Dynavax dips as FDA delays sBLA for four-dose Heplisav-B

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the supplemental Biologics License Application (sBLA), stating that the application did not provide sufficient data to support the full evaluation of effectiveness or safety of a four-dose regimen of Heplisav-B vaccine, said US immunotherapy specialist Dynavax Technologies (Nasdaq: DVAX).

The sBLA is looking to include a four-dose Heplisav-B [hepatitis B vaccine (Recombinant), adjuvanted] regimen for adults on hemodialysis.

Dynavax, whose shares dipped 3.2% to $10.65 on the news, assured that the CRL has no impact on the approved indication for Heplisav-B in the USA, the European Union, and Great Britain, which is for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The CRL also does not affect the approval decision received from the European Commission in October 2023 for the four-dose Heplisav-B regimen for the adult hemodialysis population.