Dynavax Technologies' Drug in the FDA Approval Process
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
Z-1018. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- October 21, 2025
- Indication:
- Shingles Vaccine Profile
Announcement
Dynavax Technologies today presented positive topline data from Part 1 of its randomized, observer-blinded, active-controlled Phase 1/2 clinical trial of Z-1018, the Company's novel shingles vaccine candidate, in a late-breaker session at IDWeek 2025.
AI Summary
At IDWeek 2025, Dynavax presented topline results from Part 1 of its Phase 1/2 trial of Z-1018, a new shingles vaccine. In this study, adults aged 50–69 received different doses and formulations of Z-1018 or Shingrix. Four weeks after two doses, Z-1018 produced antibody and CD4+ T-cell responses comparable to Shingrix. Z-1018 also drove robust polyfunctional CD4+ T-cell responses, showing activation markers on multiple cell functions. Across dosing levels and intervals, Z-1018 was well tolerated, with mostly mild local and systemic reactions.
The company selected a 100 mcg dose of antigen with CpG 1018 plus alum, given at 0 and 8 weeks, to move forward. Dynavax has now started Part 2, a head-to-head study versus Shingrix in about 324 adults aged 70 and older in Australia and New Zealand. Topline results from Part 2 are expected in late 2026 to confirm Z-1018’s immunogenicity, safety, and tolerability.
Read Announcement- 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.
Read Announcement
Dynavax Technologies FDA Events - Frequently Asked Questions
As of now, Dynavax Technologies (DVAX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Dynavax Technologies (DVAX) has reported FDA regulatory activity for Z-1018.
The most recent FDA-related event for Dynavax Technologies occurred on October 21, 2025, involving Z-1018. The update was categorized as "Top-line data," with the company reporting: "Dynavax Technologies today presented positive topline data from Part 1 of its randomized, observer-blinded, active-controlled Phase 1/2 clinical trial of Z-1018, the Company's novel shingles vaccine candidate, in a late-breaker session at IDWeek 2025."
Currently, Dynavax Technologies has one therapy (Z-1018) targeting the following condition: Shingles Vaccine Profile.
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Companies With Recent FDA Events
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:DVAX last updated on 10/21/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
