Feb 18 Dynavax Technologies Corp said
it had withdrawn a European marketing application for its
experimental hepatitis B vaccine due to safety concerns raised
by the European Medicines Agency.
The EMA had said current safety data on the vaccine,
Heplisav, was too limited to rule out a risk of "less common
serious adverse events."
Heplisav is the company's most advanced produced under
The drug developer said it withdrew the application because
it would not be able to gather sufficient data to respond to the
regulator in the time required.
An additional 8,000-subject trial intended to provide the
data is expected to begin soon, the company said.
Berkeley, California-based Dynavax suffered a similar
setback in February last year when the U.S. Food and Drug
Administration rejected the vaccine.
Dynavax's shares, which fell about 3 percent in early
trading, were were up 1.7 percent at $1.79 on the Nasdaq.