- Dynavax Technologies Corp said the U.S. Food and Drug Administration
asked for additional safety data on its experimental hepatitis B vaccine
potentially delaying its approval and sending its shares down as much
as 30 percent.
Analysts said the company will
be required to conduct an additional trial on Heplisav - Dynavax's most
advanced clinical candidate.
Cowen and Co analyst Phil Nadeau said the outcome of Dynavax' meeting with the FDA was disappointing.
Labels: drugs in development, Hepislav, vaccines