March 29, 2016

AVEO Pharmaceuticals Inc. will pay $4 million to settle charges that it mislead investors about its efforts to obtain FDA approval for Tivozanib, its flagship developmental drug to treat kidney cancer.  The SEC alleges that AVEO concealed the FDA’s level of concern about Tivozanib in public statements to investors by omitting the critical fact that FDA staff had recommended a second clinical trial to address concerns about patient death rates during the first clinical trial.  When the FDA made public months later that it had recommended an additional clinical trial, the company’s stock price declined 31 percent.  AVEO never conducted an additional trial and the FDA later refused to approve Tivozanib.  The SEC also filed charges against AVEO’s former CEO, CFO, and CMO.  These charges remain outstanding.  SEC

Tagged in: Misrepresentations, Securities Fraud,