FDA to review UroGen’s bladder cancer drug on May 21

PRINCETON, N.J. - UroGen Pharma Ltd. (NASDAQ: URGN), a biotech company specializing in urothelial and specialty cancer treatments, announced today that the U.S. Food and Drug Administration (FDA) has set a meeting for May 21, 2025, to discuss the new drug application for UGN-102, a potential treatment for bladder cancer. According to InvestingPro data, the company maintains impressive gross profit margins of over 90%, though it’s currently trading below its Fair Value, potentially presenting an opportunity for investors interested in the biotech sector.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) will review data for UGN-102 (mitomycin) for intravesical solution, which is under investigation for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The ODAC’s role is to provide independent expert advice to the FDA, but the agency is not obligated to follow the committee’s recommendations.

UGN-102 is a formulation of mitomycin using UroGen’s proprietary RTGel technology, intended to allow prolonged exposure of bladder tissue to the drug and offer a non-surgical treatment option. The application is supported by the Phase 3 ENVISION trial, which showed a 79.6% complete response rate at three months post-treatment and an 82.5% duration of response at 12 months.

The FDA plans to decide on the approval of UGN-102 by the Prescription Drug User Fee Act (PDUFA) target date of June 13, 2025. Liz Barrett, President and CEO of UroGen, expressed optimism about presenting their data and the potential benefits of UGN-102 for patients with bladder cancer.

Bladder cancer is the second most common urologic cancer in men in the U.S., with LG-IR-NMIBC representing about 23,000 new cases annually and an estimated 59,000 recurrences every year. Current treatment primarily involves surgical procedures that patients may have to undergo repeatedly due to the high recurrence rate of the disease.

UroGen’s focus is on developing solutions that could improve treatment outcomes for patients with urothelial cancers. This includes leveraging their RTGel technology to enhance the effectiveness of existing drugs through sustained release formulations.

The information in this article is based on a press release statement from UroGen. For deeper insights into UroGen’s financial health, valuation metrics, and extensive analysis, investors can access the comprehensive Pro Research Report available on InvestingPro, which covers over 1,400 US stocks with detailed financial analysis and expert insights.

In other recent news, UroGen Pharma reported fourth-quarter earnings that did not meet analyst expectations, with revenue at $24.56 million, falling short of the consensus estimate of $28.24 million. The company’s flagship product, JELMYTO, generated $24.6 million in net product revenue for the quarter, marking an increase from the previous year’s $23.5 million. For the full year 2024, JELMYTO achieved net product revenue of $90.4 million, compared to $82.7 million in 2023. UroGen Pharma ended the year with a strong cash position of $241.7 million in cash, cash equivalents, and marketable securities. Analysts from Raymond James and H.C. Wainwright have adjusted their price targets for UroGen Pharma, with Raymond James reducing it to $36 and H.C. Wainwright to $55, while maintaining Outperform and Buy ratings, respectively. The company is preparing for the commercial launch of UGN-102, a treatment for non-muscle invasive bladder cancer, and expects full-year 2025 JELMYTO net product revenues between $94 million to $98 million. Analyst Reni Benjamin from Raymond James projects UroGen Pharma’s total product sales to reach $750 million by 2029. Despite the revenue shortfall, UroGen’s net loss for the year was narrower than anticipated, and the company remains focused on its growth strategy in uro-oncology.

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