Moderna's Flu Vaccine Receives FDA Review Approval
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 18 2026
0mins
Source: CNBC
- FDA Review Decision: The FDA's agreement to review Moderna's experimental mRNA flu vaccine reverses its earlier refusal, stunning Wall Street and the medical community, marking a significant advancement in vaccine development.
- Positive Market Reaction: Following the FDA review announcement, Moderna's shares rose over 6%, reflecting investor confidence in the company's future flu vaccine market potential and paving the way for its goal of breaking even by 2028.
- New Application Strategy: Moderna's revised regulatory approach seeks full approval for adults aged 50 to 64 and accelerated approval for those 65 and older, addressing FDA criticisms of its trial design and enhancing the vaccine's market competitiveness.
- Changing Regulatory Environment: The FDA's decision highlights significant shifts in U.S. vaccine regulatory policies, particularly under the leadership of the new Secretary of Health and Human Services, with Moderna's application process facing stricter scrutiny, illustrating the complexities and challenges of vaccine regulation.
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Analyst Views on MRNA
Wall Street analysts forecast MRNA stock price to fall
20 Analyst Rating
1 Buy
16 Hold
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Hold
Current: 63.960
Low
17.00
Averages
32.47
High
63.00
Current: 63.960
Low
17.00
Averages
32.47
High
63.00
About MRNA
Moderna, Inc. is a biotechnology company advancing a new class of medicines made of messenger ribonucleic acid (mRNA). It is engaged in developing medicines across infectious disease vaccines, oncology therapeutics and rare disease therapeutics. Its platform incorporates advances across three components, mRNA, delivery, and the manufacturing process, to advance its medicines. Its products are Spikevax and mNEXSPIKE (its COVID vaccines), and mRESVIA (its vaccine against respiratory syncytial virus (RSV)). It also has a diverse development pipeline that consists of 35 therapeutic and vaccine programs, six of which are in late-stage development. It has regulatory filings under review for its seasonal flu+COVID vaccine (mRNA-1083) in Europe and Canada and for its seasonal flu vaccine (mRNA-1010) in the United States, Europe, Canada and Australia. Its rare disease programs are Propionic acidemia (mRNA-3927); Methylmalonic acidemia (mRNA-3705), and Cystic Fibrosis (mRNA-3692/VX-522).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Moderna Stock Doubles as Key Turning Point Approaches
- Stock Surge: Moderna's stock has soared over 100% since the beginning of 2023, indicating a renewed investor confidence in the company's future potential, particularly after a decline in vaccine demand, showcasing a recovery in market sentiment.
- Vaccine Candidate Progress: The company is advancing its flu vaccine candidate mRNA-1010, which received unanimous support from an FDA advisory panel, with expectations for a launch in the 2026-2027 flu season, potentially providing new revenue streams for Moderna.
- Strong Pipeline: Despite setbacks with its CMV vaccine in late-stage trials, Moderna's mRNA technology remains promising, with plans to launch multiple new products, including flu and coronavirus vaccines, further solidifying its market position.
- Investor Confidence Rebounds: With the company's positive developments in the vaccine sector, investor confidence in Moderna is gradually returning, and following the FDA's final decision on August 5, the stock price may rise again, attracting more investor interest.
See More
Moderna's Vaccine Prospects Look Promising
- Stock Recovery: Moderna's stock has surged over 100% since the beginning of the year, reflecting a renewed investor confidence in the company's future potential, particularly against the backdrop of declining vaccine demand, indicating strong market belief in its mRNA technology.
- Product Launch Plans: The company aims to release three new vaccines between 2027 and 2028, including a combination flu and coronavirus vaccine, which will not only diversify its product line but also potentially create new revenue streams, enhancing its competitive position in the market.
- FDA Review Progress: The U.S. FDA advisory panel unanimously supported Moderna's flu vaccine candidate mRNA-1010, with a decision expected by August 5, which could pave the way for a market launch in the 2026-2027 flu season, marking a significant milestone for the company.
- Optimistic Market Outlook: Despite some risks, Moderna is accelerating its transition to a multi-product commercial stage, with investors eagerly anticipating future revenue drivers, especially following potential vaccine approvals, which may present opportunities for stock price increases.
See More
Moderna Stock Pulls Back but Remains Strong Performer
- Stock Pullback: Moderna's shares fell 6.10% to $60.06 on Monday, ending a six-session winning streak; however, the stock has been a standout performer recently, surging over 39% in the last six sessions, significantly outpacing the S&P 500's 3.2% gain.
- Impressive Year-to-Date Performance: As of 2026, Moderna's stock has climbed over 100.7%, compared to a mere 9.8% increase in the benchmark index, highlighting its strong market performance and investor confidence.
- Vaccine Approval Boost: The FDA advisory committee's recommendation for the approval of Moderna's seasonal influenza vaccine for adults aged 50 and older has bolstered investor optimism regarding the company's vaccine portfolio, contributing to the recent stock rally.
- Production Expansion Potential: Reports indicate that Moderna is evaluating production facilities in Germany that BioNTech plans to shut down, which could allow the company to expand its manufacturing capacity by leveraging existing infrastructure, thereby enhancing its competitive position in the market.
See More
Moderna's Diversification Strategy Boosts Stock Recovery
- Vaccine Development Progress: Moderna is aggressively developing its mFlusiva seasonal influenza vaccine, which performed well in phase 3 trials, with the FDA's decision expected on August 5; if approved, it could provide a new revenue stream for the 2026-2027 flu season.
- Cancer Vaccine Innovation: The personalized cancer vaccine intismeran (mRNA-4157), developed in partnership with Merck, shows promising sustained efficacy in high-risk melanoma patients, with pivotal phase 3 data expected later this year, potentially opening new market opportunities for Moderna.
- Commercial Expansion Plans: Moderna aims to launch up to three new products between 2027 and 2028, including a novel norovirus vaccine and treatments for rare diseases, recently appointing a new chief commercial officer to drive successful global launches, reflecting confidence in future growth.
- Financial Status Analysis: Despite reporting $389 million in revenue for Q1, a 260% year-over-year increase, the company faced a $3.40 EPS loss due to a one-time litigation charge; however, with $7.5 billion in cash, Moderna has a comfortable runway to achieve its goal of breakeven by 2028.
See More
Moderna Reports 260% Revenue Growth in Q1, Expands mRNA Applications
- Significant Revenue Growth: Moderna reported $389 million in revenue for Q1, marking a 260% year-over-year increase, demonstrating the company's successful diversification despite challenges from declining COVID-19 vaccine sales.
- Vaccine Development Progress: The mFlusiva seasonal influenza vaccine performed well in phase 3 trials, with the FDA's decision expected on August 5; if approved, it could provide a significant boost to the company's market share for the 2026-2027 flu season.
- Cancer Vaccine Development: The personalized cancer vaccine intismeran (mRNA-4157), developed in partnership with Merck, showed sustained efficacy in high-risk melanoma patients, with pivotal phase 3 data readouts expected later this year, potentially redefining the company's valuation.
- Financial Status and Risks: Despite reporting a Q1 EPS loss of $3.40, Moderna maintains $7.5 billion in cash and low debt levels, providing a solid financial runway for upcoming product launches, with a goal of achieving overall breakeven by 2028.
See More
Moderna's Progress in Vaccine Diversification
- Vaccine Diversification Strategy: Moderna is aggressively expanding its vaccine portfolio, particularly with the mFlusiva vaccine for influenza, which performed well in phase 3 trials, with the FDA expected to make a decision by August 5; if approved, it could provide a new option for the 2026-2027 flu season, significantly enhancing the company's competitive position in the vaccine market.
- Personalized Cancer Vaccine Development: The individualized cancer vaccine intismeran (mRNA-4157), developed in partnership with Merck, has shown promising efficacy in high-risk melanoma patients, with pivotal phase 3 data expected later this year, which could redefine the company's valuation outlook.
- Commercial Expansion Plans: Moderna plans to launch up to three new products between 2027 and 2028, including a novel norovirus vaccine and treatments for rare diseases, with a newly appointed chief commercial officer overseeing global launches, reflecting the company's confidence in future growth.
- Financial Status and Risks: Despite a 260% year-over-year revenue increase to $389 million in Q1, the company reported an EPS loss of $3.40, primarily due to a one-time litigation loss; however, with $7.5 billion in cash and low debt levels, Moderna is well-positioned for future development and achieving breakeven by 2028.
See More
Moderna Stock Doubles as Key Turning Point Approaches
- Stock Surge: Moderna's stock has soared over 100% since the beginning of 2023, indicating a renewed investor confidence in the company's future potential, particularly after a decline in vaccine demand, showcasing a recovery in market sentiment.
- Vaccine Candidate Progress: The company is advancing its flu vaccine candidate mRNA-1010, which received unanimous support from an FDA advisory panel, with expectations for a launch in the 2026-2027 flu season, potentially providing new revenue streams for Moderna.
- Strong Pipeline: Despite setbacks with its CMV vaccine in late-stage trials, Moderna's mRNA technology remains promising, with plans to launch multiple new products, including flu and coronavirus vaccines, further solidifying its market position.
- Investor Confidence Rebounds: With the company's positive developments in the vaccine sector, investor confidence in Moderna is gradually returning, and following the FDA's final decision on August 5, the stock price may rise again, attracting more investor interest.
See More
Moderna's Vaccine Prospects Look Promising
- Stock Recovery: Moderna's stock has surged over 100% since the beginning of the year, reflecting a renewed investor confidence in the company's future potential, particularly against the backdrop of declining vaccine demand, indicating strong market belief in its mRNA technology.
- Product Launch Plans: The company aims to release three new vaccines between 2027 and 2028, including a combination flu and coronavirus vaccine, which will not only diversify its product line but also potentially create new revenue streams, enhancing its competitive position in the market.
- FDA Review Progress: The U.S. FDA advisory panel unanimously supported Moderna's flu vaccine candidate mRNA-1010, with a decision expected by August 5, which could pave the way for a market launch in the 2026-2027 flu season, marking a significant milestone for the company.
- Optimistic Market Outlook: Despite some risks, Moderna is accelerating its transition to a multi-product commercial stage, with investors eagerly anticipating future revenue drivers, especially following potential vaccine approvals, which may present opportunities for stock price increases.
See More
Moderna Stock Pulls Back but Remains Strong Performer
- Stock Pullback: Moderna's shares fell 6.10% to $60.06 on Monday, ending a six-session winning streak; however, the stock has been a standout performer recently, surging over 39% in the last six sessions, significantly outpacing the S&P 500's 3.2% gain.
- Impressive Year-to-Date Performance: As of 2026, Moderna's stock has climbed over 100.7%, compared to a mere 9.8% increase in the benchmark index, highlighting its strong market performance and investor confidence.
- Vaccine Approval Boost: The FDA advisory committee's recommendation for the approval of Moderna's seasonal influenza vaccine for adults aged 50 and older has bolstered investor optimism regarding the company's vaccine portfolio, contributing to the recent stock rally.
- Production Expansion Potential: Reports indicate that Moderna is evaluating production facilities in Germany that BioNTech plans to shut down, which could allow the company to expand its manufacturing capacity by leveraging existing infrastructure, thereby enhancing its competitive position in the market.
See More
Moderna's Diversification Strategy Boosts Stock Recovery
- Vaccine Development Progress: Moderna is aggressively developing its mFlusiva seasonal influenza vaccine, which performed well in phase 3 trials, with the FDA's decision expected on August 5; if approved, it could provide a new revenue stream for the 2026-2027 flu season.
- Cancer Vaccine Innovation: The personalized cancer vaccine intismeran (mRNA-4157), developed in partnership with Merck, shows promising sustained efficacy in high-risk melanoma patients, with pivotal phase 3 data expected later this year, potentially opening new market opportunities for Moderna.
- Commercial Expansion Plans: Moderna aims to launch up to three new products between 2027 and 2028, including a novel norovirus vaccine and treatments for rare diseases, recently appointing a new chief commercial officer to drive successful global launches, reflecting confidence in future growth.
- Financial Status Analysis: Despite reporting $389 million in revenue for Q1, a 260% year-over-year increase, the company faced a $3.40 EPS loss due to a one-time litigation charge; however, with $7.5 billion in cash, Moderna has a comfortable runway to achieve its goal of breakeven by 2028.
See More
Moderna Reports 260% Revenue Growth in Q1, Expands mRNA Applications
- Significant Revenue Growth: Moderna reported $389 million in revenue for Q1, marking a 260% year-over-year increase, demonstrating the company's successful diversification despite challenges from declining COVID-19 vaccine sales.
- Vaccine Development Progress: The mFlusiva seasonal influenza vaccine performed well in phase 3 trials, with the FDA's decision expected on August 5; if approved, it could provide a significant boost to the company's market share for the 2026-2027 flu season.
- Cancer Vaccine Development: The personalized cancer vaccine intismeran (mRNA-4157), developed in partnership with Merck, showed sustained efficacy in high-risk melanoma patients, with pivotal phase 3 data readouts expected later this year, potentially redefining the company's valuation.
- Financial Status and Risks: Despite reporting a Q1 EPS loss of $3.40, Moderna maintains $7.5 billion in cash and low debt levels, providing a solid financial runway for upcoming product launches, with a goal of achieving overall breakeven by 2028.
See More
Moderna's Progress in Vaccine Diversification
- Vaccine Diversification Strategy: Moderna is aggressively expanding its vaccine portfolio, particularly with the mFlusiva vaccine for influenza, which performed well in phase 3 trials, with the FDA expected to make a decision by August 5; if approved, it could provide a new option for the 2026-2027 flu season, significantly enhancing the company's competitive position in the vaccine market.
- Personalized Cancer Vaccine Development: The individualized cancer vaccine intismeran (mRNA-4157), developed in partnership with Merck, has shown promising efficacy in high-risk melanoma patients, with pivotal phase 3 data expected later this year, which could redefine the company's valuation outlook.
- Commercial Expansion Plans: Moderna plans to launch up to three new products between 2027 and 2028, including a novel norovirus vaccine and treatments for rare diseases, with a newly appointed chief commercial officer overseeing global launches, reflecting the company's confidence in future growth.
- Financial Status and Risks: Despite a 260% year-over-year revenue increase to $389 million in Q1, the company reported an EPS loss of $3.40, primarily due to a one-time litigation loss; however, with $7.5 billion in cash and low debt levels, Moderna is well-positioned for future development and achieving breakeven by 2028.
See More
