DVAX May 2024 11.000 call

UPDATE 1-US FDA declines to approve expanded use of Dynavax's hepatitis B vaccine

Dynavax Technologies said on Tuesday the U.S. Food and Drug Administration (FDA) has declined to approve the expanded use of its hepatitis B vaccine in patients undergoing hemodialysis, citing insufficient safety and effectiveness data. The FDA, in its so-called "complete response letter", stated that the data was insufficient as a third-party clinical trial site operator had destroyed data source documents for about half of the subjects enrolled in the vaccine's trial, according to the company. Dynavax's vaccine, Heplisav-B, was first approved by the FDA in 2017, having been rejected twice before in 2013 and 2016 over unresolved safety concerns.