Violation Tracker Individual Record

Company: 
AVEO Pharmaceuticals Inc.
Current Parent Company: 
AVEO Pharmaceuticals
Penalty: 
$4,000,000
Year: 
2016
Date: 
March 29, 2016
Offense Group: 
financial offenses
Primary Offense: 
investor protection violation
Violation Description: 

The SEC announced fraud charges against a Massachusetts-based biotech company and three former executives for misleading investors about the company's efforts to obtain Food and Drug Administration approval for its flagship developmental drug to treat kidney cancer. The SEC alleged that AVEO Pharmaceuticals Inc. 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 their 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.

Level of Government: 
federal
Action Type: 
agency action
Agency: 
Securities and Exchange Commission
Civil or Criminal Case: 
civil
HQ Country of Parent: 
USA
HQ State of Parent: 
Massachusetts
Ownership Structure of Parent: 
publicly traded
Major Industry of Parent: 
pharmaceuticals
Specific Industry of Parent: 
biopharmaceuticals
Source Notes: 
If an online information source is not working, check the Violation Tracker Data Sources page for an updated link.
Parent company note: 
Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.