Vaxart, Inc. operates as a clinical-stage biotechnology company, which engages in the development of oral recombinant vaccines based on its Vector-Adjuvant-Antigen Standardized Technology oral vaccine platform. Its investigational vaccines are administered using a room temperature-stable tablet, rather than by injection. It is developing prophylactic vaccine candidates that target a range of infectious diseases, including SARS-CoV-2, norovirus, seasonal influenza and respiratory syncytial virus (RSV). The company was founded in March 2004 and is headquartered in South San Francisco, CA.
Clinical Trials
23
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2004
Active, not recruiting
1
4.3%
Completed
20
87.0%
Terminated
1
4.3%
Withdrawn
1
4.3%
No approval data available
- Vaxart's 400-participant Sentinel cohort showed its oral COVID-19 vaccine had fewer systemic side effects than an mRNA comparator, with no vaccine-related serious adverse events over 12 months. - The company remains on track to report top-line data from the fully enrolled ~5,000-participant main cohort targeting the KP.2 variant in the first half of 2027. - BARDA released $29 million in dedicated funding for expanded exploratory analyses including mucosal immunity profiling and sub-variant genomic sequencing. - Vaxart continues disciplined pursuit of a norovirus partnership while extending its cash runway into Q2 2027 with $64 million in cash and equivalents.
- Vaxart's two newest independent directors, James Breitmeyer and Kevin Finney, sent a letter to shareholders urging votes for all six board nominees on the WHITE proxy card ahead of the July 16, 2026 Annual Meeting. - The letter emphasizes that the dissident shareholder nominees lack relevant biotechnology, public company leadership, or vaccine regulatory experience, and their election would be "value destructive." - Vaxart is advancing a BARDA-funded Phase 2b COVID-19 oral vaccine trial comparing its pill candidate against an approved mRNA injectable, with near-term safety and immunogenicity data expected from a 400-participant Sentinel Cohort. - The company extended its cash runway into Q2 2027 through a strategic partnership with Dynavax (now part of Sanofi) and secured a $25 million share purchase agreement with Lincoln Park Capital.
- 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.
- Vaxart will present Phase 1 clinical trial results for its second-generation norovirus oral pill vaccine at IDWeek 2025, demonstrating improved immune responses to GI.1 and GII.4 strains. - The company's proprietary oral vaccine platform eliminates refrigeration requirements and needle-stick injury risks while generating both systemic and mucosal immune responses. - Vaxart's development pipeline includes oral pill vaccines for coronavirus, norovirus, influenza, and a therapeutic HPV vaccine for immune-oncology applications. - The bivalent norovirus vaccine candidate represents recent improvements designed to enhance immunogenicity and potentially efficacy compared to previous formulations.
- The Department of Health and Human Services issued a stop work order on August 5, 2025, halting Vaxart's Phase IIb trial for VXA-CoV2-3.3, an oral COVID-19 vaccine that had enrolled approximately 5,000 of its targeted 10,000 participants. - The order coincided with HHS's announcement to wind down mRNA vaccine development activities under BARDA, canceling over 20 projects worth nearly $500 million combined. - This marks the second regulatory freeze for Vaxart's oral vaccine program, following a previous stop work order in February 2025 that was lifted in April, highlighting ongoing regulatory uncertainty for the $460.7 million BARDA-funded project. - Vaxart's investigational pill vaccine is designed to provide broad protection against SARS-CoV-2 variants and reduce viral transmission, representing a novel oral delivery approach compared to existing injectable COVID-19 vaccines.
- Avacta Group plc has appointed David Liebowitz, M.D., Ph.D. as Chief Medical Officer to lead clinical strategy and execution for its targeted cancer therapy pipeline. - Liebowitz brings over 30 years of experience in oncology drug development and has contributed to more than 25 Investigational New Drug applications throughout his career. - The company also appointed Yulii Bogatyrenko as business development advisor to strengthen corporate growth strategy and pipeline advancement. - These appointments come at a pivotal time as Avacta continues to advance its pre|CISION platform for targeted oncology drug delivery.
• The Department of Health and Human Services has issued a Stop Work Order for GeoVax's investigational COVID-19 vaccine GEO-CM04S1, withdrawing funding previously granted under Project NextGen. • GeoVax's vaccine candidate was designed to provide broader and more durable COVID-19 protection, showing promise in both primary vaccination and as a booster, particularly for immunocompromised patients. • This termination follows similar funding cuts to other biotechs including Vaxart and CastleVax, raising questions about shifting priorities in vaccine development under the current HHS leadership.
- Phase 1b trial results published in Science Translational Medicine demonstrate strong and durable antibody responses to Vaxart's oral norovirus vaccine in elderly adults, despite age-related immune challenges. - The vaccine candidate generated significant serum antibody responses across all dose cohorts, with increases in anti-VP1 IgA and IgG levels observed at days 29 and 57 post-vaccination. - The oral vaccine demonstrated excellent safety profile with only mild to moderate side effects, while successfully inducing both mucosal-homing B cells and T cells, suggesting potential for robust protection against infection.
- Vaxart's Phase 2b trial of its oral COVID-19 vaccine candidate received a favorable review from the independent Data Safety Monitoring Board (DSMB). - The DSMB recommended the trial proceed without modifications after assessing 30-day safety data from a sentinel cohort of 400 participants. - Vaxart plans to enroll approximately 10,000 participants upon favorable review from the FDA and approval from BARDA. - The Phase 2b trial compares Vaxart's oral vaccine to an approved mRNA injectable vaccine in previously immunized adults.
- Vaxart's Phase 2b COVID-19 oral vaccine trial is set to expand to 10,000 participants, pending FDA review of safety data and BARDA approval. - A Phase 1 trial for Vaxart's second-generation oral norovirus vaccine constructs is planned for the first half of 2025, with initial data expected by mid-2025. - Preclinical studies are underway for a new avian influenza vaccine candidate, designed to address the latest clade 2.3.4.4b strains. - Vaxart's existing funding, including a Project NextGen award, is expected to sustain operations into 2026, supporting key clinical and regulatory milestones.
