Moderna Shares Drop 10% After FDA Refusal on Flu Shot Application
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 11 2026
0mins
Should l Buy MRNA?
Source: CNBC
Moderna's shares fell 10% after the FDA refused to review its application for the experimental flu shot mRNA-1010, prompting the company to request a meeting with the FDA to clarify the path forward, which could impact its vaccine development and market confidence.
The FDA's refusal to review Moderna's application for mRNA-1010 has raised concerns about the company's future in the vaccine market, leading to a significant drop in stock price. This decision contradicts previous expectations and has left investors uncertain about the company's next steps in vaccine development.
The implications of this FDA decision could be profound for Moderna, as it may hinder the company's ability to compete in the seasonal flu vaccine market, affecting investor confidence and future revenue streams.
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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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- 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.
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- 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.
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