Vaxart Inc

Vaxart reported favorable 12-month safety data from the 400-participant sentinel cohort of its Phase II-B COVID-19 vaccine trial, with no vaccine-related serious complications. The larger, roughly 5,000-participant main cohort is fully enrolled, and top-line data are expected in the first half of 2027, pending BARDA approval. BARDA provided $29 million to fund expanded safety, immunogenicity, and efficacy analyses, including mucosal antibody testing, cellular biomarkers, and genomic sequencing across the main study cohort. Vaxart ended the second quarter of 2026 with $64 million in cash and short-term investments, enough to fund operations into the second quarter of 2027 under its current plan. The company is still seeking a norovirus vaccine partner and has revised board leadership and committee structures following a shareholder cooperation agreement.

Vaxart announced topline 12-month safety results from the 400-participant sentinel safety cohort of its Phase 2b trial evaluating the company's oral pill COVID-19 vaccine against an approved mRNA comparator. The study enrolled 201 participants who received Vaxart's oral pill vaccine and 199 who received an injectable mRNA vaccine targeting the XBB strain of SARS-CoV-2, with no vaccine-related serious adverse events or sustained Grade 3 or higher adverse events reported in either arm. Among oral pill recipients, the most common adverse events were malaise or fatigue at 20.9%, headache at 18.9%, and anorexia at 10.0%, while fewer than 10% experienced any other side effects. In the mRNA group, injection site pain occurred in 60.3%, injection site tenderness in 40.2%, malaise or fatigue in 35.2%, myalgia or muscle pain in 33.2%, and headache in 28.6%, with additional events such as chills, nausea, and diarrhea occurring in 10 to 15% of participants. Symptomatic COVID cases were reported in 33 participants in the oral pill arm and 30 in the mRNA arm, while asymptomatic cases were evenly distributed at 12 per group, though the sentinel cohort was not powered to assess comparative efficacy. Data from the full study, including approximately 5,000 participants in the main cohort, are expected in 2027, and this cohort is designed to statistically compare safety and efficacy outcomes between the oral pill and mRNA vaccine.