The U.S. Food and Drug Administration (FDA) has accepted to review Emergent BioSolutions’ (NYSE:EBS) Biologics License Application (BLA) for its new anthrax vaccine candidate AV7909.
The regulatory agency sets the Prescription Drug User Fee Act (PDUFA) goal date for a decision in month of April 2023.
The Biologics License Application (BLA) is supported by data readout from the pivotal phase 3 clinical study of AV7909 that evaluated the lot consistency, immunogenicity, and safety of the vaccine candidate.
Kelly Warfield, senior vice president research and development, commented : “As we progress toward licensure of AV7909, which is designed to follow a two-dose immunization schedule and to elicit a faster immune response, we redouble our efforts to support the government's overall preparedness and response strategy for large-scale emergencies involving anthrax and other threats to public health.”
Emergent BioSolutions Shares are trading at $31.97 in the regular market session.
