UroGen Announces New Data Presentations at the Society of Urologic Oncology 2024 Annual Meeting Highlighting Urothelial Cancer Portfolio Aimed at Addressing Unmet Needs
URGN 12.02.2024
About Gravity Analytica
Recent News
- 01.22.2025 - 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)
- 01.15.2025 - 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
- 12.06.2024 - UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Recent Filings
"We are excited that the SUO has accepted data highlighting the potential of our investigational treatment, UGN-102, in development for patients with low-grade, intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC), as well as the ongoing clinical value of JELMYTO for treating low-grade upper tract urothelial carcinoma (LG-UTUC)," said
Key details of UGN-102, JELMYTO and UGN-301 abstracts accepted by SUO:
Abstract Title | Schedule | Presenter |
PRIMARY CHEMOABLATION OF RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE-INVASIVE BLADDER CANCER WITH UGN-102: A SINGLE-ARM, OPEN-LABEL, PHASE 3 TRIAL (ENVISION) | Poster 121 Date: 12/5 Time: | Dr. |
LONG-TERM OUTCOMES OF PRIMARY CHEMOABLATION OF LOW-GRADE UPPER TRACT UROTHELIAL CARCINOMA (LG-UTUC) WITH UGN-101, A MITOMYCIN REVERSE THERMAL GEL | Poster 122 Date: 12/5 Time: | Dr. |
HOME INSTILLATION OF UGN-102 FOR PRIMARY CHEMOABLATION OF RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE-INVASIVE BLADDER CANCER: A SINGLE-ARM, OPEN-LABEL, PHASE 3B TRIAL | Poster 124 Date: 12/5 Time: 2:15 – | Dr. |
A PHASE 1 DOSE-ESCALATION STUDY OF UGN-301 (ZALIFRELIMAB) IN PATIENTS WITH RECURRENT NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) | Poster 133 Date: 12/5 Time: 2:15 – | |
A PHASE 1 DOSE-ESCALATION STUDY OF UGN-301 (ZALIFRELIMAB) AS MONOTHERAPY AND IN COMBINATION WITH OTHER AGENTS IN PATIENTS WITH RECURRENT NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) | Poster 206 Date: 12/6 Time: 10:00 – |
For further information about UroGen’s ongoing clinical trials and programs, please visit our website aturogen.comto learn more or follow us on X (Twitter), @UroGenPharma.
About UGN-102
UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietaryRTGel® technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting by a trained healthcare professional. UroGen completed the NDA submission in August, ahead of schedule. The FDA accepted the NDA for UGN-102 and assigned a PDUFA goal date of
About JELMYTO
JELMYTO® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for the treatment of adult patients with LG-UTUC. It is recommended for primary treatment of biopsy-proven LG-UTUC in patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.
UGN-301
UGN-301 is our investigational, in-licensed, anti-CTLA-4 monoclonal antibody (zalifrelimab), prepared with reverse-thermal hydrogel for intravesical administration into the bladder. Intravesical administration of UGN-301 is designed to increase drug concentrations in the bladder without significant systemic exposure, potentially diminishing the systemic toxicity associated with CTLA-4 blockade. UroGen is evaluating UGN-301 as combination therapy for the intravesical treatment of high-grade NMIBC.
About
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, 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. Our first product to treat LG-UTUC and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer are designed to ablate tumors by non-surgical means. UroGen is headquartered in
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the potential benefits of UGN-102 and UGN-301; the future development of UGN-301; the potential of UroGen’s proprietaryRTGeltechnology to improve therapeutic profiles of existing drugs; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: our development plans for UGN-301 may change for a variety of reasons, including data and other program considerations; even though the NDA for UGN-102 has been accepted for filing by the FDA, there is no guarantee that such NDA will be sufficient to support approval of UGN-102 on the timeframe expected, or at all; the ability to maintain regulatory approval; complications associated with commercialization activities; the labeling for any approved product; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; UroGen’s ability to attract or retain key management, members of the board of directors and other personnel; UroGen’sRTGeltechnology may not perform as expected; and UroGen may not successfully develop and receive regulatory approval of any other product that incorporatesRTGeltechnology. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended
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