EBS - Emergent announces FDA acceptance of marketing application for anthrax vaccine

Emergent BioSolutions (NYSE:EBS) announced on Friday that the FDA accepted its Biologics License Application (BLA) for the investigational anthrax vaccine AV7909 with a Prescription Drug User Fee Act goal date in April 2023 for review. The company has developed AV7909 for post-exposure prophylaxis when exposed to the causative agent Bacillus anthracis bacterium in people aged 18 – 65 years when administered in combination with recommended antibacterial drugs. Emergent (EBS) developed AV7909 in partnership with Biomedical Advanced Research and Development Authority (BARDA), a unit of the U.S. Department of Health and Human Services. The rolling submission of BLA was completed in April based on data a pivotal phase 3 clinical study that was designed to evaluate a intramuscularly-administered two-dose schedule in healthy adults. Read: Why Seeking Alpha contributor thinks Emergent (EBS) is a top pick for the ongoing monkeypox outbreak.

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Emergent announces FDA acceptance of marketing application for anthrax vaccine