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Dynavax Shares On The Mend As The Hepsilav Saga Continues

Dynavax Shares On The Mend As The Hepsilav Saga Continues

Shares of Dynavax Technologies Corporation (NASDAQ: DVAX) surged by 20 percent Monday after the clinical-stage bio pharmaceutical company released a regulatory filing.

In its filing, Dynavax said it received from the U.S. Food and Drug Administration a request for information concerning its Biologics License Application (BLA) which seeks approval for its Hepatitis B vaccine called HELISAV-b.

Dynavax's disclosure is notable because the FDA canceled an upcoming ADCOM meeting on September 2. The meeting, which was originally scheduled for November, 16 was canceled. The FDA noted the cancellation gives it more time to "review and resolve several outstanding issues." The agency did add it will continue evaluating the vaccine and schedule an Advisory Committee in the future, as needed.

Dynavax's stock plummeted more than 30 percent after the FDA canceled its meeting. Shares opened for trading on September 2 at $16.01, but the FDA's announcement resulted in the stock trading as low as $10.14 before closing the day at $10.91.

Investors had reason to worry since an ADCOM meeting is typically one of the final steps for the FDA to approve a drug or not.

On Monday, Dynavax said the questions it has received from the FDA's review team is "in line with the company's expectations." The company added it's working with the FDA to answer the questions so the FDA can complete a review prior to the scheduled Prescription Drug User Fee Act (PDUFA)action date of December 15, 2016.

Shares traded recently at $12.98, up 23 percent on the day.

Posted-In: Biologics License Application HELISAV-B HepsilavNews Health Care FDA Movers General Best of Benzinga


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