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.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.