WASHINGTON (AP) — Shares of Aveo Pharmaceuticals dipped Friday after the company disclosed that financial regulators issued a subpoena for documents related to its experimental kidney drug.
THE SPARK: Aveo said Thursday the Securities and Exchange Commission sent the company a subpoena for documents connected with the company’s drug tivozanib, including communications with federal regulators and investors. The company said the SEC indicated that “this inquiry should not be construed as an indication that any violations of law have occurred,” according to the company’s regulatory filing. Aveo added that it will not comment further on the issue.
THE BACKGROUND: Aveo said last month that the Food and Drug Administration had rejected approval for its drug, saying the clinical trial data supporting it was not clear.
The company said the FDA recommended it run a new clinical trial of tivozanib because it was not able to draw meaningful conclusions from a late-stage trial. That’s because of inconsistent survival data and differences in the kinds of therapies patients received after treatment in the study was complete.
In early May an FDA advisory panel said tivozanib shouldn’t be approved because the benefits of the pill didn’t justify its risks. Later Aveo’s partner Astellas Pharma decided not to file for marketing approval of the drug in Europe and said it wouldn’t fund any more studies of tivozanib as a treatment for renal cell carcinoma.
SHARE ACTION: Cambridge, Mass.-based Aveo Pharmaceuticals fell 8 cents, or 3.2 percent, to $2.46 in afternoon trading Friday after falling to an all-time low of $2.23 earlier in the day.
