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Featured Company News – Dynavax Announces FDA Advisory Committee Vote in Favor of HEPLISAV-B(TM)

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LONDON, UK / ACCESSWIRE / August 1, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Dynavax Technologies Corp. (NASDAQ: DVAX) (“Dynavax”), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=DVAX. The Company announced on July 28, 2017, that the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 12 to one, with three abstention, in favor of HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)], providing immunization against hepatitis B infection in adults 18 years of age and older. For immediate access to our complimentary reports, including today’s coverage, register for free now at:

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The Committee provided commentary on the design of Dynavax’s proposed post-marketing pharmacovigilance plan for HEPLISAV-B. VRBPAC panel was not bound by FDA to vote on the immunogenicity of HEPLISAV-B. However, a prior panel voted 13 to one that Phase-3 clinical trial data supports the vaccine’s effectiveness.

HEPLISA-B Provides Increased Rates of Seroprotection

Eddie Gray, Chief Executive Officer of Dynavax, stated that the Company is encouraged by the committee’s positive vote in favor of HEPLISAV-B, which is believed to become an important new tool in the fight against hepatitis B infection if approved by the FDA. Clinical studies of HEPLISAV-B have shown that the vaccine provides increased rates of seroprotection. In addition, the two-dose regimen offers the potential to increase patient compliance, which physicians and advocates agree is essential to preventing more cases of hepatitis B and achieving the public health goal of eradication. Eddie further stated that Dynavax is looking forward to completing the ongoing discussions with the FDA regarding an appropriate post-marketing commitment as it finalizes its review.

There is no cure for the hepatitis B, and the incidences of the disease in the US are on a rise. Therefore, its prevention through effective vaccination is essential for reducing its spread. Currently, marketed hepatitis B vaccines are administered in three doses over a six-month schedule. In contrast, the HEPLISAV-B regimen is two doses over one month. Vaccine Safety Datalink study results indicate that only 54% of adults completed the currently available three-dose hepatitis B vaccine series in one year. Those who do not complete the series may not be adequately protected against hepatitis B.

Commercial Launch of HEPLISAV-B in US in Early 2018

HEPLISAV-B has a Prescription Drug User Fee Act (PDUFA) date of August 10, 2017. If the vaccine is approved by FDA, Dynavax will seek a recommendation from the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) during its October 2017 meeting.

Dynavax plans to launch the vaccine commercially in the US in early 2018 on its own or through a commercial partner.

About Hepatitis B

Hepatitis B is a viral disease of the liver that can become chronic and can lead to cirrhosis of the liver, hepatocellular carcinoma, and death. The CDC estimates that approximately 850,000 persons are living with hepatitis B virus in the US.

About HEPLISA-B

HEPLISA-B is an investigational vaccine intended for use in the immunization against infection caused by all known subtypes of hepatitis B virus. HEPLISAV-B vaccine combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. In Phase- trials, HEPLISAV-B has shown higher and earlier protection with fewer doses than a currently licensed hepatitis B vaccine.

About Dynavax Technologies Corp.

Dynavax Technologies is a clinical-stage biopharmaceutical company with multiple product candidates in development for the prevention of infectious disease, the treatment of autoimmune and inflammatory diseases, and the treatment of cancer. The Company is headquartered in Berkeley, California.

Last Close Stock Review

On Monday, July 31, 2017, the stock closed the trading session at $15.85, skyrocketing 71.35% from its previous closing price of $9.25. A total volume of 23.08 million shares have exchanged hands, which was higher than the 3-month average volume of 1.80 million shares. Dynavax Technologies’ stock price skyrocketed 185.59% in the last three months, 311.69% in the past six months, and 2.72% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have soared 301.27%. At Monday’s closing price, the stock’s net capitalization stands at $867.79 million.

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