Dynavax falls as FDA declines expanded use of hepatitis B vaccine in dialysis patients

Dynavax Technologies

14/05/2024 13:57

** Shares of vaccine maker Dynavax Technologies  DVAX.O 
fall 6.6% to $10.30 premarket.
    ** Co says FDA has declined to approve the expanded use of
its hepatitis B vaccine in adults on hemodialysis
    ** The health regulator said the application did not provide
sufficient data to support the full evaluation of effectiveness
or safety of a four-dose regimen of the vaccine, known as
Heplisav-B
    ** The decision has no impact on the approved indication for
the vaccine in the U.S. for known subtypes of hepatitis B virus
in adults - DVAX
    ** Adds it also doesn't affect the approval decision
received from the European Commission in October 2023 for the
four-dose regimen for the adult hemodialysis population
    ** Up to last close, stock down 21% YTD

 (Reporting by Sriparna Roy in Bengaluru)
 ((Sriparna.Roy@thomsonreuters.com;))