NEW YORK (AP) — Shares of Dynavax Technologies Corp. jumped Thursday after
the company said regulators agreed the company demonstrated the consistency of
its experimental hepatitis B vaccine Heplisav in a recent clinical trial.
Dynavax said the Food and Drug Administration’s Center for Biologics
Evaluation and Research agreed the study proved the company can make consistent
batches of Heplisav.
On July 20, the company said Heplisav did not meet one of its “consistency”
goals in the study because one production lot had higher concentrations of
antibodies than the others after eight weeks. Dynavax stock plunged 19 percent
At the time, the company said Heplisav did meet the consistency criteria at
other points in the study. It said Thursday that the FDA
accepted that reasoning. Dynavax said it still plans to file for FDA approval of Heplisav later this year for use in patients
who do not respond to other therapies.
Shares of the Berkeley, Calif., company rose 57 cents, or 23.5 percent, to $3
in afternoon trading.