BioCryst has funding to complete new drug application
DURHAM – BioCryst Pharmaceuticals Inc. said Thursday that it will have the money to complete a new drug application for its intravenous influenza treatment candidate.
The company announced that the Biomedical Advanced Research and Development Authority, a division of the U.S. Department of Health and Human Services, will release funding under the company’s $234.8 million contract to allow completion of the filing.
BioCryst is seeking an indication for the candidate for the treatment of acute uncomplicated influenza. It expects to submit an application for peramivir by the end of the year, according to a news release. The anti-viral candidate was designed to stop the spread of the flu virus in the host.
Last year, BioCryst suspended enrollment in a clinical trial for the candidate after an independent analysis of testing the drug in patients in the hospital with serious flu found the drug was “trending toward futility.”
The company got a stop-work order for peramivir from the U.S. Department of Health and Human Services except for certain activities primarily related to an upcoming meeting with the FDA.