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BioWorld - Monday, July 6, 2026
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Home » FDA tells Aveo to wait on tivozanib NDA filing
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FDA tells Aveo to wait on tivozanib NDA filing

Nov. 5, 2019
By Michael Fitzhugh
Shares in Aveo Pharmaceutical Inc. (NASDAQ:AVEO), commonly called Aveo Oncology, fell 36.7% Monday to 57 cents after the FDA dashed hopes that positive interim data from a late-stage study of tivozanib would overcome agency concerns about the drug's efficacy in relapsed/refractory renal cell carcinoma (RCC). Advised by the regulator not to submit an NDA at this time, Aveo now plans to collect more mature data ahead of filing its NDA in the first quarter of 2020. A discussion with the FDA's Oncologic Drug Advisory Committee will likely be required too, the agency said.
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