Novavax (NVAX) said Wednesday it believes its biologics license application for its COVID-19 vaccine is "approvable" by the US Food and Drug Administration based on ongoing discussions.
The company said the FDA recently asked for a post-marketing commitment to collect additional clinical data.
Novavax said it will work quickly to comply with the request and obtain final approval.
Shares of Novavax rose 12% in recent premarket activity Wednesday.