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By Chris Wack
Emergent BioSolutions shares were up 16% to $8.22 in premarket trading after the company said late Thursday that the U.S. Food and Drug Administration has approved Cyfendus for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years old.
The stock hit its 52-week low of $6.77 on July 6, and is down 78% as of Thursday’s close.
The company said the efficacy of the Cyfendus vaccine for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.
Emergent BioSolutions said Cyfendus has been demonstrated that by using an additional adjuvant, two doses administered over 14 days elicit protective levels of immune response, which can be especially important in response to a large-scale public health emergency involving anthrax.
In December 2018, Cyfendus was the subject of a pre-emergency use authorization package submitted to the FDA. In 2019, the U.S. government began procuring this product for national preparedness efforts.
Write to Chris Wack at [email protected]
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