When news broke that the U.S. Food and Drug Administration may delay its approval of Aveo Pharmaceuticals' (NASDAQ:AVEO) new drug tivozanib, the company's small cap stock fell sharply, and struggled to gain ground for the rest of mid-day trading.
According to Market Pulse, the FDA announced on Thursday that it had concerns over bits of data in the product's clinical trial. To appease the federal regulators, Aveo said it would submit further analyses and more detailed accounts of the trials, however this could push the approval process back into the fourth quarter of 2012.
The Cambridge, Massachusetts – based company saw early trial success with the drug, which is being developed to treat kidney cancer, however the new questions may negate the positive findings.
"Aveo is conducting additional analyses to be included in the New Drug Application submission that demonstrate that the overall survival data from TIVO-1 are consistent with improved clinical outcomes in renal cell carcinoma patients receiving more than one line of therapy; analyses that the company believes will directly address this issue," the company said.
As of 1:32 p.m. on Thursday, August 2, Aveo stock was down 28.3 percent to $9.54.