UroGen soars 50% on FDA approval of historic bladder cancer treatment
Investing.com -- Shares of UroGen Pharma Ltd. (NASDAQ:URGN) jumped 50% Thursday after the company announced FDA approval of ZUSDURI, marking the first and only intravesical medication cleared for adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The green light makes ZUSDURI a new non-surgical option for an estimated 59,000 U.S. patients annually who often undergo repeated transurethral resection procedures under general anesthesia.
ZUSDURI combines mitomycin with UroGen’s proprietary RTGel® delivery platform, offering sustained drug release directly to the bladder. In Phase 3 trials, the therapy demonstrated a 78% complete response rate at three months, with 79% of those responders remaining event-free a year later.
“The approval of ZUSDURI represents a significant step forward for our company and for the treatment of recurrent LG-IR-NMIBC,” said Liz Barrett, President and CEO of UroGen. “This historic achievement is a bold leap forward in our mission to redefine uro-oncology and bring innovation to patients who need it most.”
The standard of care for LG-IR-NMIBC has long relied on transurethral resection of bladder tumor (TURBT), a procedure that does not address the persistent recurrence faced by many patients. UroGen’s ZUSDURI offers a non-invasive alternative aimed at reducing the frequency and need for surgical resections over a patient’s lifetime.
“ZUSDURI marks a breakthrough in uro-oncology,” said Dr. Sandip Prasad, MD, M.Phil., principal investigator of the ENVISION trial. “For decades, TURBT has been the standard approach for bladder cancer treatment. That’s why innovative treatments like ZUSDURI are essential.”
While the treatment was generally well tolerated, adverse reactions occurred in a minority of patients. The most common side effects included dysuria and urinary tract infections, with serious adverse events like urinary retention and urethral stenosis observed in under 1% of cases.
The FDA’s approval represents a major commercial and clinical milestone for UroGen, whose pipeline has focused on urothelial cancers with high recurrence rates. Analysts expect ZUSDURI to quickly become the new standard in bladder cancer care, providing a recurring revenue stream and a crucial option for a large, underserved patient population.
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