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PRINCETON, N.J. - UroGen Pharma Ltd. (NASDAQ:URGN), a pharmaceutical company with an impressive gross profit margin of nearly 90%, announced Monday that a Phase 3b study has demonstrated the feasibility of administering its bladder cancer treatment ZUSDURI in home settings by trained healthcare professionals. The company’s stock has shown remarkable momentum, gaining over 76% in the past six months and currently trading near its 52-week high of $19.15. According to InvestingPro analysis, the company appears slightly undervalued based on its Fair Value metrics.
The study, published in Reviews in Urology, evaluated home administration of ZUSDURI (mitomycin) for intravesical solution in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
Six of eight patients (75%) completed all six scheduled treatments, with the first dose administered in a clinic and the remaining five doses given at home by home health professionals. The study reported a 75% complete response rate at three months.
According to the press release, five of the six patients who completed treatment indicated they would recommend the home-based approach to others. Investigators found no meaningful differences between home and office administration for most patients.
"The ability to deliver this treatment safely and effectively at home has the potential to ease the burden on patients and reduce reliance on hospital or clinic resources," said David Morris, lead investigator and practicing urologist at Urology Associates in Nashville.
The safety profile was consistent with previous studies, with most adverse events being mild-to-moderate urinary symptoms. Study limitations included the small sample size and the open-label, single-arm design.
ZUSDURI utilizes UroGen’s proprietary RTGel technology, a sustained-release hydrogel formulation delivered directly into the bladder via urinary catheter. The treatment is approved for adults with recurrent LG-IR-NMIBC, a condition that affects approximately 82,000 people in the U.S. annually, with an estimated 59,000 experiencing recurrence. With revenue growth of nearly 9% and a strong liquidity position reflected in its current ratio of 5.65, UroGen appears well-positioned to capitalize on this market opportunity. For deeper insights into UroGen’s financial health and growth potential, InvestingPro subscribers can access comprehensive analysis and 13 additional ProTips about the company’s performance.
The company noted that the standard treatment for this condition typically involves surgical tumor removal, but the home administration approach could potentially offer a more convenient alternative for patients, particularly older individuals who may face challenges traveling to frequent clinic visits. With a market capitalization of $875 million and strong institutional backing, UroGen continues to advance its innovative treatment solutions. Discover more about UroGen’s market position and growth prospects through the detailed Pro Research Report, available exclusively on InvestingPro, along with in-depth analysis of 1,400+ other US stocks.
In other recent news, UroGen Pharma Ltd. announced the completion of patient enrollment in its Phase 3 UTOPIA clinical trial for UGN-103, a mitomycin formulation designed to treat recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. This trial enrolled 99 patients across multiple global centers and utilizes the company’s proprietary RTGel technology for sustained drug release. Additionally, UroGen’s bladder cancer drug ZUSDURI has shown a durable response, with patients maintaining event-free status for a median of two years after achieving complete response, as published in the journal Clinical Genitourinary Cancer. Following the FDA approval of ZUSDURI, H.C. Wainwright upgraded UroGen Pharma’s stock rating to "Buy" with a price target of $50.00. The approval marks ZUSDURI as the first and only FDA-approved medication for adults with this type of bladder cancer. Furthermore, UroGen Pharma’s board awarded special bonuses to three executive officers, recognizing their leadership and contributions leading up to the FDA approval. Elizabeth Barrett, the President and CEO, received a bonus of $645,000, while Chris Degnan and Jason Smith each received $100,000. These developments highlight significant progress and recognition for UroGen Pharma in the field of bladder cancer treatment.
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