2023-07-27 10:43:35 ET
UroGen Pharma ( NASDAQ: URGN ) announced Thursday that its lead product candidate, UGN-102, reached primary endpoints in two Phase 3 trials for patients with bladder cancer.
The ATLAS and ENVISION trials were designed to evaluate UGN-102 in over 500 patients with low-grade, intermediate-risk non-muscle invasive bladder cancer.
After a brief trading halt, UroGen ( URGN ) surged ~41% intraday following the announcement.
Citing topline data, UroGen ( URGN ) said the ATLAS trial, which evaluated UGN-102 with or without standard of care TURBT vs. TURBT alone, met its primary endpoint, indicating a 55% reduction in the risk of recurrence, progression, or death.
According to the readout, the patients who received only UGN-102 and TURBT recorded 64.8% and 63.6% complete response rates at three months, respectively.
The single-arm ENVISION trial also reached its main goal, as patients on UGN-102 achieved a 79.2% complete remission at 3 months following the dosing initiation.
In both studies, UGN-102, which is a formulation of chemotherapy mitomycin, was generally well tolerated with a side effect profile consistent with its previous trials, UroGen ( URGN ) said.
The company intends to submit a marketing application for UGN-102 next year, subject to positive data from the ENVISION trial on the treatment’s duration of response.
Concurrently, UroGen ( URGN ) announced a $120M a private placement from a group of investors led by RA Capital Management L.P. and Great Point Partners LLC on Thursday. As part of the transaction, the company intends to issue 12.6M shares or warrants at $9.54 apiece.
The company intends to use the proceeds on operational activities, including R&D and commercialization. The deal is expected to close on Friday.
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UroGen says bladder cancer therapy met main goals in Phase 3 trials