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Moderna Stock Jumps After FDA Reverses Course on Flu Shot
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Key Takeaways
Moderna shares climbed 6% after the FDA agreed to review its mRNA-1010 flu vaccine filing.
FDA reversed last week's refusal; decision on mRNA-1010 is due by Aug. 5, 2026.
mRNA-1010 seeks full nod for 50-64 and accelerated approval for 65, launch eyed for 2026/2027.
Shares of Moderna (MRNA - Free Report) rose 6% on Wednesday after the company announced that the FDA agreed to review its regulatory filing seeking approval for its seasonal influenza vaccine, mRNA-1010. A final decision is expected by Aug. 5, 2026.
This announcement surprised investors, as last week the agency had refused to review the regulatory filing for mRNA-1010. Per the FDA, the late-stage study supporting the filing was not adequate and well-controlled because the licensed standard-dose seasonal influenza vaccine that Moderna used as the comparator was not “the best-available standard of care.”
In a recently held type A meeting with the FDA, Moderna has proposed a regulatory pathway for mRNA-1010’s approval, based on age. The regulatory filing has been modified, which now seeks full approval for the vaccine in adults aged 50-64 years and an accelerated approval for adults aged 65 years and above.
If approved, Moderna intends to commercially launch mRNA-1010 for the 2026/2027 vaccination season. As part of post-marketing requirements, the company will conduct an additional study evaluating this vaccine in older adults.
The filing is supported by data from multiple late-stage studies, which show that the immune responses generated by mRNA-1010 are at least as effective as those from currently available standard and high-dose flu shots marketed by GSK plc (GSK - Free Report) and Sanofi (SNY - Free Report) . Similar filings for the vaccine have also been submitted by Moderna in Europe, Canada and Australia, all of which are currently under regulatory review.
Like Moderna’s other marketed products, the vaccine is built using its mRNA technology.
MRNA Stock Price Performance
Shares of Moderna rose on Wednesday as investors cheered this development. The FDA’s reversal highlights the company’s progress toward a potential product launch. It also marks a key step in expanding its non-COVID portfolio beyond the RSV vaccine mResvia.
This recent development has also raised hope for mRNA-1083, an investigational combination vaccine against COVID-19 and influenza. A filing was initially submitted for this vaccine, but it was withdrawn by Moderna in May 2025 after the agency requested additional efficacy data for the flu component. This candidate integrates the company’s COVID-19 shot with mRNA-1010. This requested data has been submitted as one of the studies supporting the mRNA-1010 filing. The company is currently awaiting further guidance from the FDA for a potential filing of this vaccine.
Year to date, the stock has soared 58% compared with the industry’s 9% growth.
Image Source: Zacks Investment Research
Is Moderna’s Stock Headed Toward Recovery?
Over the past couple of years, MRNA has been facing pressure from the persistently declining sales performance of its COVID-19 vaccine, soft demand for its RSV vaccine and pipeline setbacks. Recently, the company reported that its CMV vaccine failed to meet the primary endpoint in a late-stage study. The heightened level of scrutiny against vaccines in the United States has weighed on overall vaccine demand.
Moderna has also encountered regulatory setbacks. Last year, the U.S. government terminated contracts worth $766 million awarded to the company for the late-stage development of an mRNA-based bird flu vaccine, as well as the right to purchase this vaccine. This funding loss comes at a time when Moderna is working to scale back operating expenses and streamline its R&D pipeline.
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Image: Bigstock
Moderna Stock Jumps After FDA Reverses Course on Flu Shot
Key Takeaways
Shares of Moderna (MRNA - Free Report) rose 6% on Wednesday after the company announced that the FDA agreed to review its regulatory filing seeking approval for its seasonal influenza vaccine, mRNA-1010. A final decision is expected by Aug. 5, 2026.
This announcement surprised investors, as last week the agency had refused to review the regulatory filing for mRNA-1010. Per the FDA, the late-stage study supporting the filing was not adequate and well-controlled because the licensed standard-dose seasonal influenza vaccine that Moderna used as the comparator was not “the best-available standard of care.”
In a recently held type A meeting with the FDA, Moderna has proposed a regulatory pathway for mRNA-1010’s approval, based on age. The regulatory filing has been modified, which now seeks full approval for the vaccine in adults aged 50-64 years and an accelerated approval for adults aged 65 years and above.
If approved, Moderna intends to commercially launch mRNA-1010 for the 2026/2027 vaccination season. As part of post-marketing requirements, the company will conduct an additional study evaluating this vaccine in older adults.
The filing is supported by data from multiple late-stage studies, which show that the immune responses generated by mRNA-1010 are at least as effective as those from currently available standard and high-dose flu shots marketed by GSK plc (GSK - Free Report) and Sanofi (SNY - Free Report) . Similar filings for the vaccine have also been submitted by Moderna in Europe, Canada and Australia, all of which are currently under regulatory review.
Like Moderna’s other marketed products, the vaccine is built using its mRNA technology.
MRNA Stock Price Performance
Shares of Moderna rose on Wednesday as investors cheered this development. The FDA’s reversal highlights the company’s progress toward a potential product launch. It also marks a key step in expanding its non-COVID portfolio beyond the RSV vaccine mResvia.
This recent development has also raised hope for mRNA-1083, an investigational combination vaccine against COVID-19 and influenza. A filing was initially submitted for this vaccine, but it was withdrawn by Moderna in May 2025 after the agency requested additional efficacy data for the flu component. This candidate integrates the company’s COVID-19 shot with mRNA-1010. This requested data has been submitted as one of the studies supporting the mRNA-1010 filing. The company is currently awaiting further guidance from the FDA for a potential filing of this vaccine.
Year to date, the stock has soared 58% compared with the industry’s 9% growth.
Image Source: Zacks Investment Research
Is Moderna’s Stock Headed Toward Recovery?
Over the past couple of years, MRNA has been facing pressure from the persistently declining sales performance of its COVID-19 vaccine, soft demand for its RSV vaccine and pipeline setbacks. Recently, the company reported that its CMV vaccine failed to meet the primary endpoint in a late-stage study. The heightened level of scrutiny against vaccines in the United States has weighed on overall vaccine demand.
Moderna has also encountered regulatory setbacks. Last year, the U.S. government terminated contracts worth $766 million awarded to the company for the late-stage development of an mRNA-based bird flu vaccine, as well as the right to purchase this vaccine. This funding loss comes at a time when Moderna is working to scale back operating expenses and streamline its R&D pipeline.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
MRNA’s Zacks Rank
Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.