Dynavax Technologies Corp. (DVAX) announced Thursday that the U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee voted 13 to one that Heplisav data adequately demonstrated immunogenicity.
In additon, the Committee voted eight to five with one abstention that there was insufficient data to adequately support the safety of Heplisav.
The scheduled Prescription Drug User Fee Act (PDUFA) date for Heplisav is February 24, 2013.
Heplisav is an investigational adult hepatitis B vaccine for which U.S. and European licensure applications have been accepted for review by the FDA and the EMA.
The company said it has worldwide commercial rights to Heplisav. Heplisav combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
DVAX closed Thursday's regular trading at $4.63. In the after-hours, the stock is down $2.92 or 63.07%.
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