The FDA approves Emergent BioSolutions' sBLA seeking a label expansion of ACAM2000 for the mpox indication. Stock rises in pre-market trading.
Shares of Emergent BioSolutions were charging higher after the vaccine maker announced the Food and Drug Administration approved its smallpox vaccine for Mpox disease in individuals at high risk for infection. Emergent stock was up 8.6% to $9.68 in trading Friday. Earlier this month, the World Health Organization declared the Mpox outbreak a public-health emergency of international concern.
The FDA approved a supplemental application to expand Emergent BioSolutions' existing smallpox vaccine to include Mpox.