This section highlights FDA-related milestones and regulatory updates for drugs developed by Dynavax Technologies (DVAX).
Over the past two years, Dynavax Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
HEPLISAV and Z-1018. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
HEPLISAV B (Recombinant, Adjuvanted) FDA Regulatory Events
HEPLISAV B (Recombinant, Adjuvanted) is a drug developed by Dynavax Technologies for the following indication: hepatitis B virus infection (HBV).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HEPLISAV B (Recombinant, Adjuvanted)
- Announced Date:
- May 14, 2024
- Indication:
- hepatitis B virus infection (HBV)
Announcement
Dynavax Technologies 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.
AI Summary
Dynavax Technologies recently provided an update on its supplemental Biologics License Application (sBLA) aimed at including a four-dose regimen of the HEPLISAV-B® hepatitis B vaccine for adults on hemodialysis. This new dosing schedule is designed to strengthen the immune response in patients on kidney dialysis, a group that is often at higher risk due to a generally weaker immune system. By proposing an extra dose, Dynavax hopes to offer better protection and improved health outcomes for these vulnerable individuals.
The company’s update highlights its commitment to tailoring vaccination strategies to meet the needs of high-risk groups. If approved, this four-dose regimen could bring significant benefits to adults on hemodialysis by reducing the risk of hepatitis B infection and enhancing overall vaccine effectiveness. Further regulatory review will determine the final steps toward implementation.
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Z-1018 FDA Regulatory Events
Z-1018 is a drug developed by Dynavax Technologies for the following indication: Shingles Vaccine Profile.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Z-1018
- Announced Date:
- August 21, 2025
- Indication:
- Shingles Vaccine Profile
Announcement
Dynavax Technologies announced positive topline results from Part 1 of its randomized, observer-blinded, and active-controlled Phase 1/2 clinical trial of Z-1018, the Company's novel shingles vaccine candidate, head-to-head versus Shingrix in participants aged 50 to 69 years.
AI Summary
Dynavax Technologies announced positive topline results from Part 1 of its randomized, observer-blinded, active-controlled Phase 1/2 trial of Z-1018, its novel shingles vaccine candidate, against Shingrix in adults aged 50 to 69. The study evaluated three antigen doses, two adjuvant formulations, and two dosing intervals.
One month after the second dose, Z-1018 induced antibody and CD4⁺ T cell responses comparable to Shingrix, with a 100.0% humoral vaccine response rate versus 96.9% for Shingrix, and an 89.7% cellular response rate versus 93.5%. Composite response rates were 89.7% for Z-1018 and 90.3% for Shingrix. Z-1018 was well tolerated, with only 12.5% of participants reporting grade 2 or 3 local reactions and 27.5% reporting systemic reactions, compared to 52.6% and 63.2% for Shingrix, respectively.
Based on these results, Dynavax selected the 100 µg glycoprotein E dose adjuvanted with CpG 1018 and alum and an 8-week schedule to advance into Part 2 of the trial in adults 70 and older, expected to begin in the second half of 2025.
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