- Dynavax (NASDAQ:DVAX) is up 21% premarket on robust volume ahead of Friday's Ad Com review of its marketing application for hepatitis B vaccine HEPLISAV-B.
- Investors appear to be taking positions expecting a positive vote backing approval. In the FDA briefing doc, though, questions/concerns about the safety profile of HEPLISAV-B remain, which was the reason the company received a CRL in February 2013.
- From page 7: "In summary, Heplisav was shown to have a robust immune response in healthy adults 18- 70 years of age in Studies DV2-HBV-10 and-16. Heplisav met pre-specified noninferiority criteria to an active comparator vaccine, Engerix-B, in these two phase 3 clinical trials. Regarding safety, there appear to be imbalances in deaths and SAEs of MI in DV2-HBV-23, and imbalances in AESIs in DV2-HBV-16 and -23 (the studies that prospectively evaluated these events). Numbers and rates of events are low, and the lack of prospectively defined monitoring and evaluation of cardiac events limits the causal interpretation of these observations."
- FDA briefing doc
- Dynavax briefing doc
- Errata to Dynavax briefing doc
- Now read: 2 More Small Biotechs For The Rest Of 2017
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