UroGen Pharma (URGN, Financial) has announced promising findings from a long-term follow-up study of its FDA-approved treatment, JELMYTO, for low-grade upper tract urothelial cancer (LG-UTUC) in adults. Data reveals that among patients who achieved a complete response in the OLYMPUS trial using JELMYTO, the median duration of response was approximately 47.8 months.
The study included patients with both new-onset and recurrent upper tract urothelial cancer. In this cohort, 21 patients had new-onset cancer while 20 had recurrent cancer at the start of the study. Importantly, the study found no significant difference in treatment durability between these groups, as eight patients from each experienced either cancer recurrence or death unrelated to the treatment.
Additionally, a subset of 20 patients entered an extended follow-up phase of the study, with a median follow-up period of 53.3 months. However, due to the low event rate, a median duration of response could not be established for this group.
Wall Street Analysts Forecast
Based on the one-year price targets offered by 8 analysts, the average target price for UroGen Pharma Ltd (URGN, Financial) is $32.63 with a high estimate of $55.00 and a low estimate of $16.00. The average target implies an upside of 230.55% from the current price of $9.87. More detailed estimate data can be found on the UroGen Pharma Ltd (URGN) Forecast page.
Based on the consensus recommendation from 8 brokerage firms, UroGen Pharma Ltd's (URGN, Financial) average brokerage recommendation is currently 1.8, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
Based on GuruFocus estimates, the estimated GF Value for UroGen Pharma Ltd (URGN, Financial) in one year is $9.16, suggesting a downside of 7.19% from the current price of $9.87. GF Value is GuruFocus' estimate of the fair value that the stock should be traded at. It is calculated based on the historical multiples the stock has traded at previously, as well as past business growth and the future estimates of the business' performance. More detailed data can be found on the UroGen Pharma Ltd (URGN) Summary page.
URGN Key Business Developments
Release Date: March 10, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- UroGen Pharma Ltd (URGN, Financial) submitted a new drug application for UGN 102 ahead of schedule, with FDA review underway and a target date set for June 13th.
- The Envision phase 3 trial for UGN 102 demonstrated a compelling complete response rate of 79.6% at 3 months and an 82.3% duration of response at 12 months.
- UroGen Pharma Ltd (URGN) reported a strong balance sheet with $241.7 million in cash equivalents and marketable securities, positioning them well for future growth.
- The company achieved a 12% year-over-year increase in sales for their commercial product, Jelmyto, indicating strong market demand.
- UroGen Pharma Ltd (URGN) is expanding its sales force from 52 to 83 representatives in anticipation of the UGN 102 launch, demonstrating a commitment to commercial preparedness.
Negative Points
- UroGen Pharma Ltd (URGN) reported a net loss of $126.9 million for the full year 2024, an increase from the $102.2 million loss in 2023.
- Research and development expenses increased significantly to $57.1 million in 2024 from $45.6 million in 2023, driven by manufacturing and regulatory expenses.
- SG&A expenses rose to $121.2 million in 2024 from $93.3 million in 2023, primarily due to commercial preparation activities for UGN 102.
- The company anticipates using a miscellaneous J code for UGN 102 initially, which may complicate reimbursement processes for providers.
- UroGen Pharma Ltd (URGN) faces potential challenges in market access and reimbursement during the initial launch period of UGN 102 due to the generic J code.
