Dynavax Technologies Corp. operates as a biopharmaceutical company, which engages in the discovery, development, and commercialization of novel vaccines and immuno-oncology therapeutics. Its product includes HEPLISAV-B, which prevents infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The company was founded by Lawrence M. Lichtenstein, Dennis A. Carson, and Eyal Raz on August 29, 1996 and is headquartered in Emeryville, CA.
Clinical Trials
32
7 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
7
21.9%
Completed
18
56.3%
Recruiting
2
6.3%
Terminated
5
15.6%
No approval data available
- The global vaccine adjuvants market was valued at USD 4.00 billion in 2025 and is projected to reach USD 6.19 billion by 2035, growing at a CAGR of 4.47%. - The U.S. market alone is expected to expand from USD 0.62 billion in 2025 to USD 1.61 billion by 2035, reflecting a robust CAGR of 9.05%. - Oncology vaccines represent the fastest-growing application segment, fueled by investments in cancer immunotherapy, personalized vaccines, and neoantigen-based therapies. - Combination adjuvants and intradermal administration are poised for the most rapid growth, while GSK and Novavax continue advancing next-generation adjuvant platforms.
- Dynavax Technologies has entered an exclusive worldwide licensing agreement with Vaxart for its investigational oral COVID-19 vaccine, paying $25 million upfront plus a $5 million equity investment. - The oral vaccine candidate uses Vaxart's proprietary VAAST platform to deliver room-temperature stable pills that may induce mucosal immunity and eliminate needle-stick risks. - Vaxart will complete its ongoing Phase 2b trial comparing the oral vaccine to an FDA-approved mRNA vaccine in 5,400 participants, with topline results expected in late 2026. - The deal structure allows Dynavax to evaluate Phase 2b data before committing to late-stage development, with potential total payments reaching up to $695 million including milestones and royalties.
- Valneva's VLA1601 second-generation Zika vaccine candidate demonstrated improved immunogenicity with peak seroconversion rates exceeding 93% compared to 86% for the first-generation candidate. - The Phase 1 trial enrolled approximately 150 participants aged 18-49 years, with double-adjuvanted formulations showing statistically significantly higher neutralizing antibody titers than single-adjuvant treatments. - Despite positive safety and efficacy results, Valneva will only pursue further development if major private and public funding opportunities materialize due to uncertain regulatory pathways and market opportunities. - The vaccine addresses a significant global health threat, with 89 countries and territories reporting mosquito-borne Zika virus transmission and WHO consensus linking infection to congenital microcephaly and Guillain-Barré syndrome.
- Dynavax Technologies reported positive topline results from a Phase 1/2 trial of Z-1018, demonstrating immune responses comparable to the leading shingles vaccine Shingrix. - The experimental vaccine candidate showed fewer moderate or severe side effects compared to existing treatments, potentially offering a safety advantage. - The company plans to initiate studies in older adults later in 2025, marking a critical next phase in the vaccine's development. - Following the announcement, analysts maintain optimistic price targets with JMP Securities setting a $32 target and rating the stock as "Market Outperform."
- Dynavax's investigational shingles vaccine Z-1018 demonstrated comparable immune responses to GSK's Shingrix, achieving a 100% humoral vaccine response rate versus 96.9% for Shingrix in adults aged 50-69 years. - The vaccine candidate showed significantly better tolerability with only 12.5% of participants experiencing grade 2-3 local reactions compared to 52.6% for Shingrix, and 27.5% versus 63.2% for systemic reactions. - Based on these positive Phase I/II Part 1 results, Dynavax plans to advance Z-1018 to Part 2 trials in adults 70 years and older, expected to begin in the second half of 2025.
• Sonoma Biotherapeutics has appointed Rajesh Krishnan, Ph.D., as Chief Technical Officer to advance their engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases. • Dr. Krishnan brings over 25 years of industry experience in process development and manufacturing, most recently serving as CTO and CSO at Oncternal Therapeutics with previous leadership roles at Dynavax, Gilead, Merck, Amgen, and Pfizer. • The strategic appointment comes at a crucial time for the clinical-stage biotech company as they continue developing novel treatments aimed at restoring immune system balance through proprietary Treg cell therapy platforms.
- HEPLISAV-B achieved record net product revenue of $268.4 million in 2024, representing a 26% year-over-year growth, with market share reaching 44% in the U.S. hepatitis B vaccine market. - Dynavax expects to report top-line results from its Phase 1/2 shingles vaccine trial in Q3 2025 and plans to initiate a Phase 2 plague vaccine trial in collaboration with the U.S. Department of Defense. - The company projects HEPLISAV-B net product revenue to reach $305-325 million in 2025 and anticipates completing its $200 million share repurchase program by year-end.
- Goldman Sachs has downgraded Dynavax Technologies to Sell from Neutral, reducing price target to $12 amid growing competition in the shingles vaccine market and uncertainties around Z-1018 program. - Dynavax's HEPLISAV-B showed strong performance with preliminary 2024 net product revenue of $268 million, up 26% year-over-year, despite regulatory challenges with its four-dose regimen. - GSK's Shingrix advancement with pre-filled syringes, under FDA and EMA review, poses additional competitive challenges to Dynavax's market position.
- A phase 3 trial showed HepB-CpG vaccine achieved superior seroprotection in HIV patients who did not respond to prior HepB-alum vaccination. - 93.1% of participants achieved seroprotection with two doses of HepB-CpG, while 99.4% achieved it with three doses. - In comparison, only 80.6% of participants achieved seroprotection with three doses of the conventional HepB-alum vaccine. - The findings support using HepB-CpG vaccine for both vaccine-naive individuals and those with prior non-response to traditional hepatitis B vaccines.
