UroGen Pharma Ltd (NASDAQ:URGN) shares are surging after the company released topline data from its Phase 3 trials ATLAS and ENVISION studying UGN-102 (mitomycin) for intravesical solution in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
Both ATLAS and ENVISION trials met their primary endpoints.
In the ATLAS trial, UGN-102 met its primary endpoint of disease-free survival, reducing the risk of recurrence, progression, or death by 55%.
UGN-102 also showed a 64.8% complete response rate at three months for patients who only received UGN-102, compared to a 63.6% complete response rate at three months for patients who only received a TURBT, a standard treatment for bladder cancer.
The ENVISION trial met its primary endpoint by demonstrating that patients treated with UGN-102 had a 79.2% rate of complete response at 3 months following the initial treatment.
Additional data evaluating the secondary endpoint of the duration of response from ENVISION and the submission of a New Drug Application (NDA) (assuming additional positive findings) to the FDA are anticipated in 2024.
UGN-102 was generally well tolerated in both trials, with a side effect profile similar to previous clinical trials.
Concurrently, UroGen announced a private placement of approximately $120 million.
Price Action: URGN shares are up 42.70% at $12.86 on the last check Thursday
