Moderna's Flu Vaccine Application Accepted by FDA for Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 18 2026
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Should l Buy MRNA?
Source: Newsfilter
Moderna's shares rose 7.22% as the stock reached a 20-day high, reflecting investor optimism following the FDA's acceptance of its flu vaccine application for review.
The FDA's decision to review Moderna's experimental mRNA flu vaccine marks a significant turnaround, as it had previously rejected the application. This move is seen as a critical step toward making the vaccine available, particularly for adults aged 50 to 64, with an accelerated approval plan for those 65 and older. The positive market reaction indicates strong investor confidence in Moderna's future potential in the flu vaccine market, especially with the upcoming flu season.
This development not only enhances Moderna's position in the vaccine market but also reflects a broader shift in regulatory policy that could favor innovative vaccine solutions. Investors are likely to keep a close eye on the company's progress as it navigates the approval process.
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Analyst Views on MRNA
Wall Street analysts forecast MRNA stock price to fall
20 Analyst Rating
1 Buy
16 Hold
3 Sell
Hold
Current: 52.845
Low
17.00
Averages
32.47
High
63.00
Current: 52.845
Low
17.00
Averages
32.47
High
63.00
About MRNA
Moderna, Inc. is a biotechnology company. The Company is advancing a new class of medicines made of messenger ribonucleic acid (mRNA). It is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a spectrum of diseases. The Company’s diverse development pipeline consists of 44 therapeutic and vaccine programs, 11 of which are in late-stage development. Its commercial products include Spikevax (its COVID vaccine) and mRESVIA (its respiratory syncytial virus (RSV) vaccine). Additionally, it has achieved four positive Phase III data readouts for its COVID vaccine (mRNA-1283), its RSV vaccine for high-risk adults aged 18 to 59 (mRNA-1345), its seasonal flu+COVID vaccine (mRNA-1083), and its seasonal flu vaccine (mRNA-1010).
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.
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- Settlement Amount: Moderna has agreed to pay $950 million upfront and potentially an additional $1.3 billion, totaling $2.25 billion, reflecting the financial pressure the company faces in patent litigation.
- Payment Timeline: The initial $950 million payment is scheduled for July 2026, while the additional $1.3 billion is contingent on a favorable appellate ruling regarding Section 1498 of U.S. law, which could impact the company's future cash flow and financial planning.
- Technology Licensing Agreement: As part of the settlement, Genevant will grant Moderna a global non-exclusive license to use lipid nanoparticle delivery technology for infectious disease applications, enhancing Moderna's technological capabilities in vaccine development.
- Litigation Resolution: This settlement concludes all litigation related to the COVID-19 vaccine, allowing Moderna to focus on its core business without the burden of ongoing patent-related legal risks.
See More
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- Patent Litigation Settlement: Moderna announced a settlement agreement with Arbutus Biopharma and Genevant Sciences that resolves all global litigation related to Spikevax and mRESVIA, eliminating uncertainty and allowing the company to focus on future product development.
- Financial Implications: Under the agreement, Moderna will make a lump sum payment of $950 million in Q3, and if its government contractor immunity defense is successful, no further payments will be owed; otherwise, it may face an additional payment of up to $1.3 billion within 90 days.
- Cash Forecast Adjustment: Moderna now expects to end 2026 with $4.5 billion to $5 billion in cash and cash equivalents, down from a prior forecast of $5.5 billion to $6 billion, reflecting the financial impact of the settlement agreement.
- Stock Price Surge: Following the settlement announcement, Moderna shares rose 10.23% in after-hours trading to $54.93, indicating increased market confidence in the company's future prospects.
See More
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- High Put Option Activity: Within Flex LNG, the $25 strike put option saw 849 contracts traded today, equating to approximately 84,900 shares, suggesting investor expectations of potential price declines, which could impact the company's stock price trajectory.
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- High Call Option Activity: For Moderna, the $57 strike call option recorded 6,594 contracts traded today, amounting to approximately 659,400 shares, indicating investor optimism regarding future price increases, which may drive the company's stock price higher.
See More
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Geopolitical Concerns: Ongoing geopolitical issues, including tensions related to Iran and international trade, are impacting market sentiment.
Tech Sector Pressures: The tech sector is facing challenges, particularly due to concerns surrounding artificial intelligence.
Investor Behavior: Instead of withdrawing from equities, investors are shifting their focus within the market.
Market Opportunities: This rotation in investment strategy is creating new pockets of opportunity for investors.
See More
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- Vaccine Approval Recommendation: The European Medicines Agency has recommended marketing authorization for Moderna's combined COVID-19 and influenza vaccine, mCombriax, highlighting its significance for the elderly population.
- Clinical Trial Data: The recommendation is based on data from 8,000 individuals aged 50 and older, demonstrating that antibody levels against flu and SARS-CoV-2 were non-inferior to those receiving the COVID vaccine Spikevax and flu vaccines Fluzone HD or Fluarix, indicating its efficacy.
- Market Potential: Targeting individuals aged 50 and older, mCombriax addresses the dual protection needs of the elderly, which is expected to drive further growth for Moderna in the vaccine market.
- Regulatory Dynamics: Although Moderna withdrew its application with the US FDA in May 2025, the EMA's recommendation may pave the way for future global market promotion of the vaccine.
See More
MODERNA EXPECTS BROADER ACCESS TO MCOMBRIAX IN THE EU BY 2027
Moderna's Anticipated Expansion: Moderna is planning to make its mRNA vaccine, Comirnaty, more widely available by 2027.
Focus on Accessibility: The company aims to enhance the distribution and accessibility of its vaccine to a broader population.
See More
