Dynavax Technologies Corporation
) is working hard to get its hepatitis B vaccine candidate,
Heplisav, approved in the U.S. and EU.
The company recently submitted its responses to the Day 120
List of Questions issued by the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA). The
list was related to Dynavax's Marketing Authorization Application
(MAA) for Heplisav.
Dynavax expects to receive Day 180 List of Outstanding Issues
from the EMA in the first quarter of 2014.
Shares of Dynavax were up 25.3% in the last two trading days
following the announcement.
Meanwhile, in Oct 2013, Dynavax finalized the design of its
next large-scale clinical study on its hepatitis B vaccine
candidate, Heplisav, following discussions with the U.S. Food and
Drug Administration (FDA).
We remind investors that Dynavax suffered a setback in Jun
2013 when the U.S. Food and Drug Administration (FDA) asked for
additional safety data in response to a meeting with the agency
to discuss the complete response letter (CRL) received earlier in
2013 on hepatitis B vaccine candidate, Heplisav.
The phase III study, HBV-23 (n=8,000), is planned to provide a
sufficiently-sized safety database for the FDA to complete its
review of Biologic License Application (BLA). The phase III study
will evaluate the overall safety and immunogenicity of Heplisav
as compared to
) Engerix-B in adults in the age group of 18 to 70 years. The
study is also expected to generate additional immunogenicity data
on Heplisav in patients suffering from diabetes.
Since Dynavax does not have any other approved product in its
portfolio, we expect investor focus to remain on Heplisav updates
in the near term.
Dynavax currently carries a Zacks Rank #3 (Hold). Right now,
) look well placed. Both carry a Zacks Rank #1 (Strong Buy).
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