PRINCETON, N.J. - UroGen Pharma Ltd. (NASDAQ: URGN) announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for UGN-102 (mitomycin) for intravesical solution, a potential treatment for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The company reports that UGN-102 could be the first FDA-approved medicine for this condition, with a Prescription Drug User Fee Act (PDUFA) goal date set for June 13, 2025.
Liz Barrett, President and CEO of UroGen, expressed the significance of the FDA's acceptance as a critical step in making UGN-102 available to patients. The drug's potential to offer a new treatment option and meet unmet needs in LG-IR-NMIBC was emphasized, with the company preparing for a potential 2025 launch.
Dr. Mark Schoenberg, UroGen's Chief Medical Officer, highlighted the robust data supporting the NDA, including results from the ENVISION trial. The trial showed a 79.6% complete response rate at three months post-first instillation and an 82.3% 12-month duration of response in patients who achieved a complete response at 3 months. Common adverse events were dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention, with a safety profile consistent across studies.
UGN-102 utilizes UroGen's proprietary RTGel technology, aiming to allow prolonged bladder tissue exposure to mitomycin and non-surgical tumor treatment. Administered via a standard urinary catheter by healthcare professionals, UGN-102 is currently under FDA review, with a market potential estimated at approximately $5 billion in the U.S. if approved.
The ENVISION trial, a Phase 3 study, evaluated UGN-102 as a primary chemoablative therapy for LG-IR-NMIBC patients. The trial met its enrollment target with around 240 patients across 56 sites. The primary endpoint was the complete response (CR) rate at three months, with a secondary focus on durability in patients achieving a CR.
In the U.S., bladder cancer ranks as the second most common urologic cancer in men, with LG-IR-NMIBC accounting for about 22,000 new cases and 60,000 annual recurrences. The median age at diagnosis is 73 years, with a high recurrence risk and repeated procedures for many patients.
UroGen Pharma focuses on developing solutions for urothelial and specialty cancers, leveraging its RTGel technology to potentially improve existing drug therapies. The company is headquartered in Princeton, NJ, with operations in Israel. This article is based on a press release statement.
In other recent news, UroGen Pharma has seen a series of significant developments. The company reported a 16% sequential increase and a 3% year-on-year growth in net product revenue for JELMYTO, totaling $21.8 million. UroGen has successfully completed its New Drug Application for UGN-102 and expects potential FDA approval in early 2025. To support the launch of UGN-102, the company secured a $25 million loan and raised approximately $116.2 million in a public offering.
UroGen Pharma also announced the appointment of Chris Degnan as the new CFO, following the departure of Don Kim. Degnan brings significant experience from his previous roles at Galera Therapeutics (OTC:GRTX) and Verrica Pharmaceuticals (NASDAQ:VRCA). H.C. Wainwright maintained a Buy rating for UroGen Pharma, citing these developments as part of their affirmation.
Analysts from EF Hutton initiated coverage on UroGen Pharma with a Buy rating, focusing on the potential growth from new products UGN102 and UGN103. UroGen Pharma has also been granted a US patent for its RTGel® technology combined with a mitomycin formulation, set to last until December 2041. Lastly, Fred E. Cohen, M.D., D.Phil., a board member of UroGen Pharma, has resigned from his position.
InvestingPro Insights
As UroGen Pharma Ltd. (NASDAQ: URGN) awaits the FDA's decision on UGN-102, investors may find value in examining the company's financial health and market position. According to InvestingPro data, UroGen's market capitalization stands at $516.32 million, reflecting the market's current valuation of the company's potential.
The company's revenue growth of 17.22% over the last twelve months as of Q2 2024 indicates positive momentum, which aligns with the promising developments in its product pipeline. This growth is particularly significant given the potential $5 billion market for UGN-102 in the U.S., should it receive FDA approval.
InvestingPro Tips highlight UroGen's impressive gross profit margins, which stand at 89.87% for the last twelve months as of Q2 2024. This high margin suggests efficient cost management and could provide financial flexibility as the company prepares for a potential product launch in 2025.
However, investors should note that UroGen is currently not profitable, with an operating income margin of -93.15% over the same period. An InvestingPro Tip also points out that the company is quickly burning through cash, which is a common characteristic of biotech firms in the development stage.
On a positive note, UroGen holds more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations. These factors could be crucial in supporting the company's operations and potential commercialization efforts for UGN-102.
For investors considering UroGen's stock, it's worth noting that the company is trading at a high Price / Book multiple of 17.03, which may reflect market optimism about its future prospects. The stock's current price is 59.08% of its 52-week high, potentially indicating room for growth if clinical and regulatory milestones are met.
Investors seeking a more comprehensive analysis can access additional insights through InvestingPro, which offers 8 more tips for UroGen Pharma Ltd.
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