UroGen’s bladder cancer drug shows durable response in long-term study

PRINCETON, N.J. - UroGen Pharma Ltd. (NASDAQ:URGN), a biotechnology company with a market capitalization of $704 million and impressive gross profit margins of nearly 90%, announced that patients treated with its bladder cancer drug ZUSDURI (mitomycin) maintained event-free status for a median of two years after achieving complete response, according to findings published in the journal Clinical Genitourinary Cancer. InvestingPro analysis shows the company has achieved revenue growth of 9% over the last twelve months.

The five-year long-term extension study of the Phase 2b OPTIMA II trial evaluated ZUSDURI in patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). Among the 17 patients who achieved complete response and entered the long-term extension study, the median duration of response was 3.5 years.

Of the 41 patients who initially achieved complete response at three months post-treatment in the OPTIMA II trial, 25 remained in complete response at 12 months. For these 41 patients, the median duration of response was 24.2 months with a median follow-up of 35.8 months.

"Low-grade intermediate-risk bladder cancer is a chronic, recurring disease that often requires repeated surgical intervention," said Neal D. Shore, MD, lead author of the study, in the press release.

The study primarily included recurrent patients, with 16 of the 17 long-term follow-up participants (94%) having recurrent disease. ZUSDURI is specifically indicated for adults with recurrent LG-IR-NMIBC.

According to the company, LG-IR-NMIBC affects approximately 82,000 people in the U.S. annually, with an estimated 59,000 experiencing recurrence. The company’s stock has shown strong momentum, with a 50% price return over the past six months. InvestingPro subscribers can access 12 additional expert tips and comprehensive analysis through the Pro Research Report, offering deeper insights into UroGen’s market position and growth potential.

ZUSDURI utilizes UroGen’s proprietary RTGel technology, a sustained-release hydrogel formulation delivered directly into the bladder through a catheter in an outpatient procedure.

The most common side effects reported in the original OPTIMA II study included dysuria (41%), pollakiuria (21%), and hematuria (16%). No safety data were collected during the long-term follow-up trial. While the company maintains strong liquidity with a current ratio of 5.65, InvestingPro data indicates it’s currently burning through cash, making it crucial for investors to monitor its financial health through comprehensive analysis available in the Pro Research Report.

In other recent news, UroGen Pharma has made significant strides with its Phase 3 UTOPIA clinical trial for UGN-103, completing enrollment of 99 patients across global centers. This trial aims to treat recurrent low-grade intermediate-risk non-muscle invasive bladder cancer using UroGen’s proprietary RTGel technology. H.C. Wainwright has reiterated a Buy rating for UroGen Pharma, maintaining a $50 price target, due to the trial’s progress and potential FDA filing next year. The company also received a Notice of Allowance from the U.S. Patent and Trademark Office, with patent protection for UGN-103 expected through December 2041.

Following the FDA approval of ZUSDURI, UroGen Pharma’s stock rating was upgraded to Buy by H.C. Wainwright, which also projected a $50 price target. Oppenheimer increased its price target for UroGen Pharma from $10 to $31, maintaining an Outperform rating after the approval of ZUSDURI. The FDA approval was based on successful Phase 3 trial results, with ZUSDURI showing a 78% complete response rate. In recognition of their efforts leading up to the FDA approval, UroGen Pharma awarded special bonuses to three executive officers. The company plans to initiate a Phase 3 trial for UGN-104 in the near future, further expanding its treatment options.

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