PRINCETON, N.J. - UroGen Pharma Ltd. (NASDAQ: URGN) has received the green light from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 3 clinical trial for its investigational drug UGN-103. The trial, which is set to begin in 2024, will assess the safety and efficacy of UGN-103 as a treatment for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
UGN-103 is a novel formulation of mitomycin that leverages UroGen's proprietary RTGel® technology. This reverse-thermal hydrogel aims to provide sustained drug release, potentially improving treatment outcomes for patients with LG-IR-NMIBC, a condition known for its high recurrence rate.
"We are delighted by the FDA's acceptance of our IND for UGN-103, marking a significant step forward in our mission," stated Liz Barrett, President and CEO of UroGen. The company is eager to commence the Phase 3 study within this year, as it continues to focus on addressing high unmet medical needs.
UGN-103's anticipated benefits include a new 80 mg mitomycin dosage strength, which may significantly reduce manufacturing time, streamline the reconstitution process, and could extend the drug's intellectual property protection until December 2041, if approved.
The upcoming Phase 3 study of UGN-103 follows UroGen's ongoing development of UGN-102, another mitomycin-based treatment for LG-IR-NMIBC. UroGen plans to complete the rolling submission of a New Drug Application (NDA) for UGN-102 in September 2024. If granted priority review, the FDA's decision could arrive as early as the first quarter of 2025.
UGN-102, currently in Phase 3 development, utilizes the same RTGel® technology to allow for prolonged exposure of bladder tissue to mitomycin, potentially enabling non-surgical tumor treatment. The company anticipates submitting an NDA for UGN-102, contingent on positive results from the ENVISION Phase 3 study's durability of response endpoint.
UroGen Pharma is a biotech firm dedicated to developing innovative treatments for urothelial and specialty cancers. Its RTGel® technology is designed to enhance the efficacy of existing drugs by allowing for longer exposure to the urinary tract.
This article is based on a press release statement from UroGen Pharma Ltd.
InvestingPro Insights
As UroGen Pharma Ltd. (NASDAQ: URGN) gears up for its Phase 3 clinical trial of UGN-103, investors are closely monitoring the company's financial health and market performance. An analysis of UroGen's recent financial data reveals some key insights:
The company's gross profit margin has been notably high, reaching 88.68% in the last twelve months as of Q4 2023, reflecting its impressive ability to control the costs associated with its goods sold. This margin is indicative of a strong potential for profitability once revenue scales with the commercialization of its products.
InvestingPro Tips for UroGen also highlight that the Relative Strength Index (RSI) suggests URGN stock is currently in oversold territory, which could signal an upcoming rebound in its share price for attentive investors. Additionally, it's important to note that UroGen has a solid liquidity position, with liquid assets that exceed its short-term obligations, offering some financial flexibility as it advances its clinical trials.
On the flip side, analysts have flagged concerns, noting that three analysts have revised their earnings forecasts downwards for the upcoming period. Moreover, there is a consensus that the company may not achieve profitability this year. This aligns with the company's operating income margin, which was deeply negative at -79.23% in the last twelve months as of Q4 2023, underscoring the costs associated with its research and development efforts.
For investors seeking a more comprehensive analysis, there are additional InvestingPro Tips available on the platform. By using the coupon code PRONEWS24, readers can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, which includes a total of 9 InvestingPro Tips for UroGen, providing a deeper dive into the company's financial metrics and market positioning.
As of the latest data, UroGen's market cap stands at $515.24 million USD, indicating the market's current valuation of the company. The price of the stock at the previous close was $13.25 USD, which is 54.75% of its 52-week high, reflecting recent market movements and investor sentiment.
With the next earnings date scheduled for May 9, 2024, investors and stakeholders will be keenly awaiting updates on the company's financial performance and the progress of its clinical trials.
For those interested in a detailed investment analysis, visit https://www.investing.com/pro/URGN to explore the full range of InvestingPro Tips and metrics for UroGen Pharma Ltd.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.