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.
Dynavax Technologies Corporation (NASDAQ:DVAX) Q1 2024 Earnings Call Transcript May 8, 2024 Dynavax Technologies Corporation misses on earnings expectations. Reported EPS is $-0.06698 EPS, expectations were $-0.05. DVAX isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here). Operator: Welcome to the Dynavax […]
DVAX earnings call for the period ending March 31, 2024.