Dynavax Technologies Corp (DVAX) 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 approved.
The collection of data on a broader population will facilitate review of the indication in adults in the age bracket of 18-70.
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.
Our Take
The news regarding the necessity to conduct an additional safety trial is disappointing and a major setback for Dynavax.
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 with GlaxoSmithKline (GSK). 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 AstraZeneca (AZN).
Dynavax carries a Zacks Rank #3 (Hold). Right now, Anika Therapeutics Inc. (ANIK) looks well-placed with a Zacks Rank #1 (Strong Buy).
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