PRINCETON, N.J. - UroGen Pharma Ltd. (NASDAQ: URGN), a biotech company with a market capitalization of $419 million and impressive gross profit margins of 90%, reported positive results from its Phase 3 ENVISION study of UGN-102 as a treatment for patients with low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). The study found a 79.6% complete response rate at three months and an 82.3% duration of response at one year. According to InvestingPro data, the company has shown strong revenue growth of 15.6% over the last twelve months.
The ENVISION trial, which was designed to evaluate the efficacy and safety of UGN-102, met its primary endpoint with the three-month complete response rate. The trial also demonstrated a notable durability of response over a 12-month period, with Kaplan-Meier estimates showing 82.3% of patients maintaining their response at one year. The study's findings were published in the February issue of The Journal of Urology. InvestingPro analysis shows the stock is currently trading near its 52-week low, with analyst price targets ranging from $22 to $64, suggesting significant upside potential. The stock appears undervalued based on InvestingPro's Fair Value analysis.
UGN-102 is an investigational drug using UroGen's proprietary RTGel technology, which allows for sustained exposure of bladder tissue to the therapeutic agent, mitomycin. This non-surgical treatment is administered via a urinary catheter by a healthcare professional in an outpatient setting.
The drug's safety profile remained consistent with previous studies, as most treatment-emergent adverse events were mild to moderate and either resolved or were resolving. Common adverse events included dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention.
UroGen has completed the submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for UGN-102, with the FDA accepting the NDA and setting a Prescription Drug User Fee Act (PDUFA) goal date of June 13, 2025.
The ENVISION trial's long-term results support the potential of UGN-102 to provide a significant advance in managing LG-IR-NMIBC, particularly for elderly patients who face the burden of repeated surgeries. This information is based on a press release statement from UroGen Pharma Ltd. The company maintains a strong financial position with a current ratio of 9.0, indicating robust liquidity. For deeper insights into UroGen's financial health and growth prospects, including 10+ additional ProTips and comprehensive valuation metrics, visit InvestingPro, where you'll find our detailed Pro Research Report covering what really matters about this promising biotech company.
In other recent news, UroGen Pharma Ltd. has reported substantial progress in its endeavors. The company's FDA-approved treatment, JELMYTO, shows sustained efficacy in treating low-grade upper tract urothelial cancer (LG-UTUC), according to data from the long-term OLYMPUS trial. The study highlighted JELMYTO's potential in managing the disease without immediate relapse, with a median duration of response of 47.8 months.
In addition, UroGen Pharma has been actively involved in the commercialization of JELMYTO and the development of UGN-102, a potential growth driver for the company upon approval. The company anticipates regulatory filings and decisions in the near future.
In their recent earnings call, UroGen Pharma discussed these developments and provided financial guidance for 2024. The company expressed confidence in its ongoing commercialization efforts for JELMYTO and optimism about the approval and commercial potential of UGN-102. These recent developments are part of UroGen Pharma's strategy to expand its commercialization efforts and advance its clinical trials.
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