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MRNA Stock Jumps on Global Submissions Seeking Nod for Flu Vaccine
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Key Takeaways
Moderna filed for approval of its seasonal flu vaccine mRNA-1010 in the US, EU, Canada and Australia.
MRNA said late-stage data show mRNA-1010 immune responses match standard and high-dose flu shots.
The filings could also support a potential future resubmission of its COVID-flu combo vaccine.
Moderna (MRNA - Free Report) announced that it submitted regulatory filings seeking approval for its seasonal influenza vaccine mRNA-1010 across the United States, European Union, Canada and Australia.
These filings seek marketing authorization for using the shot in adults aged 50 years and above. If approved, Moderna intends to commercialize this vaccine by next year, marking a key step in expanding its non-COVID product portfolio beyond the RSV vaccine mResvia.
These submissions are based on data from multiple late-stage studies. Collectively, this data shows 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) .
Like its other marketed products, the vaccine is built using Moderna’s mRNA technology.
MRNA Stock Price Performance
Post the above announcement, shares of Moderna rose more than 4% on Monday. Investors likely cheered the move, as it highlighted the company's step toward a potential product launch.
This recent development has also raised hope for mRNA-1083, an investigational combination vaccine against COVID-19 and influenza. Although a filing was initially submitted for this vaccine, it was withdrawn by Moderna in May 2025 after the agency requested additional efficacy data for the flu component.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 also 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.
Shares of the company have lost 32% in the past year against the industry’s 15% growth.
Image Source: Zacks Investment Research
Is Moderna’s Stock Set for Rebound?
Some investors view this latest development as part of the company’s broader effort to reverse negative sentiment surrounding the stock.
Over the past couple of years, Moderna has been facing pressure from the persistently declining sales performance of its COVID-19 vaccine, the soft sales performance of 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 also 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.
Image: Bigstock
MRNA Stock Jumps on Global Submissions Seeking Nod for Flu Vaccine
Key Takeaways
Moderna (MRNA - Free Report) announced that it submitted regulatory filings seeking approval for its seasonal influenza vaccine mRNA-1010 across the United States, European Union, Canada and Australia.
These filings seek marketing authorization for using the shot in adults aged 50 years and above. If approved, Moderna intends to commercialize this vaccine by next year, marking a key step in expanding its non-COVID product portfolio beyond the RSV vaccine mResvia.
These submissions are based on data from multiple late-stage studies. Collectively, this data shows 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) .
Like its other marketed products, the vaccine is built using Moderna’s mRNA technology.
MRNA Stock Price Performance
Post the above announcement, shares of Moderna rose more than 4% on Monday. Investors likely cheered the move, as it highlighted the company's step toward a potential product launch.
This recent development has also raised hope for mRNA-1083, an investigational combination vaccine against COVID-19 and influenza. Although a filing was initially submitted for this vaccine, 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 also 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.
Shares of the company have lost 32% in the past year against the industry’s 15% growth.
Image Source: Zacks Investment Research
Is Moderna’s Stock Set for Rebound?
Some investors view this latest development as part of the company’s broader effort to reverse negative sentiment surrounding the stock.
Over the past couple of years, Moderna has been facing pressure from the persistently declining sales performance of its COVID-19 vaccine, the soft sales performance of 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 also 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.