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Data on Dynavax' Heplisav - Analyst Blog
9/25/2013 12:00:00 PM
Dynavax Technologies Corporation ( DVAX ) announced that immunogenicity and safety data from two phase III trials (HBV-16 and HBV-17) on its hepatitis B vaccine candidate, Heplisav, were published in the journal VACCINE .
One of the trials assessed the immunogenicity and safety of Heplisav compared to a licensed hepatitis B vaccine in healthy adults in the age group of 40-70.
The trial was conducted in the U.S. and Canada among 2,400 subjects. The results from the trial showed that Heplisav induced significantly higher seroprotection rates in all groups (including hyporesponsive populations) versus the licensed hepatitis B vaccine in a shorter two-dose schedule over one month.
Dynavax suffered a setback in Jun 2013 when the U.S. Food and Drug Administration (FDA) asked for additional safety data in response to a meeting with the agency to discuss the complete response letter (CRL) received earlier in 2013 on Heplisav. We expect investor focus to remain on Heplisav updates.
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