AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) shares slumped on Thursday dropping 59% post market. The stock continued to decline losing 5.21% in the last trading session to end the day at $0.59 per share.

The reason behind the decline in stock is the announcement that the company made that they had received a pushback from the FDA for approval of FOTIVDA.  On Thursday the company announced that following the FDA recommendations they will not submit the marketing application for FOTIVDA in treatment of renal cell carcinoma.

Set back in development of tivozanib

The FDA recommended that the company need to have more mature OS results from their third phase TIVO-3 trial. The company arrived at the decision not to submit the NDA since the preliminary overall survival data did not dispel the concerns over the potential adverse effects cited in the complete response letter of 2013.

The company has struggled to get approval for their tivozanib drug for treatment in kidney cancer in the United States in the past five years. As a result the valuation of the company has dropped in valuation to almost $109 million.  Currently the dug has approval in the European Union Iceland and Norway for treatment of kidney cancer. 

The FDA indicated that there was lack of clarity on outcomes of the initial study in 2013 when the drug demonstrated that it could halt kidney cancer for three more months than Nexavar but the patients treated with tivozanib died earlier than others.

Scheduled NDA filing

Following the availability of more mature overall survival results the company is planning to make a decision on the NDA filing. In November last year the company disclosed preliminary result in the third phase TIVO-3 study which demonstrated a hazard ration of greater than one.

Initially AVEO had planned to have the final OS analysis by August but because of longer median OS for both arms they have decided to designate them as interim. The company expects to release the results of the analysis in the fourth quarter.

They will present the detailed results of the third phase TIVO-3 study during the ASCO GU symposium in San Francisco on February 14, 2019.

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