Dynavax Technologies Corporation
) reported a loss of 9 cents per share in the second quarter of
2014, flat with the year-ago quarter but wider than the Zacks
Consensus Estimate of a loss of 6 cents.
Dynavax reported revenues of $3.1 million, down 10.1% from the
year-ago period but way ahead of the Zacks Consensus Estimate of
Quarter in Detail
Collaboration revenues came in at $2 million, up 49.8% from the
Grant revenue decreased 27.8% to $1 million from the year-ago
Research and development expenses increased 84.6% to $23.6
million in the second quarter of 2014 due to the initiation of the
pivotal phase III trial, HBV-23 and significant subject enrollment
for the trial. General and administrative expenses declined 46.5%
to $4.1 million.
Dynavax is developing a hepatitis B vaccine, Heplisav, for
adults. However, Heplisav's road to approval has been bumpy.
Dynavax has received setbacks both in the U.S. and Europe in
getting Heplisav approved.
In Apr 2014, Dynavax commenced a new phase III study (HBV-23) on
Heplisav. HBV-23 is a large safety and immunogenicity study, which
is designed to address the complete response letter (CRL) issued by
the FDA in Feb 2013. 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.
Dynavax expects all subjects to be enrolled by the end of 2014
and all follow-up visits to be completed by the fourth quarter of
We note that Dynavax is also developing AZD1419 for the
treatment of asthma, in partnership with AstraZeneca (
). 4 weekly doses of AZD1419 or placebo were delivered by
inhalation to 45 healthy volunteers in a phase I study. The study
showed that ascending doses of up to 15.4 mg/week for 4 weeks were
well tolerated. Secondary endpoints assessing pharmacodynamics were
Dynavax carries a Zacks Rank #3 (Hold). Right now, Actelion (
) looks well placed with a Zacks Rank #1 (Strong Buy).
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