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Article: Good News for Dynavax - Analyst Blog
- Article from:
- Zacks Investment Research - Analyst Blog
- Article date:
- September 11, 2009
- Author:
CopyrightCopyright 2009 Zacks Investment Research. (Hide copyright information)
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Good News for Dynavax - Analyst Blog
Yesterday, Dynavax Technologies Corp. (
DVAX
) announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on its late-stage hepatitis B vaccine (HBV) Heplisav which is being developed for patients suffering from chronic kidney disease.
As a reminder, Heplisav was on clinical hold in the U.S since Mar 17, 2008 following the report of the severe adverse event (SAE) of Wegener's granulomatosis. The SAE was reported in the phase III study in healthy adults conducted outside the U.S. Wegener's granulomatosis is an uncommon disease which results in the inflammation of blood vessels .The vaccine is being studied for both ...