PRINCETON, N.J., Feb. 04, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that management will present at the Guggenheim Securities Emerging Outlook: Biotech Summit to take place on February 11-12, 2026. Guggenheim Emerging Outlook: Biotech Summit 2026 Date / Time:February 12, 2026, at 2:30 PM ETFormat:Fireside Chat and 1x1 investor meetingsLocation:New ...

Core Insights - UroGen Pharma Ltd. has announced improved access to ZUSDURI (mitomycin) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) due to the implementation of a permanent J Code (J9282) effective January 1, 2026, which is expected to streamline billing and reimbursement processes [1][3][2] Company Overview - UroGen Pharma is a biotech company focused on developing innovative solutions for urothelial and specialty cancers, utilizing proprietary RTGel technology for sustained drug release [6][4] - The company’s first product is approved for low-grade upper tract urothelial cancer, while ZUSDURI is specifically approved for recurrent LG-IR-NMIBC [6][4] Product Information - ZUSDURI is the first and only FDA-approved therapy for adults with recurrent LG-IR-NMIBC, providing a non-surgical chemoablative treatment option [2][4] - The drug is administered directly into the bladder using a urinary catheter in an outpatient setting, allowing for effective tumor treatment without surgery [4][6] Market Context - Approximately 82,000 individuals in the U.S. are diagnosed with NMIBC annually, with around 59,000 experiencing recurrence [5] - The median age of diagnosis for bladder cancer is 73 years, and up to 70% of NMIBC patients may face at least one recurrence, highlighting the need for effective treatment options [5]

Company Overview - Wildcat Capital Management sold all 495,606 shares of UroGen Pharma Ltd. (NASDAQ:URGN), marking a complete exit from the position valued at approximately $6.79 million [2][3][7] - UroGen Pharma's shares are currently priced at $23.52, reflecting a 113% increase over the past year, significantly outperforming the S&P 500, which rose about 15% in the same timeframe [4] - The company's market capitalization stands at $1.10 billion, with a trailing twelve months (TTM) revenue of $96.52 million and a TTM net income of -$164.64 million [5] Company Operations - UroGen Pharma specializes in developing and commercializing proprietary therapies for urothelial and specialty cancers, utilizing RTGel technology to enhance drug delivery [9][10] - The company targets healthcare providers treating patients with urothelial diseases, particularly focusing on non-muscle invasive bladder and upper tract cancers [10][11] - UroGen's product pipeline and commercial offerings position it as a differentiated player in the specialty pharmaceutical sector, addressing significant unmet medical needs in urothelial oncology [11] Investment Context - The liquidation of UroGen shares by Wildcat Capital is viewed as disciplined capital recycling rather than a lack of confidence, especially given the significant one-year price increase [12][13] - UroGen's commercial product, Jelmyto, remains a key asset, and the company continues to pursue large unmet needs in urothelial cancers [14]

UroGen Pharma FY Conference Summary Company Overview - UroGen Pharma focuses on delivering local medicine to the urothelium, addressing unmet needs in treating urothelial cancers with its innovative RT Gel technology, which transforms from liquid to gel at body temperature [6][7] Key Product: ZUSDURI - ZUSDURI is the first FDA-approved non-surgical option for intermediate-risk non-muscle-invasive bladder cancer (NMIBC) [8] - The product addresses a significant unmet need in treating low-grade, intermediate-risk NMIBC, which has a high recurrence rate [9][10] - Historical treatment involved TURBT procedures, which are invasive and not comprehensive [10][11] Commercial Launch Insights - The commercialization of ZUSDURI is complex, akin to a drug-device combination, requiring operational logistics and physician education [12][13] - The transition from patient enrollment to actual dosing can take up to 60 days, presenting a challenge in revenue recognition [15][17] - Initial sales figures indicated a slower start, but there is optimism about future growth as logistical hurdles are addressed [23][25] Reimbursement Dynamics - Revenue is recognized upon shipment, with a just-in-time inventory model [17][18] - The introduction of a permanent J-code in January is expected to enhance reimbursement confidence among physicians [19][21] - A service warranty is offered to assist physicians with reimbursement processes, although actual usage is anticipated to be low due to positive reimbursement experiences [20] Market Expectations - Approximately 70% of physicians are reportedly waiting for the J-code before using ZUSDURI [21] - Anticipated revenue growth post-J-code is expected to mirror previous experiences with similar products, with a projected 220% increase in revenue within six months [26][27] Competitive Landscape - The entry of competitors into the intermediate-risk space is viewed positively, as it can drive innovation and provide more options for patients [33][34] - UroGen's treatment offers a significant advantage with an 80% complete response rate without the need for surgery, compared to competitors that require surgical intervention [35] Future Developments - UGN-103 and UGN-104 are next-generation formulations with patent protection until 2041, aimed at replacing UGN-102 post-J-code [40][42] - The company is confident in its ability to transition from UGN-102 to UGN-103 without regulatory issues [48][50] Long-term Outlook - The company anticipates continued growth for Jelmyto, its first approved product, as awareness increases with the launch of UGN-102 [51] - 2026 is expected to be a pivotal year for UroGen, with the first two quarters crucial for demonstrating market potential [53]

Group 1 - Brendan, a Pennsylvanian, completed a Ph.D. in organic synthesis at Stanford University in 2009 [1] - He worked for Merck from 2009 to 2013 and has experience in biotech startups such as Theravance and Aspira before joining Caltech [1] - Brendan is a co-founder and the first employee of 1200 Pharma, which spun out of Caltech and received significant investment in the 8 figures [1] - He remains an avid investor focused on market trends, particularly in biotechnology stocks [1]

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Core Insights - UroGen Pharma Ltd. will present at the Piper Sandler 37th Annual Healthcare Conference on December 2-4, 2025 [1][2] - The presentation will take place on December 2, 2025, at 1:00 PM ET in a fireside chat format [2] - UroGen is focused on developing innovative solutions for urothelial and specialty cancers, utilizing proprietary technologies [3] Company Overview - UroGen Pharma Ltd. is dedicated to treating urothelial and specialty cancers, aiming to provide better treatment options for patients [3] - The company has developed RTGel, a reverse-thermal hydrogel technology that allows for sustained release of medications, potentially enhancing therapeutic effectiveness [3] - UroGen's first product targets low-grade upper tract urothelial carcinoma (LG-UTUC), while its second product is an intravesical solution for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) [3] - The company is headquartered in Princeton, NJ, with operations in Israel [3]

Core Insights - UroGen Pharma Ltd. (NASDAQ:URGN) is recognized as a promising small-cap biotech stock by analysts [1] Financial Performance - For Q3 2025, UroGen Pharma reported a net loss of $33.3 million, an increase from $23.7 million in Q3 2024, primarily due to rising R&D expenses and delayed revenue recognition [4] - The company ended the quarter with $127.4 million in cash and marketable securities [2] Revenue Growth - Preliminary figures for October indicate that demand revenue more than doubled compared to the previous three months, reflecting increased physician adoption despite operational delays [2] - UroGen provided revenue guidance for its product JELMYTO, expecting net revenues between $94 million and $98 million for the full year [4] Market Position and Strategy - The company is expanding its sales force to 82 representatives to enhance physician outreach and patient access, achieving coverage for over 95% of insured lives [3] - With the implementation of a permanent billing code in early 2026, UroGen anticipates a smoother reimbursement process, although administrative lags of up to 60 days may still occur [3] Product Focus - UroGen Pharma specializes in developing and marketing specialty cancer treatments, offering targeted and minimally invasive therapies [5]

Core Viewpoint - Small-cap biotech stocks are experiencing a resurgence, driven by market rotation and improving technical indicators, with healthcare emerging as a constructive sector [2][4] Industry Overview - The Health Care Select Sector SPDR Fund (XLV) has increased by 11.09% in 2025, while the iShares Biotechnology ETF has gained approximately 25% year-to-date [2][3] - Analysts suggest that capital is flowing out of high-flying AI stocks into more attractive healthcare and biotech opportunities [3][4] M&A Activity - Increased mergers and acquisitions (M&A) activity in the biotech sector has been noted, with significant deals including Pfizer's $10 billion acquisition of Metsera and Roche's $3.5 billion acquisition of 89bio [4][5] - This M&A activity is expected to bolster potential upside for both large-cap and small-to-mid-cap biotech companies [4] Methodology for Stock Selection - The list of the best small-cap biotech stocks was curated based on companies with market capitalizations between $300 million and $2 billion, focusing on those with the highest upside potential as of November 10, 2025 [8] Company Highlights - **Viridian Therapeutics, Inc. (NASDAQ:VRDN)**: - Upside potential of 36.71% with a cash position of $888 million and key patient enrollments in late-stage clinical studies [10][11][12] - **UroGen Pharma Ltd. (NASDAQ:URGN)**: - Upside potential of 49.17%, reporting a significant increase in demand revenue and a cash position of $127.4 million [14][15][16] - **Liquidia Corporation (NASDAQ:LQDA)**: - Upside potential of 55.49%, with YUTREPIA achieving profitability earlier than expected and a cash position of $157.5 million [19][20][22]

UroGen Pharma FY Conference Summary Company Overview - **Company**: UroGen Pharma (NasdaqGM:URGN) - **Technology**: RTGel technology, a unique polymer combination that forms a soft gel at body temperature, facilitating drug delivery to the bladder and upper urinary tract [2][3] Core Product Insights - **Product**: Jelmyto, approved for bladder cancer treatment - **Market Opportunity**: Approximately 60,000 patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC) [4] - **Unmet Medical Need**: High recurrence rates among patients, with 23% experiencing five or more recurrences and 68% having two or more [4] Market Dynamics - **Patient Population**: Focus on low-grade disease, which is highly recurrent but not life-threatening [6][7] - **Surgical Failures**: Current treatments often lead to repetitive surgeries, highlighting the need for effective non-surgical options [4][6] Launch and Sales Strategy - **Sales Force Expansion**: Increased from 40 to 82 representatives to support the launch of UGN-102, with a focus on clinical nurse educators [10][11] - **Reimbursement Challenges**: Identified as the biggest barrier to adoption; efforts are in place to address this with field reimbursement teams [10][11][19] Early Launch Metrics - **Revenue Performance**: $1.8 million in Q3 and $4.5 million in October, indicating strong early adoption [14][15] - **Patient Enrollment Forms**: Early indicators of demand are on par with Jelmyto's performance after five years, suggesting a strong market interest [15][16] Future Growth Potential - **J Code Impact**: Anticipated positive effects on revenue post-J code implementation in January 2026, with expectations of increased physician confidence and reimbursement facilitation [18][19] - **Market Penetration**: Projected peak market penetration of over $1 billion, with a conservative estimate of 20% market share [22] Competitive Landscape - **First-Mover Advantage**: UroGen Pharma is positioned as a primary therapy for low-grade intermediate-risk bladder cancer, differentiating from competitors that require surgery [24][25] - **Future Products**: Competitors like J&J and CG are developing adjuvant therapies, which may follow surgical interventions, contrasting with UroGen's non-surgical approach [25][26] Pipeline Developments - **UGN-103**: A new formulation of mitomycin with improved production efficiency, expected to file for NDA in the second half of 2026 [30][31] - **UGN-104**: Successor product for Jelmyto, anticipated to follow UGN-103 by about a year [34] - **Oncolytic Virus (501)**: Currently in IND enabling studies, with potential applications beyond bladder cancer [35][36] Commercial Synergies - **Cross-Promotion**: Increased commercial efforts around UGN-102 are expected to drive growth for Jelmyto, as physicians become more familiar with both products [38] Conclusion UroGen Pharma is strategically positioned in the bladder cancer treatment market with innovative technology and a strong pipeline. The company is addressing significant unmet needs in patient care while navigating challenges related to reimbursement and market adoption. The anticipated impact of the J code and the first-mover advantage in the low-grade intermediate-risk segment are expected to drive future growth.