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Stock Market & Financial Investment News

News Breaks
February 22, 2013
14:06 EDTDVAXDynavax options active into PDUFA
Dynavax March 4 and 6 calls are active on total call volume of 7K contracts (3K puts). March call option implied volatility is at 217, April is at 168, July is at 119; compared to its 26-week average of 116 according to Track Data. Active option volume suggests traders taking positions for larger price movement into PDUFA Date for Heplisav on February 24.
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September 22, 2014
06:02 EDTDVAXDynavax completes enrollment of HEPLISAV-B Phase 3 study
Dynavax Technologies announced completion of planned enrollment in the ongoing phase 3 clinical trial of HEPLISAV-B, its investigational adult hepatitis B vaccine. More than 8,250 adults, including over 1,100 diabetic subjects, have been enrolled at 40 sites in the U.S. This large safety and immunogenicity study is intended to provide an adequately-sized database of vaccinated subjects to enable the FDA to complete its review of the pending HEPLISAV-B Biologics License Application. The study is also designed to assess the immunogenicity of HEPLISAV-B in adults for whom approved hepatitis B vaccines are less effective, including those with type-2 diabetes mellitus.

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