FDA Committee Vote Boosts Dynavax Technologies Corporation (NASDAQ:DVAX)

Dynavax Technologies Corporation (NASDAQ:DVAX)

Dynavax Technologies Corporation (NASDAQ:DVAX) shares are up over 70% on positive news from the U.S. Food and Drug Administration (FDA) and ratings upgrades from RBC Capital Markets and JP Morgan. The listed average daily volume for DVAX shares is 1.8 million but by 11:40 AM EST, over14.6 million shares had traded.

Dynavax Technologies Corporation (NASDAQ:DVAX)
One month daily candlebar graph for $DVAX

The catalyst for the share increase was news, dated last Friday, that the FDA’s Related Biological Products Advisory Committee (VRBPAC) voted 12 to 1 that for Dynavax’s HEPLISAV-B vaccine’s safety data support licensure for immunization against hepatitis B infection in adults. Established hepatitis B vaccines are administered in three doses over a six-month schedule. The HEPLISAV-B schedule is two doses over one month. Results of a published Vaccine Safety Datalink study showed that only 54 percent of adults completed the three-dose hepatitis B vaccine series in one year. Hepatitis B is a viral liver disease that can lead to cirrhosis of the liver, hepatocellular carcinoma, and death. In the U.S., the number of reported cases of acute hepatitis B increased more than 20 percent in 2015.

Eddie Gray, CEO of Dynavax, stated “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. We look forward to completing our ongoing discussions with the FDA regarding an appropriate post-marketing commitment as it finalizes its review.”

Over 11% of Dynavax Technologies Corporation (NASDAQ:DVAX) outstanding shares are held short. In 2012 DVAX shares had an EPS loss, adjusted for dilution, of (-$4.10). In the years that followed losses continued but were steadily narrower: (-$3.83), (-$3.45), (-$3.25), and in 2016 the loss was (-$2.92). However, the number of outstanding shares follows a steady upward trend. In 2012 there were 17.05 million outstanding shares. By 2016 that number had steadily grown and stood at 38.51 million.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.