Dynavax Technologies Corporation
) reported a loss of 9 cents per share in the third quarter of
2013, in line with the Zacks Consensus Estimate, but narrowed
from the year-ago loss of 10 cents per share.
Dynavax reported revenues of $2.9 million, up 1.8% from the
year-ago period and surpassing the Zacks Consensus Estimate of $2
Collaboration revenues came in at $1.1 million, up 5.7% from
the year-ago quarter.
Grant revenue from Dynavax contract for adjuvant development
awarded by the National Institutes of Health grew 39.4% to $1.7
million from the year-ago quarter.
Research and development expenses declined 8.4% to $11.8
million in the third quarter of 2013. General and administrative
expenses declined 18.4% to $5.8 million.
We remind investors that Dynavax is developing a hepatitis B
vaccine for adults - Heplisav, which is currently under review in
the U.S. and Europe.
Last month, Dynavax received encouraging news when the design
of its next large-scale clinical study on Heplisav, was finalized
following discussions with the U.S. Food and Drug Administration
We note that Dynavax suffered a setback in Jun 2013 when the
FDA asked for additional safety data on Heplisav. The company had
conducted a meeting with the agency to discuss the complete
response letter (CRL) received earlier this year for the Heplisav
Biologic License Application (BLA).
The FDA had then stated that the database needed additional
subjects as analyzing the safety profile on the current database
would probably lead to an approval for a limited population,
thereby preventing additional patients to benefit from the
treatment, if approved.
Apart from Heplisav, Dynavax is also developing AZD1419, for
the treatment of asthma, in partnership with
) and DV1179 (autoimmune and inflammatory diseases) with
The third quarter results did not surprise us. We expect
investor focus to remain on Heplisav updates.
Dynavax carries a Zacks Rank #4 (Sell). Right now,
) looks well placed with a Zacks Rank #1 (Strong Buy).
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