FDA Agrees to Review Moderna's Flu Vaccine
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 18 2026
0mins
Should l Buy MRNA?
Source: Yahoo Finance
- Regulatory Shift: The FDA's decision to assess Moderna's seasonal flu vaccine mRNA-1010 through a two-pronged approach signifies a major policy change following a meeting with Moderna, potentially accelerating the vaccine's market entry.
- Segmented Evaluation Strategy: The FDA will evaluate the vaccine separately for adults aged 50-64 and those 65 and older, allowing for an accelerated approval pathway for the older demographic, thus providing Moderna with a more flexible market access route.
- Optimistic Market Outlook: Moderna anticipates that mRNA-1010 could receive approval by the 2026/2027 flu season, which, if successful, would create a new revenue stream for the company and further solidify its position in the flu vaccine market.
- Positive Stock Reaction: Following the FDA's announcement, Moderna's stock price rose from $43.93 on February 17 to $46.70 at the opening on February 18, reflecting a 6% increase and market optimism regarding the vaccine's potential success.
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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: 50.030
Low
17.00
Averages
32.47
High
63.00
Current: 50.030
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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- Manufacturing Incentives: Drugmakers can reduce or avoid tariffs by relocating production to the U.S. or negotiating deals with the administration, aiming to stimulate domestic manufacturing and potentially leading to a resurgence of investments in the pharmaceutical sector.
- Tariff Implementation Details: The draft proposal includes a 20% tariff for companies planning to onshore production, escalating to 100% in four years, which could significantly influence the long-term strategic positioning of the pharmaceutical industry.
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- Earnings Expectations: The company is projected to report an EPS of -$2.03, representing a 19.44% increase year-over-year, with quarterly revenue expected at $229.96 million, up 112.92% from the same period last year, highlighting significant revenue growth potential.
- Analyst Confidence: Recent adjustments to analyst earnings estimates for Moderna, despite a 1.69% decrease in the consensus EPS projection over the past month, typically indicate confidence in the company's future performance, which could influence short-term stock movements.
- Industry Ranking: Moderna operates within the Biomedical and Genetics industry, currently ranked 148 by Zacks, placing it in the bottom 40% of over 250 industries, suggesting overall underperformance that may negatively impact Moderna's market position.
See More
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- High Call Option Activity: Within Moderna, the $53 strike call option has seen particularly high activity, with 17,074 contracts traded today, representing about 1.7 million shares, suggesting investor confidence in the stock's upward potential.
- Kodak Options Trading Overview: Eastman Kodak Co's options volume stands at 11,915 contracts, approximately 1.2 million shares, which is 108.2% of its average daily trading volume over the past month, reflecting market interest in its potential volatility.
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See More
Investment Outlook for Healthcare Stocks
- Moderna's mRNA Platform: Moderna's mRNA vaccines are favored for their rapid production and strong immune responses, particularly with its flu vaccine seeking U.S. approval, which is expected to enhance market competitiveness and drive future growth.
- Personalized Cancer Vaccine Progress: The mRNA-4157, developed in partnership with Merck, shows promising results in significantly reducing recurrence or death risk in advanced melanoma patients, with five-year follow-up data indicating optimistic clinical prospects that could sustain stock price growth over the next five years.
- Abivax's Innovative Drug: Abivax's obefazimod demonstrates excellent efficacy in treating ulcerative colitis, with clinical trials showing that 47.3% of patients previously unresponsive to traditional treatments could benefit, positioning the company to challenge market giants and achieve sales growth if approved.
- Market Competition and Risks: While Abivax faces fierce competition from large pharmaceutical companies, the unique advantages of obefazimod may allow it to capture market share over the next five years; however, the risks associated with clinical trials require cautious consideration from investors.
See More
Biotech Companies Show Promising Clinical Progress
- Moderna's mRNA Platform: Moderna's mRNA vaccines are produced faster than traditional vaccines and elicit stronger immune responses, with shares up 73% in 2023, indicating potential for continued growth over the next five years despite clinical and regulatory risks.
- Personalized Cancer Vaccine: The mRNA-4157 candidate, when combined with Keytruda, significantly reduced recurrence or death risk in advanced melanoma patients, showcasing its potential across various cancer types and likely enhancing future market performance for Moderna.
- Abivax's Innovative Drug: Abivax's obefazimod achieved its primary endpoint of clinical remission in a phase 3 trial, with 47.3% of patients previously treated unsuccessfully, positioning it as a strong competitor in the ulcerative colitis market, challenging established players if approved.
- Market Potential and Risks: If Abivax secures approval for obefazimod and expands into related conditions, its sales could soar over the next five years, but investors should remain cautious of potential clinical trial setbacks that could impact stock performance.
See More
