Moderna Stock Surges Pre-Market As Flu Vaccine Shows Positive Results In Late-Stage Trial

Vaccine maker Moderna, Inc. (MRNA) said on Monday that its experimental seasonal flu vaccine demonstrated strong effectiveness in a late-stage study as compared to a currently available standard-dose seasonal influenza vaccine in adults aged 50 years and older.

MRNA stock was trading 5% higher in the pre-market session on Monday.

Moderna’s candidate demonstrated vaccine efficacy that was 26.6% higher than the standard vaccine in the population, the company said.

The data is key to receiving approvals for both the individual vaccine candidate and the company’s seasonal flu-COVID combination vaccine candidate.

In May, Moderna withdrew its application to the U.S. Food and Drug Administration (FDA) for approval of its seasonal flu-COVID combination vaccine candidate.

Moderna then said that it would resubmit the application later this year once data from its late-stage trial of its seasonal flu vaccine is available. The decision to withdraw the application was in consultation with the FDA, the company then said.

The company said on Monday that it will engage with regulators to file submissions for the flu vaccine candidate, incorporating the late-stage trial data.

The late-stage trial enrolled over 40,000 adults aged 50 years and older across 11 countries. The vaccine, in addition to demonstrating better effectiveness as compared to a standard vaccine, also demonstrated strong efficacy for each of the major influenza strains in the shot, including A/H1N1, A/H3N2, and the B/Victoria lineages.

The results were consistent across age groups, risk factors, and previous influenza vaccination status, the company added.

Moderna CEO Stéphane Bancel said that the severity of the past flu season underscores the need for “more effective vaccines.”

Citing data from the U.S. national public health agency, Moderna stated that seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024-2025 season, and more than 600,000 Americans were hospitalized due to flu-related illnesses last year.

On Stocktwits, retail sentiment around Moderna improved over the past 24 hours from ‘bearish’ to ‘neutral’ territory.

MRNA stock is down by 35% this year and by about 77% over the past 12 months.

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