Dynavax Technologies Corp
) recently suffered a setback when the US Food and Drug
Administration (FDA) asked for additional safety data on its
hepatitis B vaccine candidate, 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 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
The collection of data on a broader population will facilitate
review of the indication in adults in the age bracket of
Dynavax intends to meet with the FDA soon to discuss the
protocol for the additional safety trial, which will then be
incorporated into the existing BLA.
The news regarding the necessity to conduct an additional
safety trial is disappointing and a major setback for
It is all the more disappointing as in its CRL, the FDA had
said that while Heplisav could not be approved for the 18-70
years patient population without further evaluation of safety in
this broad age group, it was willing to continue discussions
regarding a more restricted use of Heplisav.
Currently, we have low visibility on the time and cost
involved in conducting the safety study. Shares were down
43.3% on the news.
We note that Dynavax is developing Heplisav in collaboration
). Heplisav is currently under review in Europe.
Dynavax currently does not have any approved product in its
portfolio. We expect investor focus to remain on Heplisav updates
in the near term.
Apart from lead candidate Heplisav, Dynavax is also developing
AZD1419, for the treatment of asthma, in partnership with
Dynavax carries a Zacks Rank #3 (Hold). Right now,
Anika Therapeutics Inc.
) looks well-placed with a Zacks Rank #1 (Strong Buy).
ANIKA THERAPEUT (ANIK): Free Stock Analysis
ASTRAZENECA PLC (AZN): Free Stock Analysis
DYNAVAX TECH CP (DVAX): Free Stock Analysis
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