CSL, Arcturus Therapeutics announce European Commission approval for Kostaive

CSL (CSLLY) and Arcturus Therapeutics (ARCT) announced that the European Commission has granted marketing authorization for Kostaive, a self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. Kostaive is the first sa-mRNA COVID-19 vaccine to receive approval from the European Commission. Kostaive is currently marketed in Japan against COVID-19. The European Commission approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use of the European Medicines Agency on December 12, 2024. The centralized marketing authorization of Kostaive is valid in all EU member states and in the EEA countries.