Durham drug developer BioCryst Pharmaceuticals said Tuesday that federal regulators have accepted the companys Peramivir flu treatment for safety review, keeping the medication on track for introduction in the United States for the 2014-15 flu season.
Peramivir has been under development since 2007 with $235 million in federal funding but was withdrawn from federal review last year after inconclusive tests. That setback tanked BioCrysts stock and sank a planned merger.
Since BioCryst announced it planned to revive Peramivir, the companys stock has soared. After reaching a low of $1.19 a share last March, the stock rose 10 percent Tuesday to close at $12.83, the highest its been since the summer of 2006.
BioCryst said Peramivir has been tested on more than 2,700 patients in 27 clinical trials. Its been approved in Japan and Korea. The 38-employee company has no products on the market in the United States.
Peramivir is an intravenously administered antiviral agent that delivers high plasma doses to infected areas. If approved, it would be the first IV antiviral in the United States.
The drug was discovered by BioCryst and inhibits a flu enzyme that enables flu to spread in an infected person. BioCryst said that lab tests showed Peramivir to be effective against multiple flu strains, including H1N1 swine flu.
Staff writer John Murawski