The trial was evaluating the safety, tolerability, and immunogenicity of the new formula of mNEXSPIKE.
Moderna (MRNA) said on Tuesday that its 2025-2026 formula of mNEXSPIKE demonstrated a strong immune response in recipients in a study.
The updated formulation targets the LP.8.1 variant of the COVID-19-causing virus. Data from an ongoing phase 4, post-marketing study showed that the updated formula of mNEXSPIKE, on average, demonstrated a greater than 16-fold increase in neutralizing antibodies against the LP.8.1 variant, the company said.
A robust immune response was identified in individuals aged 12 to 64 years with at least one underlying condition that puts them at high risk for severe outcomes from an infection, as well as in all adults aged 65 years and older, the company added. The trial was evaluating the safety, tolerability, and immunogenicity of the new formula of mNEXSPIKE.
MRNA shares rose over 1% in the pre-market session at the time of writing. On Stocktwits, retail sentiment around MRNA stayed within ‘neutral’ territory over the past 24 hours, while message volume stayed at ‘normal’ levels.
Moderna stated that the safety profile of the vaccine in the study was consistent with that observed in previous studies. mNEXSPIKE received the approval of the U.S. Food and Drug Administration in late May.
Earlier this month, the company also announced that the 2025-2026 formula of its other COVID-19 vaccine, Spikevax, showed, on average, a greater than 8-fold increase in neutralizing antibodies against the LP.8.1 variant in individuals participating in a Phase 4 study.
Spikevax is approved by the FDA for individuals six months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older. mNEXSPIKE is only approved for individuals who are at least 12 years of age.
MRNA stock is down 36% this year and approximately 59% over the past 12 months.
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