Dynavax Technologies Corp. (DVAX) said the European Medicines Agency or EMA has accepted the filing of the Marketing Authorization Application or MAA for HEPLISAV, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age and in patients with chronic kidney disease. The MAA acceptance confirms that the submission is sufficiently complete to permit a substantive review by the EMA.
HEPLISAV is an investigational adult hepatitis B vaccine for which a U.S. BLA has been accepted for review by the FDA and a MAA has been accepted for review by the EMA.
"This milestone marks the initiation of the regulatory review for HEPLISAV in Europe," said Dynavax President and Chief Medical Officer, Tyler Martin, M.D. The company looks forward to working through the review process with its designated rapporteur from Sweden and co-rapporteur from Belgium.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.