This company has been marked as potentially delisted and may not be actively trading. Dynavax Technologies (DVAX) FDA Approvals Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsEarningsFDA EventsHeadlinesInsider TradesOwnershipTrendsBuy This Stock Dynavax Technologies' Drug in the FDA Approval ProcessThis 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. Top-line data - October 21,2025Top-Line Data Phase 1/2Drug: Z-1018Announced Date: October 21, 2025Indication: Shingles Vaccine ProfileAnnouncementDynavax 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 SummaryAt 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 AnnouncementTop-line results - August 21,2025Top-Line Results Phase 1/2Drug: Z-1018Announced Date: August 21, 2025Indication: Shingles Vaccine ProfileAnnouncementDynavax 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 SummaryDynavax 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 Has Dynavax Technologies received FDA approval? As of now, Dynavax Technologies (DVAX) has not received any FDA approvals for its therapy in the last two years. What drugs has Dynavax Technologies submitted to the FDA? In the past two years, Dynavax Technologies (DVAX) has reported FDA regulatory activity for Z-1018. What is the most recent FDA event for Dynavax Technologies? 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." What conditions do Dynavax Technologies' current drugs treat? Currently, Dynavax Technologies has one therapy (Z-1018) targeting the following condition: Shingles Vaccine Profile. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Agios Pharmaceuticals FDA EventsAlterity Therapeutics FDA EventsAxsome Therapeutics FDA EventsCompass Pathways FDA EventsErnexa Therapeutics FDA EventsKymera Therapeutics FDA EventsSAB Biotherapeutics FDA EventsTurn Therapeutics FDA EventsTvardi Therapeutics FDA EventsAgenus FDA EventsAtai Beckley FDA EventsFate Therapeutics FDA EventsGenmab A/S FDA EventsImmuron FDA EventsIonis Pharmaceuticals 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 Related Companies Ligand Pharmaceuticals FDA Events Celldex Therapeutics FDA Events BioCryst Pharmaceuticals FDA Events Innoviva FDA Events Zenas BioPharma FDA Events Novavax FDA Events MannKind FDA Events OPKO Health FDA Events Lexicon Pharmaceuticals FDA Events Geron FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:DVAX last updated on 10/21/2025 by MarketBeat.com Staff. 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Top-line data - October 21,2025Top-Line Data Phase 1/2Drug: Z-1018Announced Date: October 21, 2025Indication: Shingles Vaccine ProfileAnnouncementDynavax 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 SummaryAt 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
Top-line results - August 21,2025Top-Line Results Phase 1/2Drug: Z-1018Announced Date: August 21, 2025Indication: Shingles Vaccine ProfileAnnouncementDynavax 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 SummaryDynavax 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
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