FDA approves UroGen’s ZUSDURI for bladder cancer treatment

PRINCETON, N.J. - The U.S. Food and Drug Administration has approved ZUSDURI (mitomycin) for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), UroGen Pharma Ltd. (NASDAQ:URGN) announced. The news sparked a 42% surge in the company’s stock price over the past week, though shares remain significantly below their 52-week high of $20.70. According to InvestingPro data, UroGen maintains a market capitalization of $330.59 million.

ZUSDURI is the first FDA-approved medication specifically for this condition, which affects an estimated 59,000 patients annually in the U.S. who face recurring tumors and repeated surgical procedures. The company boasts impressive gross profit margins of nearly 90%, according to InvestingPro analysis, which offers 8 additional key insights about UroGen’s financial health.

The approval is based on results from the Phase 3 ENVISION trial, which showed a 78% complete response rate at three months, with 79% of those responders maintaining complete response 12 months later.

"For the first time, patients facing recurrent LG-IR-NMIBC have access to an FDA-approved medicine," said Liz Barrett, President and CEO of UroGen, in a statement based on the press release.

ZUSDURI utilizes UroGen’s proprietary RTGel technology to deliver sustained-release mitomycin directly to the bladder through a catheter in an outpatient procedure. This approach offers an alternative to the current standard of care, which typically involves surgical tumor removal under general anesthesia.

Common adverse reactions included increased creatinine, increased potassium, dysuria, decreased hemoglobin, and urinary tract infection. Serious adverse reactions occurred in 12% of patients.

The medication is expected to be available in the U.S. around July 1, 2025. As part of its approval, UroGen has committed to complete the ongoing ENVISION trial and provide annual updates on duration of response to the FDA. Analysts maintain a bullish outlook on UroGen’s prospects, with price targets ranging from $3 to $35 per share. For detailed financial analysis and comprehensive insights, investors can access the full Pro Research Report available on InvestingPro, which provides in-depth coverage of UroGen among 1,400+ top US stocks.

In other recent news, UroGen Pharma has been in the spotlight due to several significant developments. The company announced promising results from its ENVISION and ATLAS studies, which were presented at the American Society of Clinical Oncology Annual Meeting. These studies focused on UGN-102, a treatment currently in Phase 3 trials for bladder cancer, showing an 18-month duration of response. Despite these promising results, the Oncologic Drugs Advisory Committee (ODAC) narrowly voted against the favorable benefit-risk profile of UGN-102, casting doubt on its approval for broad indications.

Oppenheimer analysts maintained an Outperform rating but lowered their price target for UroGen Pharma to $10, expressing optimism about the potential approval of UGN-102. Meanwhile, Goldman Sachs significantly reduced its price target from $16 to $3, reflecting skepticism after the ODAC’s vote. The FDA’s decision on UGN-102 is anticipated by June 13, 2025, a crucial date for the company. UroGen Pharma’s management remains committed to working with the FDA despite the challenges highlighted by the advisory committee’s vote. Investors are closely monitoring these developments as they await the FDA’s final decision.

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