Dynavax Technologies Corporation (DVAX)
After hours:
- Reuters
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.
- PR Newswire
Dynavax Provides Regulatory Update on sBLA for Four-Dose HEPLISAV-B® Regimen for Adults on Hemodialysis in the U.S.
Dynavax Technologies Corporation (Nasdaq: DVAX) today provided a regulatory update for the Company's supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted] regimen for adults on hemodialysis. The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the sBLA, stating that the application did not provide sufficient data to support the full evaluation of effectiveness
- Simply Wall St.
Analysts Are Updating Their Dynavax Technologies Corporation (NASDAQ:DVAX) Estimates After Its First-Quarter Results
Dynavax Technologies Corporation ( NASDAQ:DVAX ) just released its latest first-quarter report and things are not...
