Shares of UroGen Pharma Ltd. (NASDAQ: URGN) experienced a notable upswing on the US stock charts following a pivotal regulatory milestone. The stock closed Thursday’s regular trading session with a gain of over 51%, ending at $11.08, and extended its rally after-hours by another 8.21% to settle at $11.99.
First FDA-Approved Therapy for Recurrent LG-IR-NMIBC
The surge came after UroGen (URGN) announced the U.S. Food and Drug Administration (FDA) approval of ZUSDURI, a groundbreaking treatment for recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
ZUSDURI, a combination of mitomycin and URGN’s proprietary RTGel hydrogel technology, is now the first and only FDA-approved drug for adult patients with recurrent LG-IR-NMIBC. Its approval is supported by compelling Phase 3 data from the ENVISION trial, which demonstrated a 78% complete response rate at 3 months.
At the 12-month point, 79% of individuals who received a full response continued to be event-free. This innovative treatment offers a long-needed substitute for the transurethral resection of bladder tumor (TURBT), the current surgical standard of care. TURBT is frequently carried out under general anesthesia and necessitates many treatments because of its high recurrence rate.
A New Era in Bladder Cancer Management
ZUSDURI represents a significant advancement in the field of uro-oncology, especially for the estimated 59,000 U.S. patients who face recurrent LG-IR-NMIBC each year. Unlike traditional TURBT surgery, ZUSDURI offers a non-surgical, drug-based solution that could greatly reduce patient burden. Its U.S. launch is anticipated on or around July 1, 2025.
Commitment to Patient Access and Ongoing Research
URGN has affirmed its commitment to supporting patient access through the UroGen Support program, designed to help eligible individuals navigate financial assistance options across insurance types.
Additionally, UroGen will continue the ENVISION trial as part of a post-marketing agreement with the FDA. Annual updates on treatment duration and clinical outcomes will be submitted until long-term benchmarks are met, ensuring transparency and ongoing evaluation of ZUSDURI’s effectiveness in real-world use.
