- Investors in Dynavax (DVAX +5.6%) have been on a rollercoaster today. An FDA advisory committee will review its marketing application for hepatitis B vaccine HEPLISAV-B on Friday.
- Shares were originally up ~20% premarket after the briefing docs were published, then dropped over 10% over concerns that the FDA review team was still not entirely on board with the safety data. Shares have since rallied almost 30% from the intraday low of $8.15.
- Longs are no doubt encouraged by the comment on page 52 of the FDA briefing doc from the cardiology consultants: "Based upon the low likelihood that there is a real safety signal here, and the low absolute risk that these data suggest, we would label the finding in section 6 only and consider ways to monitor this risk post-marketing through some passive surveillance system."
- Previously: Dynavax down 11% premarket ahead of Ad Com review of Heplisav-B (July 26)
- Now read: 2 Small Biotech Stocks That Could Get A Boost From ASCO Conference
Original article