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News Breaks
April 15, 2014
06:08 EDTDVAXDynavax initiates Phase 3 study of HEPLISAV-B
Dynavax Technologies announced initiation of a new phase 3 clinical trial of HEPLISAV-B, its investigational adult hepatitis B vaccine. This large safety and immunogenicity study, known as HBV-23, was designed to address the Complete Response Letter regarding the HEPLISAV-B Biologics License Application that was issued to Dynavax by the FDA in February, 2013. HBV-23 will provide greater clarity regarding the safety profile of HEPLISAV-B by significantly expanding the overall database of vaccinated subjects. The study will also assess the immunogenicity of HEPLISAV-B in subjects for whom approved hepatitis B vaccines are less effective. Dynavax expects that all study subjects will be enrolled by the end of 2014 and all follow-up will be completed by 4Q15.
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July 22, 2015
08:17 EDTDVAXDynavax 4.55M share Spot Secondary priced at $27.50
Cowen, RBC Capital and William Blair acted as joint book running managers for the offering.
July 21, 2015
16:02 EDTDVAXDynavax files to sell common stock, no amount given
Dynavax anticipates using the net proceeds from the proposed offering to fund activities associated with completing the ongoing Phase 3 HBV-23 study of HEPLISAV-B(TM), seeking regulatory approval of HEPLISAV-B in the United States, and preparing for the anticipated U.S. commercial launch of HEPLISAV-B, should HEPLISAV-B gain approval by the Food and Drug Administration. In addition, net proceeds from the offering will support continuing the clinical development of our investigational cancer immunotherapeutic product candidate, SD-101, and for other general corporate purposes, including working capital. Cowen and Company, RBC Capital Markets and William Blair are acting as joint book-running managers for the offering.

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