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Dynavax Technologies' Stock Plunges on Vaccine Safety Concern


A panel of government advisers Thursday determined that Dynavax's experimental product Heplisav for hepatitis B has not been shown to be safe. Near-term FDA approval is unlikely.

MINYANVILLE ORIGINAL Dynavax Technologies' (NASDAQ:DVAX) stock is plummeting Friday after a panel of government advisers said it wasn't convinced that the company's experimental vaccine for hepatitis B was safe.

The advisers to the Food and Drug Administration voted 8-5, saying there wasn't enough study data from the company to show Heplisav was safe. The advisers also voted 13-1 to support the apparent effectiveness of the vaccine in treating adults. The FDA will consider the panel recommendations and will make a decision on a possible approval by February 24. It's not likely that the FDA is going to approve a product if there are safety questions.

Shares of Dynavax fell by 51% to $2.29 in early trading Friday.

Some analysts gave the product a strong chance of being approved, but safety concerns were a known issue. Dynavax said the market for adult vaccines for hepatitis B is a $700 million per year opportunity. Merck (NYSE:MRK) and GlaxoSmithKline (NYSE:GSK) already have products on the market.

(See also: Dynavax Technologies Shares Rise on Hope for New Vaccine.)

Twitter: @brettchase

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