Moderna, Inc. (NASDAQ:MRNA) shares are up nearly 5% on Tuesday after the company announced positive preliminary immunogenicity data for its 2025-2026 Spikevax formula, which targets the new LP.8.1 variant of COVID-19.
What Happened: The Phase 4 clinical trial that’s currently underway — covering the safety, tolerability and immunogenicity of the 2025-2026 Spikevax formula — showed positive results.
Overall, the data revealed that there was more than an eightfold increase in the formula’s ability to counteract antibodies against the LP.8.1 variant in those aged 12 through 64 with at least one underlying condition and those who are aged 65 or older, putting them at a higher risk of a severe outcome when coming into contact with COVID-19. There were no newly identified safety concerns regarding the vaccine throughout the trial.
The immunogenicity boost from 2025–2026 Spikevax formula provides a strong antibody response against not only the LP.8.1 variant, but also the XFG and NB.1.8.1 variants.
“Recent surveillance data from the U.S. Centers for Disease Control and Prevention (CDC) shows the U.S. wastewater viral activity for COVID-19 is high, and LP.8.1 and its familial strains, XFG and NB.1.8.1, continue to dominate,” the company said.
Moderna said the preliminary data analysis confirms the company’s updated COVID-19 vaccine is a strong match to today’s top circulating strains in the U.S.
The FDA’s nod of approval is supported by the clinical data arising from Moderna’s trial, solidifying market positioning for those who are high-risk and part of the senior population.
The company noted that Spikevax continues to gain clearance internationally, including in countries like Canada, Europe, Japan, Mexico and Switzerland.
MRNA Price Action: Moderna shares were up 4.82% at $25.03 at the time of publication on Tuesday, according to Benzinga Pro.
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