The U.S. Food and Drug Administration (FDA) has accepted to review Emergent BioSolutions’ 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.
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