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UroGen Pharma Ltd. (NASDAQ:URGN), a pharmaceutical company with a market capitalization of $511 million, announced on Thursday that the U.S. Food and Drug Administration (FDA) has approved ZUSDURI™ (mitomycin), a gel for the treatment of adults with low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The news catalyzed a remarkable 50% surge in the company’s stock price over the past week, according to InvestingPro data. The product, previously known as UGN-102, is a sustained-release formulation designed to treat recurrent cases of the disease.
The FDA’s approval is supported by results from the Phase 3 ENVISION trial, which showed a 78% complete response rate at three months, with 79% of these patients maintaining their response after a year. ZUSDURI’s most common adverse reactions included increased creatinine, potassium levels, dysuria, and decreased hemoglobin, among others. Serious adverse reactions were reported in 12% of patients. InvestingPro analysis reveals the company maintains impressive gross profit margins of nearly 90%, though it currently operates at a loss.
ZUSDURI is expected to be available in the U.S. starting July 1, 2025. As part of the post-marketing commitment, UroGen Pharma has agreed to continue the ENVISION trial to further assess the treatment’s benefits and provide the FDA with interim reports and annual updates on the duration of response data.
The company’s forward-looking statements caution that there are risks and uncertainties associated with the commercial launch of a new product, and new data from ongoing trials or adverse event reports could affect ZUSDURI’s market performance or lead to changes in its label.
The information in this article is based on a press release statement.
In other recent news, UroGen Pharma received full FDA approval for its bladder cancer treatment, Zusduri, marking a significant milestone for the company. The approval came despite a negative vote from the FDA’s Oncologic Drugs Advisory Committee, which had recommended against it. Following the approval, Guggenheim raised its price target for UroGen to $30.00, maintaining a Buy rating and highlighting the approval as a "best-case scenario" for the company. Scotiabank (TSX:BNS) also increased its price target to $47.00, maintaining a Sector Outperform rating, and noted the FDA’s decision underscores the drug’s positive benefit/risk profile.
UroGen’s Zusduri is the first FDA-approved medication for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, offering a non-surgical treatment alternative. The drug demonstrated a 78% complete response rate in Phase 3 trials, with 79% of responders remaining event-free after a year. Analysts at Guggenheim project Zusduri could capture 15% of the market, potentially generating $800 million in U.S. sales by 2030. Meanwhile, Oppenheimer adjusted its outlook on UroGen, lowering the price target to $10 but maintaining an Outperform rating, expressing optimism for the drug’s approval prospects. The medication is set to be commercially available starting July 1, with UroGen committing to ongoing updates from the ENVISION trial.
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