PRINCETON, N.J. - UroGen Pharma Ltd. (NASDAQ: URGN) today announced results from its Phase 3 ENVISION trial, indicating a 12-month duration of response (DOR) of 82.3% in patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) who achieved a complete response after the initial treatment with UGN-102 (mitomycin) for intravesical solution.
The ENVISION trial met its primary endpoint with a 79.6% complete response rate at three months following the first instillation of UGN-102, a drug formulation utilizing UroGen's proprietary RTGel technology. The study included 108 patients, with the Kaplan-Meier estimate also showing DOR rates of 80.9% at both 15 and 18 months.
UGN-102 is being investigated as a potential non-surgical treatment option for patients with LG-IR-NMIBC, a disease that affects approximately 82,000 patients annually in the U.S. and is characterized by a high recurrence rate, often requiring multiple surgeries.
The treatment-emergent adverse events reported in the ENVISION trial were consistent with previous clinical trials, predominantly mild to moderate in severity, including dysuria, hematuria, and urinary tract infections.
UroGen initiated a rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for UGN-102 in January 2024 and plans to complete the process in the third quarter of 2024. If approved, UGN-102 could become the first FDA-approved non-surgical treatment option for LG-IR-NMIBC, with a potential FDA decision expected as early as the first quarter of 2025.
The company will host a virtual event today to discuss the trial results with a panel of bladder cancer experts. The event aims to provide insights into the clinical data and the potential impact of UGN-102 on LG-IR-NMIBC treatment.
The information in this article is based on a press release statement.
In other recent news, UroGen Pharma reported robust revenues of $18.8 million in the first quarter of 2024, primarily driven by sales of its treatment for low-grade upper tract urothelial cancer, JELMYTO. The company also announced the appointment of David Lin as its new Chief Commercial Officer, who is expected to lead the commercial strategy for the company's products. In addition, Oppenheimer reduced its price target for UroGen Pharma from $34 to $32, while maintaining an Outperform rating on the stock.
The company is preparing for the potential launch of UGN-102, their lead pipeline candidate for bladder cancer treatment, pending approval. UroGen Pharma's future developments include initiating clinical endpoint studies for UGN-103 and UGN-104, and advancing UGN-301 through Phase 1 clinical trials.
However, despite the promising pipeline and solid financial performance, UroGen Pharma reported a net loss of $32.3 million for the quarter. The company's management anticipates that the percentage of patients maintaining a complete response after a year could be in the mid-60s, drawing parallels to subgroup findings from the ATLAS study. The company's cash position remains strong at $164.5 million, with no immediate need for additional capital.
InvestingPro Insights
Following the promising results from UroGen Pharma's Phase 3 ENVISION trial, the financial metrics and expert analysis from InvestingPro offer additional insights into the company's standing. With a market capitalization of $462.47 million, UroGen Pharma holds a unique position in the biopharmaceutical space. Notably, the company's impressive gross profit margin of 89.53% in the last twelve months as of Q1 2024 underscores its ability to manage production costs effectively while developing its proprietary treatments.
Despite not being profitable over the last twelve months, with a negative P/E ratio of -3.92, the company's liquidity appears robust. An InvestingPro Tip highlights that UroGen Pharma holds more cash than debt on its balance sheet, which could provide the financial flexibility needed to navigate the upcoming regulatory milestones and potential market launch of UGN-102. Additionally, the company's liquid assets exceed short-term obligations, suggesting a strong short-term financial health that may reassure investors looking for stability in the volatile biotech sector.
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