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.