Dynavax Technologies Corporation (NASDAQ:DVAX) – Booster Dose of HEPLISAV can Only Help Boost the Stock


Dallas, Texas 09/12/2013 (Financialstrend) – Once known as Double Helix Corporation, Dynavax Technologies Corporation (NASDAQ:DVAX) is California based biopharmaceutical company broadly focused at discovery and development of products for infectious and inflammatory diseases prevention and treatment. Mainly its product research is focused at development of pharmaceutical candidates based on the use of immune-regulatory and immune-stimulatory sequences.

The stock has witnessed the longing down-trend and it closed at $1.20 on Wednesday, September 11. At current price the stock is trading more than 75% below its 52-week high of $5.10. This fall in its share prices is largely attributed to delay in commercialization of HEPLISAV following challenges from the FDA.

Phase-3 investigational adult hepatitis B vaccine, HEPLISAV is the lead product candidate for DVAX and is one of the biggest FDA rejections for the year-so-far. However during the phase-3 trials the vaccine demonstrated earlier and longer lasting protection with lesser dosage compared to currently licensed vaccines like Merck’s Recombivax-HB and GlaxoSmithKline’s Engerix-B and Twinrix.

Though the FDA staff report pointed efficacy and comparable safety profile of HEPLISAV with market leader Engerix-B vaccine, the advisory panel voted against the recommendation questioning the safety concerns followed by rejection of the promising hepatitis B vaccine. Currently the company is working to collect required patient data addressing the safety concerns raised by FDA.

Given the delay in launch of HEPLISAV, The Law Offices of Todd M. Garber alleged the company for issuing misleading statements between April 26, 2012 and June 10, 2013 referred to as the ‘Class Period’. The allegations were mainly concerning company’s inadequate disclosure regarding lack of representative trial demographics, one-year safety follow-up, inadequate safety database, information concerning use with other vaccines, sufficient information regarding manufacturing processes and controls in Biologics License Application. They alleged, with regards to HEPLISAV clinical trial, that the company lacked sufficient evidences for their positive statements pertaining to the company’s outlook including announcements about the launch of HEPLISAV in 2013.