PRINCETON, N.J. - UroGen Pharma Ltd. (NASDAQ: URGN), a biotechnology firm focusing on urothelial and specialty cancers, has been granted a Notice of Allowance from the United States Patent and Trademark Office for its RTGel® technology combined with a mitomycin formulation. This patent covers UroGen's UGN-103 and UGN-104 programs, targeting treatment of specific low-grade urothelial cancers, and is set to last until December 2041.
The patent pertains to the use of RTGel® technology with a lyophilized mitomycin formulation licensed from medac, aimed at treating low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) and low-grade upper tract urothelial cancer (LG-UTUC). Liz Barrett, President and CEO of UroGen, expressed confidence that this combination could yield advantages in production, cost, supply, and patient convenience, underscoring the patent's strategic importance for the company's growth.
Earlier this year, UroGen entered a licensing and supply agreement with medac to develop UGN-103 and UGN-104. The FDA approved the investigational new drug (IND) application for UGN-103 in April 2024, with clinical site onboarding currently underway. A Phase 3 trial for UGN-104 is anticipated to begin in early 2025.
UGN-102, another UroGen product utilizing RTGel® technology, is in Phase 3 development for LG-IR-NMIBC and is designed for non-surgical tumor ablation. The company has completed its New Drug Application (NDA) submission for UGN-102 ahead of schedule in August 2024, with potential FDA approval expected in early 2025.
UroGen's RTGel® technology is a sustained-release hydrogel designed to prolong exposure of urinary tract tissue to medication, potentially enhancing treatment effectiveness. The company aims to advance care for patients with urothelial cancers through these innovative therapies.
This news is based on a press release statement and contains forward-looking statements regarding the potential benefits and approval timelines of UroGen's products. These statements carry risks and uncertainties, and there is no guarantee that the anticipated benefits will be realized or that regulatory approvals will be obtained as expected.
In other recent news, UroGen Pharma has seen significant developments. The company reported a notable 16% sequential increase and a 3% year-over-year growth in net product revenue for JELMYTO, reaching $21.8 million in Q2 2024. Additionally, UroGen Pharma raised approximately $116.2 million in a public offering to support the launch of UGN-102.
The company also announced the immediate resignation of board member Fred E. Cohen, M.D., D.Phil. His departure was not due to any disagreements with the company's operations, policies, or practices.
In relation to analyst remarks, H.C. Wainwright reaffirmed its Buy rating on UroGen Pharma with a steady price target of $60. This endorsement comes in light of UroGen's recent achievements and the potential market for UGN-102, which is estimated to exceed $5 billion annually.
UroGen Pharma has successfully submitted its New Drug Application (NDA) to the FDA for UGN-102, a treatment for non-muscle invasive bladder cancer. This submission follows promising results from the Phase 3 ENVISION trial, which reported a notable 12-month complete response rate of 82.3% in patients who had achieved a complete response at three months.
These are all recent developments that have occurred within the company.
InvestingPro Insights
As UroGen Pharma Ltd. (NASDAQ: URGN) progresses with its innovative RTGel® technology and related pharmaceutical programs, the company's financial health and market performance are key factors for investors to consider. According to InvestingPro data, UroGen holds a market capitalization of $563.49 million, and despite its pioneering efforts in urothelial cancer treatments, the company is not currently profitable, with a negative P/E ratio of -4.02. This is echoed in the last twelve months as of Q2 2024, where the adjusted P/E ratio worsens slightly to -4.88.
Nevertheless, there are positive indicators in the company's financials. UroGen boasts an impressive gross profit margin of 89.87%, reflecting efficient production and potentially strong market positioning for its products. This aligns with one of the InvestingPro Tips, which highlights the company's impressive gross profit margins. Moreover, UroGen's liquidity appears robust, with liquid assets surpassing short-term obligations, providing a cushion for ongoing research and development activities.
However, investors should be aware of the company's cash burn rate, which is another focal point in the InvestingPro Tips. The speed at which UroGen is utilizing its cash reserves could be a concern, especially as the company seeks to bring new treatments to market. Additionally, the company holds a high Price / Book multiple of 18.23, suggesting that the stock may be valued richly in relation to its net assets.
For those looking to delve deeper into UroGen's financials and future prospects, InvestingPro offers additional insights. There are currently 9 more InvestingPro Tips available for URGN at https://www.investing.com/pro/URGN, providing a comprehensive analysis that can help investors make informed decisions. These tips and data points can serve as a valuable resource for evaluating UroGen's potential as it navigates the complex landscape of biotechnology and pharmaceutical development.
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