UroGen Pharma Ltd. (NASDAQ: URGN) stock saw a notable uptrend of 37.58% to close the previous session at $17.50 after disclosing positive clinical trial findings. UroGen shared that based on Kaplan-Meier projections from its Phase 3 ENVISION study, 82.3% of patients sustained a 12-month duration of response (DOR).
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In this experiment, patients who experienced a complete response (CR) three months following the first intravesical solution delivery of the investigational medication UGN-102 (mitomycin) were assessed. Previously, the ENVISION trial met its primary endpoint by showing that 79.6% of patients had a CR at three months post-first instillation of UGN-102.
Detailed Analysis Of The ENVISION Phase 3 Study
With a three-month CR rate of 79.6% and a 12-month DOR of 82.3%, these data highlight the strong clinical profile of UGN-102 and increase its potential to become the first FDA-approved non-surgical therapy for LG-IR-NMIBC. UroGen estimates that 82,000 patients in the United States suffer from this recurrent disease annually, highlighting the need for innovative treatment approaches.
Safety Profile And Future Prospects
The ENVISION study revealed that the most frequently occurring treatment-emergent adverse events (TEAEs) were, on average, mild to severe in severity and comprised dysuria, hematuria, urinary tract infection, pollakiuria, tiredness, and urine retention. The safety profile seen in the ENVISION study matched that of earlier UGN-102 research.
These encouraging DOR results support UGN-102’s potential as a non-surgical substitute for the existing standard of therapy, which frequently entails many procedures that may have a negative impact on patients’ physical well-being and quality of life.
UroGen started submitting a New Drug Application (NDA) on a rolling basis to the FDA in January 2024 in order to treat LG-IR-NMIBC with UGN-102. UroGen intends to finish the UGN-102 NDA by the third quarter of 2024, and the most recent DOR data is likely to support it. It is expected that the FDA will make a decision, maybe in the first quarter of 2025.
