SEC Comes Calling For Aveo As FDA Panel Fallout Continues

Xconomy Boston — 

The Aveo Oncology (NASDAQ: AVEO) saga took yet another turn today as the Securities and Exchange Commission has come knocking at the cancer drug maker’s door.

According to regulatory filings, the SEC has subpoenaed the Cambridge, MA-based biotech—the latest domino to fall since the company’s disastrous results before an FDA panel on May 2.

The filing says that last week, the SEC asked Aveo for “documents and information” regarding tivozanib, the cancer drug shot down by an advisory panel in May and later rejected by the FDA.

“The SEC has informed the company that this inquiry should not be construed as an indication that any violations of law have occurred or that the SEC has any negative opinion of any person, entity or security,” Aveo said in the filing.

Aveo won’t comment any further on the matter until it is closed, or the SEC takes further action.

The advisory panel in May voted overwhelmingly that Aveo should have to run another trial before winning approval as a kidney cancer treatment and was highly critical of its trial design. FDA oncology chief Richard Pazdur thrashed the company in the process, criticizing the fact that patients taking another drug—sorafenib (Nexavar)—lived longer than those taking Aveo’s drug during a head-to-head late-stage trial.

Aveo’s stock has plummeted since then. The company also cut 62 percent of its workforce, and partner Astellas Pharma has bailed on tivozanib as a kidney cancer drug (the two are still partners on its potential use in breast and colorectal cancer).