Dynavax Technologies Corporation (NASDAQ:DVAX) Addresses FDA Indications – GSK, AZN


Dallas, Texas 09/17/2013 (Financialstrend) – A clinical-stage biopharmaceutical company, Dynavax Technologies Corporation (NASDAQ:DVAX) is engaged in discovery and development of novel pharmaceutical molecules based on the use of immuno-regulatory and immuno-stimulatory sequences, largely for the prevention and treatment of infectious and inflammatory diseases. Its drug portfolio includes HEPLISAV (Phase lll), DV1179 (Phase l), and AZD1419 (preclinical). The company is committed to develop novel TLR (Toll Like Receptor) based drugs addressing serious medicinal needs in partnership with pharmaceutical giants GlaxoSmithKline plc (ADR) (NYSE:GSK) and AstraZeneca plc (ADR) (NYSE:AZN).

On Monday, September 16 the stock closed at $1.21, around 1.68% up from its previous close. At the current price the stock is trading along its 52-week low of $0.98 and is trading almost 76% below its 52-week high of $5.10. The stock has plunged over 70% in the trailing twelve month period, losing around $3.34 per share.

This plunge is because of delay in the commercialization of HEPLISAV, a phase-3 investigational adult hepatitis B vaccine and the lead product candidate of Dynavax Technologies Corporation (NASDAQ:DVAX), following one of the biggest FDA rejections for the year 2013. The rejection was, at large, because of safety concerns of the promising hepatitis B vaccine which showed evidence of longer lasting protection compared to currently licensed vaccines Engerix-B, Twinrix, and Recombivax-HB. However, the company is working on to fulfill the gaps by collecting required data towards addressing the safety concerns raised by the USFDA.

The company holds global commercial rights for the promising and much speculative HEPLISAV vaccine. The global market for adult hepatitis B vaccines is estimated to be more than $690 million annually. Moreover, the European Medicines Agency accepted the Marketing Authority Authorization filing for HEPLISAV in August 2012.

Dynavax Technologies Corporation (NASDAQ:DVAX) was also alleged for lacking satisfactory evidences with regards to positive statements and company’s outlook about the launch of HEPLISAV in 2013.