BioCryst Flat After FDA Nod

BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) shares dropped off a bit Thursday after the company disclosed that its RAPIVAB received approval from the U.S. Food and Drug Administration for a pediatric injection.

The company, located in Research Triangle Park, North Carolina is focused on the development and commercialization of treatments for rare and infectious diseases, said the FDA approved a supplemental New Drug Application for RAPIVAB (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor, extending its availability for the treatment of acute uncomplicated influenza to pediatric patients two years and older who have been symptomatic for no more than two days. The pediatric approval was based on the interim analysis of an ongoing pediatric clinical study.

Those results will be presented at the upcoming ID Week 2017 meeting in San Diego.

Said CEO Jon Stonehouse, “This approval represents the first new influenza antiviral for pediatric use in over 10 years. RAPIVAB provides another treatment option for pediatric patients with acute, uncomplicated influenza and represents another important milestone for BioCryst.”

RAPIVAB®, a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Japan, Taiwan and Korea. Post-marketing commitment development activities for RAPIVAB are ongoing, as well as activities to support regulatory approvals in other territories

Shares tailed off as the clock approached noon Thursday by five cents to $5.22, within a 52-week trading range of $3.75 to $9.25.