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.
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About Dynavax
Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics in the areas of infectious diseases and oncology. Dynavax’s lead product candidates are HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine, and SD-101, an investigational cancer immunotherapeutic currently in several Phase 1/2 studies. For more information, visit www.dynavax.com
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