BioCryst Reports Filing for Peramivir NDA Supported by BARDA/HHS Funding
BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) today announced that the Biomedical Advanced Research and Development Authority (BARDA/HHS) has released funding under the current $234.8 million contract to enable completion of a New Drug Application (NDA) filing for intravenous (i.v.) peramivir. BioCryst is seeking an indication for the treatment of acute uncomplicated influenza and expects to submit the peramivir NDA by the end of 2013.
On June 28, BioCryst completed a pre-NDA meeting with the FDA regarding peramivir. BioCryst reached agreement with FDA regarding all requirements for a complete NDA submission.
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