Dynavax DVAX Gets FDA Heplisav Hold Lifted
September 10, 2009 - After an 18 month hold for safety concerns, Dynavax Technologies Corporation (DVAX) told investors this morning that the FDA has lifted the Hold on Heplisav. Shares of DVAX are set to open at $2.50 Up 43%. What is Heplisav? Heplisav is a vaccine aimed at treating Hepititis B.
Dynavax Reports FDA Removes Clinical Hold on HEPLISAVTM Phase 3 Hepatitis B Vaccine
Dynavax Technologies Corporation (NasdaqVAX) today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold for the HEPLISAVTM Investigational New Drug (IND) application in individuals with chronic kidney disease. HEPLISAV is a Phase 3 investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines.
As a result of the FDA's decision, Dynavax expects to initiate a Phase 3 trial in chronic kidney disease patients in the near-term. Dynavax also plans to initiate a Phase 3 lot-to-lot consistency trial in adults over 40 years of age in early 2010.
"The success of our scientific approach to resolving the clinical hold on HEPLISAV allows us to resume development of our enhanced hepatitis B vaccine," commented Dino Dina, M.D., President and Chief Executive Officer of Dynavax. "After achieving strong efficacy data in our prior Phase 3 pivotal trial, we are fully prepared to initiate the final registration trials for HEPLISAV."
Dynavax's global strategy as previously discussed with the FDA and the European Medicines Evaluation Agency (EMEA) is to develop HEPLISAV for populations that are less responsive to current licensed vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and others.
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发表于 5-9-2009 12:47 PM
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