ArQule, Inc. and Daiichi Sankyo, Inc. Reach Agreement With FDA on Special Protocol Assessment for Phase 3 Trial of Tivantinib in Hepatocellular Carcinoma

WOBURN, Mass.--(BUSINESS WIRE)--ArQule, Inc. (Nasdaq: ARQL) today announced a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the design of a pivotal Phase 3 trial of tivantinib in patients with hepatocellular carcinoma (HCC).