PRINCETON - UroGen Pharma Ltd. (NASDAQ:URGN), a biotechnology firm focused on developing treatments for urothelial cancers, announced the completion of its New Drug Application (NDA) to the U.S. Food and Drug Administration for UGN-102, a therapy for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The company is aiming for FDA approval in early 2025, pending acceptance and priority review of the NDA.
UGN-102, utilizing the company's proprietary RTGel technology, is designed to allow longer exposure of bladder tissue to mitomycin, potentially treating tumors non-surgically. The drug is administered through a urinary catheter in an outpatient setting.
The NDA is backed by data from the Phase 3 ENVISION trial, which met its primary endpoint. A 79.6% complete response rate was observed at three months post-treatment, with a 12-month duration of response of 82.3% in patients who achieved a complete response, based on Kaplan-Meier estimates. The ENVISION trial also reported safety profiles consistent with previous studies, with most treatment-emergent adverse events being mild-to-moderate and resolving over time.
In the United States, LG-IR-NMIBC accounts for about 22,000 new patients annually and 60,000 recurrences among previously diagnosed patients. The current standard of care involves transurethral resection of bladder tumor (TURBT), but up to 70% of patients may experience recurrence, leading to repeated procedures.
Liz Barrett, President and CEO of UroGen, emphasized the urgent need for innovative therapies like UGN-102, which could offer patients quality of life benefits and clinically meaningful recurrence-free intervals if approved.
This announcement is based on a press release statement from UroGen Pharma Ltd. The information provided is subject to the standard risks and uncertainties of drug development and regulatory approval processes. The company's forward-looking statements are predictions based on current expectations and involve risks that could cause actual results to differ.
In other recent news, UroGen Pharma has reported promising results in its Q2 2024 Earnings Call, particularly regarding its bladder cancer treatment, UGN-102. The company announced positive 12-month data from the ENVISION study, showing a high complete response rate and is preparing for regulatory submission. UroGen Pharma experienced growth in net product revenue for JELMYTO and successfully raised substantial funds in a public offering.
The company plans to submit an NDA for UGN-102 soon, expecting an FDA decision in Q1 2025. The Q2 2024 net product revenue for JELMYTO was $21.8 million, marking a 16% sequential increase and a 3% year-over-year growth. Furthermore, the company raised approximately $116.2 million in a public offering to support UGN-102's launch.
UroGen is preparing for the commercial launch of UGN-102 in early 2025. The company is also progressing with Phase 3 clinical trials for UGN-103 and UGN-104. Despite facing challenges with JELMYTO's adoption and patient identification, UroGen remains optimistic about the commercial potential of UGN-102 and JELMYTO.
InvestingPro Insights
As UroGen Pharma Ltd. (NASDAQ:URGN) gears up for a potentially transformative period with its UGN-102 therapy, the financial metrics provided by InvestingPro paint a detailed picture of the company's current market standing. With a market capitalization of $615.9 million, UroGen Pharma is navigating the biotech landscape with a focus on solidifying its financial footing.
An impressive gross profit margin of 89.53% over the last twelve months as of Q1 2024 reflects the company's ability to manage its cost of goods sold effectively, a crucial factor as it invests in the development of UGN-102.
InvestingPro Tips highlight that UroGen Pharma holds more cash than debt on its balance sheet, suggesting a stable financial position that could support ongoing research and development efforts. Moreover, two analysts have revised their earnings upwards for the upcoming period, indicating potential optimism surrounding the company's financial prospects.
However, it is important to note that analysts do not anticipate the company will be profitable this year, and UroGen has not been profitable over the last twelve months. This context is essential for investors considering the inherent risks and long-term potential of biotech investments.
Furthermore, the company's stock has experienced a strong return over the last three months, with a 15.34% increase, reflecting positive sentiment in the market. This could be attributed to the promising clinical trial results and the subsequent submission of the NDA for UGN-102. While UroGen does not pay a dividend to shareholders, the company's focus on growth and development may appeal to investors looking for capital appreciation opportunities.
For those interested in a deeper dive into UroGen Pharma's performance and future outlook, InvestingPro offers additional tips, providing a comprehensive analysis for informed investment decisions. Visit https://www.investing.com/pro/URGN for more insights.
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