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Aveo Subpoenaed by U.S. Regulator Over Kidney Cancer Drug

Aveo Pharmaceuticals Inc. (AVEO) said it received a subpoena from U.S. regulators for documents on its experimental kidney cancer drug that was rejected for approval last month. The shares fell 14 percent in extended trading.

The Securities and Exchange Commission asked for documents and information concerning tivozanib, including communications with the Food and Drug Administration, Cambridge, Massachusetts-based Aveo said today in a filing. The company on June 10 said the FDA wouldn’t approve the drug for advanced kidney cancer because of inconsistent clinical trial results.

An FDA advisory panel had recommended against the medicine’s approval in May and Aveo on June 4 said it would cut about 62 percent of its workforce in a restructuring meant to save $190 million over the next two years.

“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 fell to $2.18 at 5:11 p.m. New York time after gaining 2 percent to close at $2.54. The shares have declined 69 percent this year.

Aveo was developing tivozanib in a partnership with Tokyo-based Astellas Pharma Inc. (4503) It has abandoned work on the drug in kidney cancer and will focus on breast and colon cancer, as well as on the development of earlier-stage compounds, the company said in June. Aveo said it was cooperating with the SEC’s request.

To contact the reporter on this story: Elizabeth Lopatto in San Francisco at elopatto@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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