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News Breaks | | | | October 16, 2012 | | 08:01 EDT |  | ARQL | ArQule, Daiichi Sankyo reach agreement with FDA on SPA for Phase 3 trial
ArQule announced a Special Protocol Assessment agreement with the U.S. Food and Drug Administration for the design of a pivotal Phase 3 trial of tivantinib in patients with hepatocellular carcinoma. The Phase 3 trial will be a randomized, double-blinded study of tivantinib as single agent therapy in previously treated patients with MET diagnostic-high inoperable HCC. The primary endpoint is overall survival in the intent-to-treat population, and the secondary endpoint is progression free survival in the same population. Approximately 300 patients are planned to be enrolled at approximately 120 centers worldwide. | |
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News For ARQL From The Last 14 Days Check below for free stories on ARQL the last two weeks. |
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| May 8, 2013 | | 07:02 EDT |  | ARQL | ArQule reports Q1 EPS (9c), consensus (11c)
Reports Q1 revenue $5.66M, consensus $3.78M. | |
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