FDA Response Triggers Dynavax Technologies (DVAX) Sell-off
Dynavax Technologies (NASDAQ: DVAX) is down more than 60% mid-morning after the company said it received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for its HEPLISAV-B™ vaccine against hepatitis B infection. The CRL signals the FDA’s completed a review of an application and stands as a request for additional information for review and approval. Dynavax said it expects a Class 2 designation for a resubmission of the BLA, which would result in a target review period of six months. To view the full press release, visit: http://nnw.fm/9mS6x About Dynavax Dynavax, a clinical-stage biopharmaceutical…