UroGen Announces FDA Clearance of the IND for UGN-501, an Investigational Next-Generation Oncolytic Virus for Non-Muscle Invasive Bladder Cancer

• FDA clearance enables initiation of a planned Phase 1 clinical study evaluating local intravesical administration of UGN-501, with patient enrollment expected to begin in Q4 2026
• UGN-501 is a differentiated investigational next-generation oncolytic virus designed to combine direct tumor cell destruction with anti-tumor immune activation

PRINCETON, N.J., July 08, 2026 — UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational New Drug application (IND) for UGN-501, a next-generation investigational oncolytic virus. The IND clearance enables initiation of a planned Phase 1 clinical study in patients with non-muscle invasive bladder cancer (NMIBC). The Phase 1 study is expected to begin in Q4 2026 and will evaluate the safety, tolerability, and feasibility of intravesical administration of UGN-501.

"Patients with non-muscle invasive bladder cancer continue to face a significant risk of disease recurrence despite available treatment options," said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. "UGN-501 is an investigational next-generation oncolytic virus designed to selectively destroy tumor cells while generating an anti-tumor immune response. FDA clearance of the IND allows us to begin evaluating whether the encouraging nonclinical profile of UGN-501 can translate into a safe and meaningful therapeutic approach for patients with NMIBC. We look forward to initiating the Phase 1 study and advancing our efforts to develop innovative treatment options for patients with bladder cancer."

NMIBC continues to present significant clinical challenges, particularly among patients whose disease recurs following standard treatment. Despite available therapies, recurrence rates remain substantial, underscoring the need for novel bladder-sparing therapeutic approaches. UroGen believes UGN-501's differentiated mechanism of action and local administration strategy may offer a promising new approach for addressing this unmet need.

About UGN-501

UGN-501 is an investigational, next-generation oncolytic virus being investigated for the treatment of non-muscle invasive bladder cancer (NMIBC). UGN-501 is designed to selectively replicate within tumor cells, resulting in direct tumor cell destruction and an anti-tumor immune response. The program is supported by nonclinical data demonstrating cytotoxic activity across a broad panel of bladder cancer cell lines representing multiple stages and grades of disease. While UGN-501 is initially being developed for bladder cancer, the Company believes UGN-501's underlying properties may have broader applicability across additional solid tumor indications and intends to evaluate future development opportunities based on emerging clinical and translational data.

About UroGen Pharma Ltd.

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 low-grade upper tract urothelial cancer and our second product to treat adult patients with recurrent LG-IR-NMIBC, are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel.

Visit www.UroGen.com to learn more or follow us on X (formerly Twitter), @UroGenPharma.