Stage (next event)
Quarterly Sales (Approved)
February 24, 2021 (Est)
Catalyst Info & Data Links
TITLE: Heplisav-B, a Hepatitis B Vaccine Quarterly Sales (Approved)
See the quarterly sales graph below
WHAT IS THE CATALYST EVENT?
Approved Quarterly Sales
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
February 24, 2021 (Est)
11-05-2020 Third Quarter 2020 Financial Results
04-08-2020 Dynavax Donates 10,000 Doses of HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] Vaccine to Emergency Healthcare Providers and Hospital Staff to Protect Against Hepatitis B Infections Amidst COVID-19 Pandemic
01-08-2018 Dynavax Announces HEPLISAV-B™ is Now Available in the United States for the Prevention of Hepatitis B in AdultsDynavax Announces HEPLISAV-B™ is Now Available in the United States for the Prevention of Hepatitis B in Adults
2018 Hyer R, McGuire DK, Xing B, Jackson S, Janssen R. Safety of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant in adults. Vaccine. 2018;36(19):2604-2611. doi:10.1016/j.vaccine.2018.03.067
2015 Janssen JM, Jackson S, Heyward WL, Janssen RS. Immunogenicity of an investigational hepatitis B vaccine with a toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in subpopulations of healthy adults 18-70 years of age. Vaccine. 2015;33(31):3614-3618. doi:10.1016/j.vaccine.2015.05.070
2015 Janssen JM, Heyward WL, Martin JT, Janssen RS. Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease and type 2 diabetes mellitus. Vaccine. 2015;33(7):833-837. doi:10.1016/j.vaccine.2014.12.060
MECHANISM OF ACTION
Unlike traditional 3-dose vaccines that use an alum adjuvant with no specific cellular response, HEPLISAV-B combines a yeast-derived recombinant hepatitis B surface antigen (HBsAg) with the proprietary adjuvant, 1018, to activate Toll-like receptor 9 (TLR9) expressed on first-responder immune cells for direct immune stimulation.
The proprietary antigen is taken up by the TLR9-expressing antigen-presenting cell to trigger a cascade of robust immunostimulatory responses. This may induce a highly specific, helper T-cell response to generate memory T and B cells.
Updated by MV
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