UroGen completes enrollment in phase 3 bladder cancer trial

PRINCETON, N.J. - UroGen Pharma Ltd. (NASDAQ:URGN), a $626 million market cap biotechnology company with impressive gross profit margins of nearly 90%, announced Monday it has completed patient enrollment in its Phase 3 UTOPIA clinical trial of UGN-103 for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.

The trial enrolled 99 patients across multiple centers globally to evaluate UGN-103, a mitomycin formulation that uses the company’s proprietary RTGel technology for sustained drug release in the bladder.

According to the company, UGN-103 is designed to offer improvements over ZUSDURI, including a shorter manufacturing process and simplified reconstitution procedure. Both treatments utilize the same RTGel technology that enables prolonged exposure of medication to bladder tissue.

"Completing enrollment in the UTOPIA trial marks a significant milestone in our efforts to advance UGN-103 as a next-generation treatment option," said Michael Louie, EVP of Medical Affairs and Clinical Development at UroGen, in the press release.

The single-arm study administers 75 mg of UGN-103 via intravesical instillation once weekly for six weeks to all enrolled patients. The primary endpoint is complete response rate at three months, with responders entering a follow-up phase of up to 12 months.

UroGen received a Notice of Allowance from the U.S. Patent and Trademark Office in September 2024 covering the use of UGN-103, with patent protection expected through December 2041.

Low-grade intermediate-risk non-muscle invasive bladder cancer affects approximately 82,000 people in the U.S. annually, with an estimated 59,000 experiencing recurrent disease, according to the company’s statement.

UroGen’s first product, ZUSDURI, is expected to be available in the U.S. on or around July 1, 2025.

In other recent news, UroGen Pharma has announced the FDA approval of its bladder cancer treatment, Zusduri, which marks a significant development for the company. The approval is based on the Phase 3 ENVISION trial results, showing a 78% complete response rate at three months, with 79% of patients maintaining their response after a year. Following this approval, UroGen Pharma awarded special bonuses to three of its executives, recognizing their leadership and contributions. Additionally, the company has set the list price for Zusduri at $21,500 per dose and plans to make it available in the U.S. starting July 1, 2025.

Analysts have responded positively to these developments. H.C. Wainwright upgraded UroGen Pharma’s stock rating from neutral to buy, with a price target of $50.00. Oppenheimer also raised its price target from $10.00 to $31.00, maintaining an Outperform rating. Guggenheim increased its price target to $30.00 from $15.00, citing the approval as a "best-case scenario" for the company. These upgrades reflect optimism about the drug’s market potential, with projections suggesting significant sales growth in the coming years. UroGen Pharma’s ongoing commitment includes completing the ENVISION trial to provide further data on the treatment’s benefits.

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