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Shares of Moderna (MRNA) jumped 4% on Thursday morning before paring gains after the U.S. Food and Drug Administration approved mFLUSIVA, a seasonal influenza vaccine for adults 50 and older, validating its mRNA-based approach for uses beyond COVID treatment.
At the time of writing, the stock pared some of the gains and was trading 3% lower.
The approval makes mFLUSIVA Moderna’s fourth FDA-cleared product and the first messenger RNA-based flu vaccine. It is authorized for all adults aged 50 and up. For those 50-64, full approval rests on a large late-stage trial involving more than 40,000 people that compared it to a standard flu shot. For adults 65 and older, the FDA granted it accelerated approval, meaning the firm will conduct confirmatory studies to validate efficacy and ensure a full, traditional approval.
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CEO Stéphane Bancel called the decision proof of the mRNA platform’s strength. “Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors,” he said.
Moderna expects doses to reach select U.S. retailers in the coming weeks for the 2026-2027 season. It will sit alongside the company’s COVID-19 and Respiratory Syncytial Virus vaccines.
The company is also seeking approval for the vaccine in the European Union, Canada, and Australia, with more filings planned this year.
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Moderna first filed for approval of the vaccine in December, but in February, the agency refused to review the application, citing the use of a regular flu shot for comparison instead of a stronger version preferred for seniors.
Moderna quickly revised its request to seek full approval for ages 50–64 and a faster track for those 65 and older. The FDA accepted the updated filing within days and set an August decision date.
After the COVID-19 pandemic propelled Moderna’s vaccine sales to a peak of more than $18 billion in 2022, demand collapsed, driving annual revenue down to roughly $1.9 billion by 2025. In response, the company sharply cut costs, reduced its workforce, and discontinued several early programs, while shifting strategy to build a steady seasonal respiratory franchise—including flu, RSV, and combination shots.
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The company is now targeting a more diversified portfolio and cash breakeven by 2028
On Stocktwits, retail sentiment around MRNA stock stayed within the ‘bullish’ territory over the past 24 hours, while message volume rose from ‘normal’ to ‘high’ levels.
A Stocktwits user highlighted that the company now has multiple FDA-approved products.
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“That's a real pipeline, not just a COVID story anymore,” they wrote, while also expressing anticipation about the product’s launch curve.
Another user expressed disappointment over the stock paring its gains but maintained optimism for the stock in the long term, citing efforts in cancer therapy development. Moderna is attempting a vaccine for melanoma patients.
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MRNA stock has gained 85% year-to-date.
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