Emergent BioSolutions says FDA has accepted its anthrax vaccine candidate for review

emergent-biosolutions-says-fda-has-accepted-its-anthrax-vaccine-candidate-for-review

Emergent BioSolutions Inc. EBS, +7.19% said Friday the U.S. Food and Drug Administration has accepted for review its application for approval of its anthrax vaccine. Dubbed AV7909, the vaccine is aimed at people aged 18 through 65 years who have been exposed to anthrax for use along with recommended antibacterial drugs. A decision is expected by April of 2023. “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,” said Kelly Warfield, Emergent senior vice president for R&D, in a statement. The company has submitted data from a phase 3 clinical trial of the vaccine, as well as from a phase 2 trial. Emergent shares were down 3% premarket and have fallen 26% in the year to date, while the s&P500 SPX, +0.95% has fallen 20%.

Source: Marketwatch

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