Unlikely Bedfellows: SEC Penalties When Industry Fails to Disclose FDA Recommendations for Clinical Trials

By Thomas Sullivan Last updated May 5, 2018

In a unique case, the U.S. Securities and Exchange Commission (SEC) recently announced a significant settlement with AVEO Pharmaceuticals for failing to disclose publicly as part of its quarterly financial filings that the FDA had recommended a second round of clinical trials for kidney cancer drug, Tivozanib, as part of the drug approval process. This case represents a new chapter in SEC regulatory oversight involving the life sciences industry when there are omissions, failure to disclose, and other transparency issues involving a company’s SEC filings.

On March 29, 2016, the SEC publicly announced fraud charges against the Massachusetts-based biotech company Aveo and three of its former executives for misleading investors about the company’s efforts to obtain Food and Drug Administration (FDA) approval for its flagship developmental drug Tivozanib, which is intended to treat kidney cancer.