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Dynavax Reports Top Line Results of Phase 3 HEPLISAV-B(TM) Study; BLA Resubmission Targeted for End of Q1 2016

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DVAX

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Management Comment "We are delighted to report these topline results from HBV-23 and confirm our intention to resubmit the HEPLISAV-B BLA by the end of March. These results support our belief that HEPLISAV-B, if approved, could offer benefits to adults at risk for hepatitis B, particularly given that these significant differences in seroprotection were demonstrated in a controlled setting, where compliance is optimized," said Eddie Gray, Chief Executive Officer. "These topline results are consistent with our expectations. With regard to the principal safety focus, Adverse Events of Special Interest, the results reflect a distribution consistent with randomization. To see such statistically significant differences in immunogenicity so consistently and across all groups and patient subsets, confirms the potential of HEPLISAV-B for people in need of protection," said Robert Janssen, Chief Medical Officer.
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Catalyst Date
Occurred on:
Mar 30, 2016
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Related Keywords Top-line Results, Phase 3, Heplisav-b, Hbv-23, Engerix-b