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Dynavax Stock Climbs On HEPLISAV-B's Approval By FDA For Hepatitis B In Adults

Shares of Dynavax Technologies Corp. (DVAX) climbed around 15 percent in the extended trading on Thursday after the drug maker announced that the U.S. Food and Drug Administration has approved HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for prevention of Hepatitis B in adults.

HEPLISAV-B is the first FDA-approved product for Dynavax. The company expects to commercially launch HEPLISAV-B in the United States in the first quarter of 2018. In preparation for launch, Dynavax has been building commercial infrastructure and optimizing manufacturing processes to meet anticipated demand.

HEPLISAV-B is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults.

The approval is for infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Hepatitis B is an extremely infectious and potentially deadly virus affecting a wide range of adults. There is no cure for hepatitis B, and can be prevented through effective vaccination.

Current hepatitis B vaccines require three shots over a six-month period, however, almost half of adults fail to complete the series within one year.

The approval of HEPLISAV-B was based on data from three Phase 3 non-inferiority trials of nearly 10,000 adult participants who received HEPLISAV-B. Results from the largest Phase 3 trial, which included 6,665 participants, showed that HEPLISAV-B demonstrated a statistically significantly higher rate of protection of 95% compared with 81% for Engerix-B.

Dynavax stock closed Thursday's regular trading at $20.05, down 3.84%. In the after hours trading, shares gained 15.24 percent to $23.10.

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