Back to top

Analyst Blog

This page is temporarily not available.  Please check later as it should be available shortly. If you have any questions, please email customer support at support@zacks.com or call 800-767-3771 ext.  9339.

Dynavax Technologies Corp (DVAX - Snapshot Report) 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 - Analyst Report). 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 - Analyst Report).

Dynavax carries a Zacks Rank #3 (Hold). Right now, Anika Therapeutics Inc. looks well-placed with a Zacks Rank #1 (Strong Buy).

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

Learn more

Start for as little as $4.50 per trade.

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
DIXIE GROUP DXYN 15.84 +7.90%
BOFL HOLDING BOFI 85.30 +4.97%
RAMBUS INC RMBS 12.31 +4.41%
VIPSHOP HOLD VIPS 148.73 +4.35%
NETFLIX INC NFLX 345.74 +4.32%