BioCryst Pharmaceuticals announced Friday that it has submitted a new drug application for its flu treatment Peramivir.
The move marks a remarkable turn in the drug’s fortunes in the U.S., where BioCryst has no drugs on the market.
Early this year, Durham-based BioCryst suspended development of Peramivir in the U.S. after inconclusive tests.
The suspension of work on Peramivir, along with BioCryst’s decision to withdraw what had been touted as a promising treatment for hepatitis C in response to concerns about the drug, caused the company’s stock to lose more than 70 percent of its value.
The setbacks also later led BioCryst and California-based Presidio Pharmaceuticals to cancel their proposed $101 million merger.
But in April BioCryst’s stock got a boost when it announced that federal regulators had outlined a path by which it could file a new drug application for Peramivir. BioCryst met with Food and Drug Administration officials in June and has now reached an agreement with regulators about the requirements for its application.
“BioCryst’s first NDA filing represents an important milestone in the history of the company,” CEO Jon Stonehouse said in a statement. “We are excited about the potential approval of peramivir as an IV treatment option that could benefit influenza patients in the United States.”
Stonehouse said BioCryst is preparing to make Peramivir available in the U.S. in time for the 2014-15 influenza season, “in the event approval is received in that time frame.”
The federal government had supplied $235 million to develop Peramivir, which rapidly delivers plasma to infection sites to inhibit the spread of influenza. It was approved in Japan and Korea in 2010.
BioCryst’s stock has risen more than 300 percent since June. Shares closed Friday at $6.92, down 4 cents.