment
Growth-Negative
Shareholders in UroGen Pharma (NASDAQ:URGN) have lost 67%, as stock drops 11% this past week
UroGen Pharma Ltd.s share price has dropped 67% in the last five years, with a 34% drop in the last three months alone. Despite this, the company has seen its revenue grow at 58% per year over the same period, a rate well above most other pre-profit companies. However, the share price has averaged a loss of 11% per year. Despite a total return of 5.7% during the last year, this falls short of the market average. The company is not currently profitable.
Customers
UroGen Pharma to Participate at Upcoming Investor Conferences
New Real-World Retrospective Analysis Presented at AUA 2024 Reports 86% Recurrence-Free Survival (RFS) at 24 Months with JELMYTO® Across All Studied Patient and Disease Characteristics in Cohort of Responders to Induction Therapy
New Real-World Study on Retrograde Instillation of JELMYTO® for Treatment of Low-Grade Upper Tract Urothelial Cancer Reports Similar Complete Response Rate and Lower Stricture Rate Compared to OLYMPUS Pivotal Trial
UroGen Announces Results from ATLAS Showing Robust UGN-102 Durability of Response in New and Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer at AUA 2024
UroGen Pharma to Report 2024 First Quarter Financial Results on Monday, May 13, 2024
growth-positive
Pharming Group (PHAR) Surges 7.2%: Is This an Indication of Further Gains?
Pharming Group N.V. Sponsored ADRs shares rose by 7.2% at the end of the last trading session, a significant increase compared to the stocks 15.2% loss over the past four weeks. This rise is attributed to positive investor expectations for the companys approved products in the upcoming Q1 2024 earnings release. The company is also expanding the eligible patient population for its product, Joenja. The company is expected to post quarterly earnings of $0.01 per share, a year-over-year change of +105.9%, and revenues of $68.43 million, up 60.9% from the year-ago quarter.
CustomersExpand
UroGen Announces New Data Presentations at the American Urological Association 2024 Annual Meeting Highlighting Clinical Benefits of Our Portfolio for Urothelial Cancers
UroGen Announces FDA Acceptance of Investigational New Drug Application for UGN-103, a Next Generation Mitomycin-Based Formulation for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
growth-positive
UroGen Pharma Ltd.'s (NASDAQ:URGN) high institutional ownership speaks for itself as stock continues to impress, up 11% over last week
Institutions hold a significant stake in UroGen Pharma, with the top 9 shareholders owning 50% of the company. This has a substantial influence on the companys share price. Recently, the companys stock price gained 11%, benefiting these institutional investors. However, insiders have been selling lately. The largest shareholder is RA Capital Management, L.P. with 9.0% of shares, followed by Great Point Partners, LLC and Menora Mivtachim Pensions & Gemel Ltd. The companys CEO, Elizabeth Barrett, directly holds 1.0% of the total shares. Private equity firms hold a 17% stake in UroGen Pharma.
Investment
UroGen Pharma Files Patent Infringement Action Against Teva Pharmaceuticals
Growth-Positive
UroGen Pharma Full Year 2023 Earnings: Revenues Beat Expectations, EPS In Line
UroGen Pharma has reported its full year 2023 results, with a revenue of US$82.7m, up 28% from FY 2022. The companys net loss narrowed by 6.9% to US$102.2m, and loss per share improved from US$4.81 in FY 2022 to US$3.55. The companys revenue exceeded analyst estimates by 1.2%, and its EPS was mostly in line with estimates. The companys shares are down 20% from a week ago. Looking ahead, revenue is forecast to grow 38% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US.
Customers
growth-positive
UroGen Pharma Ltd. (NASDAQ:URGN) Q4 2023 Earnings Call Transcript
UroGen Pharma Ltd. reported its Q4 2023 earnings, highlighting a successful year with progress and growth. The companys lead development candidate, UGN-102, met its primary endpoints in the Phase III ATLAS and ENVISION trials. UroGens existing commercial product, JELMYTO, continues to see double-digit growth. The company also announced an expanded partnership with Pharmakon Advisors, providing additional funding of up to $100 million. UroGen expects to have the capital to execute a comprehensive launch for UGN-102, if approved, and fund potential new clinical studies.
InvestmentExpand
growth-positive
UroGen Pharma Ltd (URGN) Reports Solid JELMYTO Growth Amidst Financial Challenges
UroGen Pharma Ltd reported a significant growth in its JELMYTO product revenues for Q4 2023, reaching $23.5 million, up from $18.1 million in the same period last year. The companys full year 2023 net revenues also increased to $82.7 million, a rise from $64.4 million in 2022. Despite this growth, the company faced challenges with higher than expected 340B chargebacks and estimated Medicare refunds for discarded drugs. The companys net loss narrowed to $26.0 million in Q4 2023, compared to a net loss of $28.9 million in Q4 2022. As of December 31, 2023, the companys liquidity position remains strong, with cash, cash equivalents, and marketable securities totaling $141.5 million.
CustomersInvestment
Growth-Negative
Urogen Pharma (URGN) Reports Q4 Loss, Tops Revenue Estimates
Urogen Pharma reported a quarterly loss of $0.72 per share, which is higher than the expected loss of $0.67 per share. However, the companys revenues for the quarter ending December 2023 were $23.53 million, surpassing the Zacks Consensus Estimate by 5.52%. This is an increase from the previous years revenues of $18.09 million. Despite the loss, Urogen Pharmas shares have increased by about 16.5% since the beginning of the year. The companys future performance will depend on managements commentary on the earnings call and the companys earnings outlook.
Investment
UroGen Pharma Delivers Double Digit JELMYTO® Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
UroGen Pharma to Report Fourth Quarter and Full-Year 2023 Financial Results on Thursday, March 14, 2024
UroGen Pharma to Present at TD Cowen 44th Annual Health Care Conference
growth-positive
Nurix Therapeutics, Inc. (NRIX) Surges 5.1%: Is This an Indication of Further Gains?
Shares of Nurix Therapeutics, Inc. (NRIX) rose by 5.1% in the last trading session, with a higher-than-average number of shares changing hands. This follows a 29.2% gain over the past four weeks. The rally is driven by growing optimism over the drug biotech sector in 2024. The company is expected to post a quarterly loss of $0.83 per share in its upcoming report, a year-over-year change of -10.7%. However, revenues are expected to be $14.28 million, up 12.5% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 2.2% higher over the last 30 days.
Investment
UroGen Pharma to Participate at Upcoming Investor Conferences
UroGen Initiates Submission of a Rolling NDA to the FDA for UGN-102
UroGen Secures Exclusive License from medac GmbH to Develop a Next-Generation Novel Mitomycin-Based Formulation for Urothelial Cancers
UroGen Pharma to Participate in the B. Riley Healthcare Conference
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
growth-positive
Shareholders in UroGen Pharma (NASDAQ:URGN) are in the red if they invested five years ago
UroGen Pharma Ltd.s share price has risen by 17% in the last month, however, it is still down by 73% over the last five years. Despite this, the company has seen its revenue grow by 62% per year over the same period. This growth is significantly higher than most other pre-profit companies. The recent increase in share price could indicate a positive turning point for the business, but potential investors are advised to look closely at the companys balance sheet strength.
Public Trading
growth-positive
UroGen Pharma Ltd. (NASDAQ:URGN) Q3 2023 Earnings Call Transcript
UroGen Pharma Ltd. held its Q3 2023 earnings call, reporting strong financial results and significant progress in its clinical trials. The company reported $20.9 million in JELMYTO net revenues, a 30% increase year-over-year. UroGen also closed a $120 million private placement during the quarter, significantly strengthening its balance sheet. The companys UGN-102, a potential treatment for low-grade intermediate-risk nonmuscle-invasive bladder cancer, showed promising results in Phase III clinical trials. If approved, UGN-102 could become a major growth driver for UroGen, with a potential market in the U.S. exceeding $3 billion.
CustomersInvestment
UroGen Pharma Reports Third Quarter 2023 Financial Results
growth-positive
UroGen Pharma Ltd (URGN) Reports Growth in Q3 Revenue and Progress in Clinical Trials
UroGen Pharma Ltd has reported a 29.8% increase in net product revenue from JELMYTO in Q3 2023 compared to Q3 2022. The companys net loss improved to $21.9 million in Q3 2023, down from $25.8 million in Q3 2022. UroGen also highlighted significant milestones in its clinical development, particularly the positive results from the ENVISION and ATLAS Phase 3 trials of UGN-102 for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer. The company reiterated its full-year 2023 guidance, expecting net product revenues from JELMYTO to be in the range of $76 to $86 million.
Customers
UroGen will Present Scientific Advances in Bladder Cancer at the Annual Meeting of the Society of Urologic Oncology
UroGen Pharma to Report Third Quarter 2023 Financial Results on Tuesday, November 14, 2023
Neutral
Institutional investors own a significant stake of 50% in UroGen Pharma Ltd. (NASDAQ:URGN)
Institutions hold a significant stake in UroGen Pharma Ltd., with the top 13 shareholders controlling 51% of the business. The largest shareholder is Menora Mivtachim Pensions & Gemel Ltd., owning 8.2% of the shares. The companys CEO, Elizabeth Barrett, owns 1.1% of the shares. Private equity firms hold a 13% stake in UroGen Pharma. The general public, primarily individual investors, hold a 30% stake in the company. The substantial institutional ownership suggests credibility among professional investors.
Investment
Following Pre-NDA Meeting with the FDA, UroGen Announces Rolling NDA Submission for UGN-102 to Begin January 2024
Growth-Positive
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
UroGen Pharma Ltd., a biotech company focused on urothelial and specialty cancers, has announced the grant of inducement restricted stock units (RSUs) to 11 new employees and options to one new employee. These new team members will support the commercial launch of Jelmyto, UroGens first approved product, and the continued development of the companys pipeline. The RSUs and options will vest equally over three years, subject to the employees continued service with UroGen. The companys sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, potentially making local therapy a more effective treatment option.
Expand
growth-positive
UroGen Pharma to Present at Upcoming Investor Conferences
UroGen Pharma Ltd. will be presenting at two investor conferences in September. The company is dedicated to developing and commercializing solutions for urothelial and specialty cancers. They have developed a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. UroGens products include JELMYTO® for pyelocalyceal solution and investigational treatment UGN-102 for intravesical solution for patients with low-grade non-muscle invasive bladder cancer. The investor conferences will be available via webcast on UroGens website.
InvestmentExpand
growth-positive
UroGen Pharma (URGN) Stock Surges 89% in a Month: Here's Why
UroGen Pharmas stock has surged 89.2% in the past month following positive data from two phase III studies evaluating UGN-102, a treatment for bladder cancer. The studies met their primary endpoints, showing the superiority of UGN-102 over the current standard of care. UroGen plans to file a new drug application with the FDA in 2024. If approved, UGN-102 will be the companys second marketed product. UroGen recently completed a private placement of shares and warrants to fund its operations.
Customers
growth-positive
New Treatment for Bladder Cancer Offers This Biotech a Second Chance
UroGen Pharma, a biotech company, is seeking investor interest after its first approved drug faced commercial challenges. The company recently announced positive results from trials of its reformulated chemotherapy drug for bladder cancer patients. The drug outperformed the standard treatment in a specific patient subset. UroGen Pharma plans to gather more data on the drugs durability of response and submit it for FDA approval next year.
CustomersInvestment
growth-positive
UroGen Pharma Ltd. (NASDAQ:URGN) Q2 2023 Earnings Call Transcript
UroGen Pharma Ltd. reported its Q2 2023 earnings, beating expectations with a reported EPS of $-1.03 against expectations of $-1.13. The company also announced positive results from two Phase 3 clinical trials for UGN-102, a treatment for low grade intermediate risk non-muscle invasive bladder cancer. UroGen also reported record net revenues of $21.1 million for JELMYTO, a 27% increase from the same quarter the previous year. The company recently raised $120 million in a private placement of ordinary shares.
InvestmentExpand
growth-positive
UroGen Pharma Reports Record JELMYTO Quarterly Sales and Recent Corporate Developments
UroGen Pharma Ltd. has announced positive results from its ENVISION and ATLAS Phase 3 trials of UGN-102 in treating low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). The company also reported record JELMYTO net product revenues in Q2 2023 of $21.1 million, a 27% increase from the same period last year. UroGen has also strengthened its balance sheet with a $120 million private placement of ordinary shares and pre-funded warrants. The company anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024.
InvestmentExpand
growth-positive
Urogen Pharma (URGN) Reports Q2 Loss, Tops Revenue Estimates
Urogen Pharma reported a quarterly loss of $1.03 per share, which is better than the Zacks Consensus Estimate of a loss of $1.13. This is also an improvement from a loss of $1.18 per share a year ago. The company posted revenues of $21.14 million for the quarter ended June 2023, surpassing the Zacks Consensus Estimate by 6.23%. This is an increase from year-ago revenues of $16.6 million. Urogen Pharma shares have added about 133.4% since the beginning of the year. The companys future performance will depend on managements commentary on the earnings call.
Investment
growth-positive
Wall Street Analysts Think Urogen Pharma (URGN) Could Surge 89.61%: Read This Before Placing a Bet
Shares of Urogen Pharma have increased by 115.6% over the past four weeks, closing the last trading session at $20.70. Wall Street analysts predict further growth, with a mean estimate of $39.25, indicating a potential upside of 89.6%. The company is also expected to report better earnings than previously estimated. However, the article warns against relying solely on these predictions for investment decisions, as they can often be misleading. Instead, it suggests considering other factors such as earnings estimate revisions and the companys Zacks Rank. Urogen Pharma currently has a Zacks Rank #2 (Buy), indicating potential for further growth.
Investment
growth-positive
The Journal of Urology Publishes Peer-Reviewed Article Highlighting UGN-102 Data in Non-Surgical Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
UroGen Pharma Ltd. has announced that The Journal of Urology has published data from the Phase 3 ATLAS trial for investigational agent UGN-102 (mitomycin) for intravesical solution in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The trial demonstrated superiority to transurethral resection of bladder tumor surgery (TURBT) with a 55% reduction of risk for recurrence, progression, or death in patients who received UGN-102. The company hopes that UGN-102 could provide an effective, non-surgical therapy option beyond TURBT for this large patient population. A New Drug Application (NDA) is anticipated to be submitted to the U.S. Food and Drug Administration (FDA) in 2024.
InvestmentExpand
Neutral
UroGen Pharma to Report Second Quarter 2023 Financial Results on Thursday, August 10, 2023
UroGen Pharma Ltd., a biotech company focused on developing and commercializing solutions for urothelial and specialty cancers, has announced that it will report its second quarter 2023 financial results on Thursday, August 10, 2023. The announcement will be followed by a live audio webcast and conference call. UroGen has developed a proprietary sustained release, hydrogel-based platform technology that aims to improve the therapeutic profiles of existing drugs. The companys first commercial product is Jelmyto, a solution for patients with low-grade non-muscle invasive bladder cancer.
Public Trading
growth-positive
‘Opportunities Outweigh Risks’: Oppenheimer Sees at Least 60% Gains in These 2 Stocks
Oppenheimers Chief Investment Strategist, John Stoltzfus, predicts a continued bull market, creating more opportunities for investors. Among Oppenheimers top picks are Enovix Corporation and UroGen Pharma. Enovix, a developer and manufacturer of high-capacity lithium-ion batteries, has exceeded production targets and secured $70 million in non-dilutive local funding from YBS International Berhad. UroGen Pharma, a biotech company, has seen success with its FDA-approved treatment, Jelmyto, and is planning to submit a marketing application for another treatment, UGN-102, next year.
InvestmentCustomers
Growth-Positive
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
UroGen Pharma Ltd., a biotech company focused on urothelial and specialty cancers, has announced the hiring of Michael Louie as SVP Medical Affairs & Clinical Development. As part of his employment package, Louie has been granted inducement restricted stock units (RSUs) and options. Up to 30,000 ordinary shares of UroGen are issuable upon the vesting and settlement of the RSUs and up to 20,000 ordinary shares are issuable upon the vesting and exercise of the Options. The RSUs and Options will vest over three years, subject to Louies continued service with UroGen.
Management Changes
growth-positive
Biotech Firm To Raise $120M After Promising Cancer Drug Trials
UroGen Pharma, an Israeli-founded biotech company, has announced plans to raise $120 million following positive results from clinical trials of its bladder cancer drug, UGN-102. The funding will come from investors including Capital, Green Point Ventures, Acorn Bioventures, Monograph Capital, and Horton Capital Partners Fund, LP. UGN-102 is designed for patients with bladder cancer that can be treated by surgery but has a high recurrence rate. The companys research found that 64.8% of patients with low-grade bladder cancer who were administered the drug had no detectable disease three months after starting treatment.
Investment
growth-positive
Why Shares of UroGen Pharma Jumped Friday
Shares of UroGen Pharma were up by over 25% following the announcement of positive top-line data from two phase 3 trials for UGN-102, a bladder cancer therapy. The intravesical solution is designed to treat patients with low-grade, intermediate-risk non-muscle-invasive bladder cancer.
Investment
growth-positive
UGN-102, in Development as the Potential First Non-Surgical Therapy for LG-IR-NMIBC, Met Primary Endpoints in Both Phase 3 ATLAS and ENVISION Clinical Trials
UroGen Pharma Ltd. has announced positive topline data from its Phase 3 trials ATLAS and ENVISION studying UGN-102 for intravesical solution in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). Both trials met their primary endpoints, with UGN-102 demonstrating a 55% reduction of risk for recurrence, progression, or death in the ATLAS trial and a 79.2% complete response rate at 3-months in the ENVISION trial. The company anticipates submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 2024.
Investment
growth-positive
UroGen Announces $120 Million Private Placement of Ordinary Shares
UroGen Pharma Ltd. has announced a definitive securities purchase agreement in connection with a private placement to selected institutional and accredited investors. The private placement was led by RA Capital Management L.P. and Great Point Partners LLC, and also included Acorn Bioventures, Monograph Capital, and Horton Capital Partners Fund, LP. UroGen expects to receive gross proceeds of approximately $120 million. The net proceeds will be used for non-clinical and clinical development activities for its product candidates, commercialization expense, and general corporate purposes. The private placement is expected to close on July 28, 2023.
Investment
growth-positive
UroGen Pharma Announces the Appointment of James Robinson to its Board of Directors
UroGen Pharma Ltd., a biotech company specializing in urothelial and specialty cancers, has announced the appointment of James Robinson to its Board of Directors. Robinson, the former President and CEO of Urovant Sciences, brings over 30 years of experience in the biopharmaceutical industry. His appointment is expected to provide valuable guidance as UroGen seeks to expand access to JELMYTO and advance its lead clinical development program, UGN-102, for low-grade intermediate risk bladder cancer. Robinsons background aligns well with the current Board members, and his leadership is anticipated to be beneficial for the company.
Management ChangesExpand
growth-positive
Retrospective Study Finds JELMYTO® Use Effective Following Partial Ablation or Biopsy in Larger Volume Low-Grade Upper Tract Urothelial Tumors that Impede Kidney Preservation
UroGen Pharma Ltd. has highlighted the results of a sub-analysis from the first post-commercial utilization review of JELMYTO for pyelocalyceal solution. The study assessed the efficacy of JELMYTO in managing patients with larger volume disease where initial tumor burden may not be amenable to complete mechanical ablation or renal preservation. The study found no significant differences in the rates of rendered disease free among those who underwent complete ablation, partial ablation, or biopsy only during the initial URS procedure. The findings provide evidence in support of a new treatment strategy utilizing JELMYTO for reducing the volume of larger low-grade tumors to help spare the kidney.
Customers
Retrospective Study Reveals Lower Stricture Rate and Comparable Oncological Outcomes with Antegrade Administration of JELMYTO® Versus Retrograde Administration
UroGen Pharma Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
UroGen Pharma to Present at Upcoming Investor Conferences
growth-positive
With 58% institutional ownership, UroGen Pharma Ltd. (NASDAQ:URGN) is a favorite amongst the big guns
The article discusses the ownership structure of UroGen Pharma Ltd. and the influence of institutional investors on the companys share price. Institutional investors hold a majority stake of 58% in the company, indicating their confidence in its future. The top 11 shareholders control 51% of the ownership, with no single shareholder having a majority interest. The largest shareholder is Menora Mivtachim Pensions & Gemel Ltd. The article also mentions the insider ownership, with insiders collectively owning US$27m worth of shares. The general public holds a 26% stake, while private equity firms hold a 6.3% stake. The article highlights the importance of considering other information and risks when analyzing the company. The event described in the article is ongoing and does not have a specific date.
Investment
growth-positive
UroGen Pharma Ltd. (NASDAQ:URGN) Q1 2023 Earnings Call Transcript
UroGen Pharma Ltd. reported its Q1 2023 earnings, beating expectations with a reported EPS of $-1.3 against expectations of $-1.33. The company reported net revenues of $17.2 million for the quarter, a 27% increase from the same quarter the previous year. The companys product JELMYTO continues to see growth in adoption. The company also highlighted its development strategy focus on UGN-102, with top line data from Phase III studies expected to be provided in the summer. The company also addressed its balance sheet, emphasizing fiscal prudence and prioritizing cash spend on advancing core value drivers.
CustomersManagement Changes
UroGen Pharma Meets Revenue Goal, Reports First Quarter 2023 Financial Results and Recent Corporate Developments
Urogen Pharma (URGN) Reports Q1 Loss, Tops Revenue Estimates
UroGen Pharma to Report 2023 First Quarter Financial Results on Thursday, May 11, 2023
Earnings Preview: Urogen Pharma (URGN) Q1 Earnings Expected to Decline
First Study to Evaluate JELMYTO® Use Post-Complete Endoscopic Ablation Reports 69% of Patients were Disease Free at the Time of First Endoscopic Evaluation
New Retrospective Study Presented at AUA 2023 Provides Evidence of Similar Outcomes Utilizing JELMYTO® in the Treatment of UTUC of the Ureter and Renal Pelvis
UroGen Pharma to Present at H.C. Wainwright BioConnect Conference
UroGen Pharma Ltd.'s (NASDAQ:URGN) Prospects Need A Boost To Lift Shares
growth-positive
UroGen Pharma Ltd. (NASDAQ:URGN) Q4 2022 Earnings Call Transcript
UroGen Pharma Ltd. reported its Q4 2022 earnings, highlighting a 34% increase in net product revenues from 2021, ending the year with $64.4 million. The companys product JELMYTO had its strongest quarter ever, and the company is optimistic about the potential of UGN-102, a non-surgical treatment for low-grade intermediate risk non-muscle invasive bladder cancer. UroGen expects to provide top line data from Phase 3 studies of UGN-102 midyear, and if results are positive, it plans to submit to the FDA in 2024. The company ended the year with $100 million in cash and expects revenue growth in 2023 to reflect growth of 20% to 30% over 2022.
CustomersInvestment
UroGen Pharma Reports Highest Revenue Quarter and Significant Full Year 2022 Growth and Recent Corporate Developments
Urogen Pharma (URGN) Reports Q4 Loss, Lags Revenue Estimates
UroGen Pharma to Report Fourth Quarter and Full-Year 2022 Financial Results on Thursday, March 16, 2023
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Axsome Therapeutics (AXSM) Reports Q4 Loss, Tops Revenue Estimates
Investigational Therapy UGN-102 May Be Delivered at Home for the Treatment of Bladder Cancer
UroGen Pharma Ltd. (NASDAQ:URGN) Is Expected To Breakeven In The Near Future
UroGen Pharma to Host Thought Leader Webinar on UGN-102 and Non-Muscle Invasive Bladder Cancers
FDA Authorizes an Extension of the In-Use Period for UroGen Pharma's JELMYTO® Admixture to 96 Hours Following Reconstitution
growth-positive
UroGen Pharma Appoints Dr. Leana S. Wen to Board of Directors | citybiz
UroGen Pharma has appointed Dr. Leana S. Wen to its Board of Directors. Dr. Wen is an emergency medicine physician and public health and policy expert. Her appointment is expected to bring a deep understanding of diverse stakeholders and the complex dynamics of the biopharmaceutical industry to UroGen. The company aims to transform the field of uro-oncology with therapeutic interventions. Dr. Wen has previously served on the board of directors of Glaukos Corporation and is a contributing columnist for The Washington Post. She has extensive experience in health policy and public health.
Management Changes
UroGen Pharma Reports Fourth Quarter and Full-year 2021 Financial Results and Recent Corporate Developments
UroGen Pharma Presents Data Showcasing Novel Clinical Data at 2021 American Urological Association (AUA) Annual Meeting
UroGen Pharma Announces License and Supply Agreement with Neopharm to Pursue Regulatory Approval and Commercialization for Jelmyto® in Israel
UroGen Pharma Announces $75 Million of Non-Dilutive Funding from RTW Investments
UroGen Pharma Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
growth-positive
"Exits are not a Strategy. I Never put up a 'For Sale' Sign"
The article features an interview with Arie Belldegrun, chairman of UroGen Pharma. The article discusses his experience with COVID-19, the progress of vaccine development, Israels handling of the pandemic, and UroGen Pharmas FDA approval for a gel that replaces kidney surgery. The company has raised $300 million through IPOs and is still being traded at a valuation of around $500 million. The article also mentions UroGen Pharmas major product for bladder cancer treatment, which is expected to receive FDA approval within a year. Belldegrun emphasizes that exits were never the strategy for UroGen Pharma, but if the company proves to be of interest to big companies, it would be a great outcome.
InvestmentPublic Trading
growth-positive
FDA approves UroGen's urothelial cancer drug
UroGen Pharma has received FDA acceptance for its New Drug Application (NDA) for UGN-101, a treatment for low-grade upper tract urothelial cancer. UGN-101 will be the only drug available for this type of cancer. The FDA has granted priority review for UGN-101, shortening the review period to six months. The company is on track for the potential launch of UGN-101 by mid-year 2020. UroGen Pharma has raised $320 million from investors including Mori Arkin, OurCrowd, Pontifax, and CHealth Fund.
Customers
growth-positive
Urogen buys new urinary tract cancer drug candidate
Urogen Pharma has acquired the rights to develop a delayed-release version of a new upper urinary tract cancer drug from Agenus. The acquisition aims to combine Agenuss product with Urogens unique technology for delayed release of drugs in the urinary tract. Urogens share price increased by 13.6% following the announcement, and its market cap reached $500 million. Agenuss share price also rose by 9.3%, increasing its market cap to $535 million. Urogen will pay $10 million immediately for the rights to develop the product, with an additional $115 million if Agenuss product meets certain milestones. Urogen will assume responsibility for the development and marketing of the product.
Acquisition
growth-negative
Prof. Arie Belldegrun sees $1b market for UroGen drugs
Israeli company UroGen Pharma announced the results of a trial for its second product in the treatment of bladder cancer. The trial showed that the product caused the malignant tumor to vanish in 63% of patients. UroGens leading product for the treatment of cancer in the upper urinary tract is scheduled to reach the market next year. The companys share price has dropped 36% in 2019. UroGens market cap is $682 million. The company is preparing for the launch of its leading product, including assembling a sales team and working on insurance reimbursement. UroGen aims to create a urology company and acquire rights to additional products in the future.
Customers
growth-positive
Johnson & Johnson Subsidiary Janssen Partners With Sustained Drug Release Company UroGen
UroGen Pharma Ltd. has announced a research agreement with Janssen Research & Development LLC. The two companies will collaborate on an early-stage feasibility evaluation in a therapeutic area of mutual interest. The financial terms of the agreement were not disclosed.
Partners
growth-positive
Cancer co Urogen to raise $150m in Nasdaq offering
Urogen Pharma plans to raise $150 million through a shelf prospectus on Nasdaq. The company recently appointed a new president and CEO, Liz Barrett, and published positive results for its urinary tract cancer treatment. The market responded positively to the announcement, with Urogens share price rising 5%. The funds raised will be used to launch the upper urinary tract cancer treatment and expedite clinical trials for other urinary cancer drugs. Urogens chairperson, Arie Belldegrun, has played a significant role in the companys growth. Urogen was founded in 2004 and had a successful IPO in 2017.
InvestmentManagement Changes
growth-positive
Urogen reports positive Phase III urinary tract cancer drug results
Israeli company Urogen Pharma expects FDA approval and plans to launch its drug this year. In a Phase III trial, 58% of patients responded fully to treatment, with no cancer found after treatment. The trial was conducted on 60 patients without a control group. Urogen submitted the results for FDA approval on a rolling submission track and expects approval in 2019. The company appointed Elizabeth Barrett as CEO, who has connections with Urogens chairperson and a background in the cancer sector. Urogens market cap before the trial results was $878 million. The companys product is a polymer that becomes a gel at body temperature, allowing for delayed drug release. Urogen plans to prepare production facilities before approval is granted.
CustomersInvestment
growth-positive
UroGen Pharma raises $60m in Nasdaq offering
UroGen Pharma, a drug delivery developer, has seen a 230% increase in its share price since its IPO in April 2017. The company recently raised $60 million in a secondary issue on Nasdaq, bringing its total raised amount to nearly $120 million. UroGen has developed a unique system for delivering drugs to the bladder and is also working on a Botox-based product for relieving overactive bladder syndrome in partnership with Allergan. The companys independent product is set to enter Phase IIb clinical trials in mid-2018. The successful financing round and planned IPOs by other medical companies indicate a positive start for the offerings market in 2018.
Public TradingPartners
growth-positive
UroGen Pharma raises $58.2m in Nasdaq IPO
UroGen Pharma, an Israeli urological cancer treatment developer, raised $58.2 million in its Nasdaq IPO, exceeding the planned amount by 20%. The company offered 4,473,373 shares at $13 per share, resulting in a valuation of $150 million. Jefferies LLC and Cowen and Company, LLC acted as joint book-running managers for the offering. UroGen Pharmas main shareholders include Arkin Holdings, Pontifax fund, ProQuest Investments, Telormedix, and Tatham Investments. The company is led by CEO Ron Bentsur and Chairman Prof. Arie Belldegrun. The offering is expected to close on or about May 9, 2017.
Public Trading
growth-positive
UroGen Pharma sets terms for $45m Nasdaq IPO
UroGen Pharma, an Israeli urological cancer treatment developer, plans to raise $45 million through an IPO on Nasdaq. The company will offer 3.5 million shares at a price range of $12 to $14, giving UroGen a valuation of $166 million. Insiders will purchase $20 million worth of shares in the offering. UroGen Pharma was founded in 2004 and has major shareholders including Arkin Holdings, Pontifax fund, ProQuest Investments, Telormedix, and Tatham Investments. The IPO is expected to take place on Thursday.
Public Trading
growth-positive
UroGen Pharma files for $50m Nasdaq IPO
UroGen Pharma, an Israeli urological cancer treatment developer, has filed for an IPO on Nasdaq to raise up to $50 million. The company, formerly known as TheraCoat, is focused on developing novel therapies for urological pathologies. Its lead drug candidates, MitoGel and VesiGel, aim to remove tumors non-surgically. UroGen Pharma also has an additional drug candidate, Vesimune, for the treatment of high-grade non-muscle invasive bladder cancer. The company has recently licensed BotuGel to Allergan for further development. UroGen Pharmas CEO is Ron Bentsur, and its chairman is Prof. Arie Belldegrun. The largest shareholder is Mori Arkins Arkin Holdings. Other shareholders include Pontifax fund, ProQuest Investments, Telormedix, and Tatham Investments.
Public Trading
growth-positive
Bladder treatment co TheraCoat raises $7m
TheraCoat Ltd. has raised $7 million from investors for R&D, clinical trials, and the launch of sales. The company has developed a unique platform technology for targeted drug delivery into internal cavities, including the bladder. TheraCoats system improves the therapeutic index of drugs, patient benefit, compliance, safety, and extends patent protection. They have received EU CE Mark and are preparing for clinical trials for urologic applications. The company aims to address non-muscle invasive bladder and urothelial cancer, and overactive bladder. The funds raised will support clinical trials and the marketing strategy of their lead product. TheraCoat plans to expand the development of their urological products.
InvestmentExpand
growth-positive
Theracoat gel makes drugs stick to the bladder
Theracoat, an Israeli company, has developed a new drug delivery system called Intra Cavity Drug Retention (ICDR) using a unique material that becomes a sticky gel once inside the body. The gel is currently undergoing advanced clinical trials in Europe and is classified as a medical device. The company aims to provide a new and better way for delivering drugs to any cavity in the body. Theracoats material has the potential to be used in various treatments, including bladder cancer, incontinence, and other malignancies. The company is seeking strategic partnerships with pharmaceutical companies and is currently testing its material in bladder cancer chemo in Europe and Israel. The solutions for bladder cancer and incontinence are expected to be ready in 2014.
Customers
UroGen Pharma Team
Employee Info
| Employees (range) | 201-500 |
| Exact count | 315 |
| Team members | 3 |
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Admin Info
| Confidence | 90/100 |
| Missing | video or image, markets, not claimed |
| BI Verification | Yanina Wainscheinker |
| Registrar ID | 513537621 |
| Crunchbase | urogen-pharma |
| Phone | +972774171410 |
| Creator | Rebecca Mack |
| Creator email | rebeccamack26@gmail.com |
| Last updater | Yanina Wainscheinker |
| Updater email | yanina.wainscheinker@sncentral.org |
| Last update | 2024-10-28T00:00:00.000Z |
| Created | 2014-07-27T00:00:00.000Z |
| Status detail | Public on NASDAQ on May, 2017<br> |