Dynavax Submits Response to EMA - Analyst Blog


Shutterstock photo

Dynavax Technologies Corporation ( DVAX ) is working hard to get its hepatitis B vaccine candidate, Heplisav, approved in the U.S. and EU.

The company recently submitted its responses to the Day 120 List of Questions issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The list was related to Dynavax's Marketing Authorization Application (MAA) for Heplisav.

Dynavax expects to receive Day 180 List of Outstanding Issues from the EMA in the first quarter of 2014.

Shares of Dynavax were up 25.3% in the last two trading days following the announcement.

Meanwhile, in Oct 2013, Dynavax finalized the design of its next large-scale clinical study on its hepatitis B vaccine candidate, Heplisav, following discussions with the U.S. Food and Drug Administration (FDA). 

We remind investors that Dynavax suffered a setback in Jun 2013 when the U.S. Food and Drug Administration (FDA) asked for additional safety data in response to a meeting with the agency to discuss the complete response letter (CRL) received earlier in 2013 on hepatitis B vaccine candidate, Heplisav.

The phase III study, HBV-23 (n=8,000), is planned to provide a sufficiently-sized safety database for the FDA to complete its review of Biologic License Application (BLA). The phase III study will evaluate the overall safety and immunogenicity of Heplisav as compared to GlaxoSmithKline's ( GSK ) Engerix-B in adults in the age group of 18 to 70 years. The study is also expected to generate additional immunogenicity data on Heplisav in patients suffering from diabetes.

Since Dynavax does not have any other approved product in its portfolio, we expect investor focus to remain on Heplisav updates in the near term.

Dynavax currently carries a Zacks Rank #3 (Hold). Right now, Gilead Sciences ( GILD ) and Vanda Pharmaceuticals ( VNDA ) look well placed. Both carry a Zacks Rank #1 (Strong Buy).

DYNAVAX TECH CP (DVAX): Free Stock Analysis Report

GILEAD SCIENCES (GILD): Free Stock Analysis Report

GLAXOSMITHKLINE (GSK): Free Stock Analysis Report

VANDA PHARMACT (VNDA): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

This article appears in: Investing , Business , Stocks
More Headlines for: CHMP , CRL , DVAX , GILD , MAA

More from Zacks.com




Equity Research
Follow on:

Find a Credit Card

Select a credit card product by:
Select an offer:
Data Provided by BankRate.com