Moderna's Flu Vaccine Application Rejected by FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5 days ago
0mins
Should l Buy MRNA?
Source: CNBC
- Application Rejection: The FDA's refusal to review Moderna's experimental flu vaccine mRNA-1010 led to a roughly 7% drop in after-hours trading, indicating a direct financial impact from tightening regulatory environments.
- Design Controversy: The FDA raised concerns about the clinical trial design, stating that comparing the vaccine to a standard flu shot did not meet the best available standard of care, which contradicts previous feedback and may undermine market confidence in Moderna.
- Future Outlook: Despite the review hurdles, Moderna expects its flu vaccine to receive approval by late 2026 or 2027, demonstrating the company's ongoing confidence in future market opportunities, particularly in combination vaccine development.
- Regulatory Environment Shift: This incident highlights significant changes in U.S. vaccine regulatory policies under Robert F. Kennedy Jr., which could have long-term implications for Moderna and other vaccine developers' innovation capabilities.
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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: 40.110
Low
17.00
Averages
32.47
High
63.00
Current: 40.110
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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- Lawsuit Initiated: Several medical groups, including the American Academy of Pediatrics and the American Public Health Association, filed a lawsuit on Friday to prevent the CDC from holding its next vaccine advisory meeting, arguing that the CDC's overhaul of immunization guidelines could jeopardize public health.
- Vaccine Policy Changes: Under Secretary of Health and Human Services Robert F. Kennedy Jr., the CDC recommended earlier this year a significant reduction in the number of diseases covered by the childhood immunization schedule from 17 to 11, raising widespread concerns about the implications for public health.
- Committee Restructuring: Kennedy's abrupt dismissal of all 17 members of the CDC’s Advisory Committee on Immunization Practices in June, followed by the appointment of critics of mRNA vaccines, is viewed as a major interference in vaccine policy that could affect medical practices.
- Public Health Risks: Attorney James Oh stated that this policy change poses a “clear and present danger” to public health and could undermine the functions and missions of healthcare organizations, with Judge Murphy acknowledging the need for a timely decision in this case.
See More
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See More
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- Market Sentiment Recovery: The rise in health care stocks may be correlated with a broader market recovery trend, as investors reassess the investment value of the health care sector after recent volatility, indicating optimism about future growth potential.
- Increased Investor Attention: With ongoing innovations and policy support in the health care industry, investor attention towards health care stocks has significantly increased, potentially attracting more capital into the sector and driving stock prices higher.
- Optimistic Industry Outlook: The growth potential and stability of the health care sector make it attractive amid economic uncertainties, leading investors to view it as a safe haven, further propelling the upward trend in health care stocks.
See More
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- Revenue and Cost Control: Moderna reported total revenues of $1.9 billion for 2025, with Q4 revenue at $700 million, reflecting a decline from the previous quarter primarily due to reduced COVID vaccine sales; simultaneously, operating expenses were cut by $2.2 billion, showcasing significant achievements in cost management.
- Strategic Partnerships and Product Launches: The company secured a five-year strategic agreement with Mexico for respiratory vaccine supply and a global commercialization deal with Recordati, indicating proactive efforts in international market expansion and new product launches.
- R&D and Financial Outlook: Moderna anticipates revenue growth of up to 10% in 2026, primarily driven by international markets, with projected R&D expenses of $3 billion, reflecting ongoing commitment and confidence in new product development.
- Regulatory Challenges and Market Response: In light of the FDA's refusal-to-file letter regarding the flu vaccine, management acknowledged the regulatory uncertainty in the U.S. as a significant challenge, leading analysts to express concerns about the sustainability of future revenues, which reflects a cautious market sentiment regarding the company's outlook.
See More
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- Moderna's Positive Outlook: Moderna anticipates a revenue growth of up to 10% by 2025, surpassing the FactSet consensus of 5.9%, despite reporting a narrower fourth-quarter loss of $2.11 per share compared to the expected $2.54, indicating resilience in its market position.
- Maplebear's Strong Performance: Maplebear's Instacart forecasts gross transaction value between $10.13 billion and $10.28 billion for the current quarter, exceeding the $9.97 billion StreetAccount estimate, while adjusted EBITDA is expected to be between $280 million and $290 million, reflecting improved profitability.
- Wendy's Earnings Beat: Wendy's reported adjusted earnings of 16 cents per share and revenue of $543 million for the fourth quarter, both exceeding FactSet expectations, demonstrating its sustained competitiveness in the fast-food market.
- Rivian's Upgraded Delivery Forecast: Rivian projects vehicle deliveries of 62,000 to 67,000 units in 2026, representing a 47% to 59% increase from 2025, and despite a fourth-quarter adjusted loss of 54 cents per share, revenue of $1.29 billion surpassed estimates, indicating strong market demand.
See More
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- Positive Growth Outlook: The company maintains an optimistic growth outlook for 2026, anticipating continued benefits from increased vaccine demand, particularly in emerging markets, which could drive long-term revenue growth.
- Regulatory Challenges: However, the FDA's refusal of Moderna's flu vaccine application raises concerns about the company's vaccine product line, potentially impacting future sales forecasts.
- Market Reaction: Despite facing regulatory challenges, Moderna's overall performance remains robust, and investors should monitor how the company addresses FDA feedback and the progress of future vaccine development.
See More
