Dynavax Technologies Corporation (NASDAQ:DVAX), a clinical-stage biotech in the field of autoimmunology, is surging 20%-plus for the second time in less than a month, this time as DVAX revealed requests for information regarding Heplisav-B from the Food and Drug Administration.
The review is scheduled to conclude on Dec. 15, and Dynavax’s cooperation with the FDA review team hopes to answer any remaining questions.
So why is this good news, exactly? Considering Dynavax stock is up 25% as of this writing, it’s actually great news. That’s because the FDA’s questions line up with what DVAX was expecting, which bodes well for its review going off without a hitch.
The request for information is in regards to a pending biologic license application for Heplisav-B, and is needed for the hepatitis B vaccine to make its prescription drug user fee action date of Dec. 15.
Today’s move comes on a day that the rest of the biotech sector is somewhat in shambles. The iShares Nasdaq Biotechnology Index (ETF) (NASDAQ:IBB) is off a percent, driven down by Mylan NV (NASDAQ:MYL), Pfizer Inc. (NYSE:PFE) and others.
The last time DVAX stock popped, it was on wind of a Cepheid (NASDAQ:CPHD) buyout at the hands of Danaher Corporation (NYSE:DHR). The biotech market’s ears perked up on the announcement, prompting many to believe Dynavax could be the next M&A target.
If you recall, however, just before Dynavax shares surged, they plummeted by more than 30%. That’s because the FDA had cancelled its meeting with Dynavax concerning Heplisav.
Monday’s action is largely gaining back what it lost, as the market begins to lose its trepidation over the pending approval of Dynavax’s Heplisav-B treatment.
As of this writing, John Kilhefner did not hold a position in any of the aforementioned securities.