On April 14, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that data on investigational drug UGN-102 (mitomycin) for intravesical solution, JELMYTO (mitomycin) for pyelocalyceal solution and UGN-301 (zalifrelimab) will be presented at the American Urological Association (AUA) 2025 Annual Meeting being held in Las Vegas, Nevada from April 26-29 (Press release, UroGen Pharma, APR 14, 2025, View Source [SID1234651908]).

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"We are thrilled to present the 18-month DOR data on UGN-102, along with additional data on JELMYTO and our investigational drug UGN-301 (zalifrelimab) an anti-CTL4 antibody in development for the treatment of recurrent non-muscle invasive bladder cancer, at the AUA Annual Meeting," said Mark Schoenberg, Chief Medical Officer, UroGen. "These data highlight the potential of our portfolio to offer significant advancements in the treatment of urothelial cancers."

Key details of UGN-102, JELMYTO and UGN-301 abstracts accepted by AUA:

UGN-102

Abstract Title

Presentation Details

Presenter

Treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer with UGN-102: ongoing results from a single-arm, open-label, phase 3 trial (ENVISION)

Podium Oral Presentation:

Abstract ID: PD12 – Galileo 1001

Saturday, April 26, 2025

3:30 PM – 5:30 PM

Dr. Sandip Prasad

Patient-reported side-effect burden for patients with low-grade intermediate-risk non-muscle invasive bladder cancer receiving treatment with UGN-102 (UGN-102 Integrated PROs)

Moderated Poster – MP15

Marco Polo 703

Sunday, April 27, 2025

9:30 AM – 11:30 AM

Dr. Charles Peyton

Treatment of low-grade intermediate-risk non-muscle invasive bladder cancer with UGN-102: long-term outcomes of the (OPTIMA II LT study)

Moderated Poster – MP15 –

Marco Polo 703

Sunday, April 27, 2025

9:30 AM – 11:30 AM

Dr. Neal Shore

JELMYTO

Long-term outcomes of treatment of recurrent or new-onset low-grade upper tract urothelial carcinoma with UGN-101, a mitomycin reverse thermal gel (OLYMPUS LT)

Interactive poster – IP12 – Casanova 501

Sunday, April 27, 2025

1:00 PM – 3:00 PM (IP12)

Dr. Brian Hu

UGN-301

Treatment of recurrent non-muscle invasive bladder cancer with UGN-301 (zalifrelimab): results of a phase 1 dose-escalation study (UGN-301-MONO)

Interactive Poster – IP02 – Marco Polo 701

Saturday, April 26, 2025

7:00 AM – 9:00 AM

Dr. Jay Raman

UroGen is a Founders’ Circle Sponsor of the AUA Innovation Nexus Conference
UroGen’s President and Chief Executive Officer, Liz Barrett, will participate in a Showcase Panel discussion on April 25, alongside exciting urology startups that span the globe and are developing products—devices, artificial intelligence platforms, diagnostic tests, etc.—covering a variety of urologic issues such as prostate and bladder cancer, kidney injuries, fertility testing, nocturnal enuresis, overactive bladder, and interstitial cystitis. Liz will also take part in the Founders’ Circle Awards Presentation.

The AUA Innovation Nexus is a powerful forum to advance urologic discovery to solutions that improve patient care and save lives. Register here: View Source

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 recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel 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 submission of the rolling new drug application (NDA) for UGN-102 in August 2024, ahead of schedule. The FDA accepted the NDA for UGN-102 and assigned a Prescription Drug User Free Act (PDUFA) goal date of June 13, 2025.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
In the U.S., bladder cancer is the second most common urologic cancer in men. LG-IR-NMIBC represents approximately 23,000 newly diagnosed bladder cancer patients each year and an estimated 59,000 recurrences annually among patients diagnosed in previous years. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include trans-urethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures.

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.

About 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 a monotherapy and as combination therapy for the intravesical treatment of high-grade NMIBC. UroGen is evaluating UGN-301, in a multi-arm Phase 1 study of UGN-301 as monotherapy and in combination with other agents.