Moderna's Influenza Vaccine Application Rejected by FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
0mins
Should l Buy MRNA?
Source: seekingalpha
- Application Rejection: Moderna's biologics license application for its influenza vaccine mRNA-1010 was not reviewed by the FDA, resulting in a nearly 9% drop in shares during after-hours trading.
- Priority Review Ineffective: Despite utilizing a priority review voucher to expedite the process, the FDA indicated that the clinical trial's control arm did not reflect the best available standard of care in the U.S. at the time, undermining the application’s validity.
- No Safety or Efficacy Concerns: The refusal letter did not identify any specific safety or efficacy issues regarding mRNA-1010, suggesting that the vaccine still holds potential in these areas.
- Future Plans Unaffected: Moderna stated that the refusal will not impact its 2026 financial guidance and has requested a meeting with FDA officials to clarify the next steps.
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Analyst Views on MRNA
Wall Street analysts forecast MRNA stock price to fall over the next 12 months. According to Wall Street analysts, the average 1-year price target for MRNA is 29.36 USD with a low forecast of 17.00 USD and a high forecast of 63.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
19 Analyst Rating
1 Buy
14 Hold
4 Sell
Hold
Current: 41.950
Low
17.00
Averages
29.36
High
63.00
Current: 41.950
Low
17.00
Averages
29.36
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.
Moderna's Stock Rises Due to Pipeline Progress
- Strong Stock Performance: Moderna's shares have surged 39% in 2026, despite the absence of recent financial results, indicating market confidence in its future potential ahead of the upcoming Q4 2025 earnings report.
- Pipeline Candidate Progress: The combination of mRNA-4157 and Merck's Keytruda has shown a significant reduction in disease recurrence or death in advanced melanoma patients, bolstering investor confidence in Moderna's cancer vaccine prospects, which could become a vital revenue source.
- Influenza Vaccine Submission: Moderna has submitted its mRNA-1010 influenza vaccine candidate for approval targeting adults aged 50 and older, expected to address the low efficacy issues in the flu vaccine market, particularly benefiting elderly patients.
- Declining Revenue Expectations: While Moderna anticipates revenue between $1.6 billion and $2 billion for 2025, the regulatory pressures in the coronavirus vaccine market may lead to declining sales, highlighting the challenges and opportunities the company faces during its transformation.
See More
FDA Declines to Review Approval for Moderna's New Flu Vaccine - WSJ
- FDA Refusal: The FDA has declined to consider the approval of Moderna's new flu vaccine.
- Impact on Public Health: This decision may affect the availability of new flu vaccination options for the upcoming flu season.
See More
MODERNA: U.S. FOOD AND DRUG ADMINISTRATION ISSUES REFUSAL-TO-FILE LETTER FOR MRNA-1010 SEASONAL INFLUENZA VACCINE CANDIDATE
Regulatory Update: Moderna has received a refusal letter from the U.S. Food and Drug Administration regarding its investigational seasonal influenza vaccine, mRNA-1010.
Vaccine Details: The vaccine is designed to target multiple strains of the influenza virus, but the FDA's decision indicates concerns that need to be addressed before moving forward.
See More
Investors Focus on Jobs Data and Earnings Reports
- Jobs Data Release: The Bureau of Labor Statistics is set to release the delayed January Non-Farm Payrolls report at 8:30 a.m. ET, which will provide crucial economic health indicators that could influence investor decisions and market trends.
- Nvidia Faces Competition: ByteDance is reportedly developing an AI chip and is in talks with Samsung Electronics for manufacturing, posing potential competitive pressure on Nvidia that could impact its market share and technological leadership.
- Retail Sentiment Shift: Retail sentiment towards the SPDR S&P 500 ETF remains 'bearish', while the Invesco QQQ Trust ETF sentiment has dropped from 'bearish' to 'extremely bearish', indicating heightened investor concerns over tech stocks that may affect their performance.
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See More
Moderna's Influenza Vaccine Application Rejected by FDA
- Application Rejection: Moderna's biologics license application for its influenza vaccine mRNA-1010 was not reviewed by the FDA, resulting in a nearly 9% drop in shares during after-hours trading.
- Priority Review Ineffective: Despite utilizing a priority review voucher to expedite the process, the FDA indicated that the clinical trial's control arm did not reflect the best available standard of care in the U.S. at the time, undermining the application’s validity.
- No Safety or Efficacy Concerns: The refusal letter did not identify any specific safety or efficacy issues regarding mRNA-1010, suggesting that the vaccine still holds potential in these areas.
- Future Plans Unaffected: Moderna stated that the refusal will not impact its 2026 financial guidance and has requested a meeting with FDA officials to clarify the next steps.
See More
Moderna's Flu Vaccine Application Rejected by FDA
- Regulatory Rejection: The FDA's refusal to file Moderna's flu vaccine application, citing a lack of a comparator reflecting the 'best-available standard of care' despite no safety or efficacy concerns, resulted in a nearly 9% drop in MRNA shares during after-hours trading.
- Clinical Trial Data: The biologics license application included two positive Phase 3 studies with 43,808 participants, one showing a stronger immune response in adults aged 65 and older and the other demonstrating higher effectiveness in adults aged 50 and older, yet the FDA did not accept the application.
- Seeking Further Clarity: CEO Stephane Bancel indicated that the company will request a Type A meeting with the FDA to clarify the rejection, highlighting inconsistencies with prior FDA guidance that had allowed the use of a licensed standard-dose vaccine as a comparator.
- Market Reaction and Outlook: Despite the FDA's decision adding regulatory uncertainty for vaccine manufacturers, Moderna plans to submit applications in other countries by 2026 and expects potential approvals outside the U.S. in late 2026 or early 2027, reflecting ongoing confidence in future market opportunities.
See More
Moderna's Stock Rises Due to Pipeline Progress
- Strong Stock Performance: Moderna's shares have surged 39% in 2026, despite the absence of recent financial results, indicating market confidence in its future potential ahead of the upcoming Q4 2025 earnings report.
- Pipeline Candidate Progress: The combination of mRNA-4157 and Merck's Keytruda has shown a significant reduction in disease recurrence or death in advanced melanoma patients, bolstering investor confidence in Moderna's cancer vaccine prospects, which could become a vital revenue source.
- Influenza Vaccine Submission: Moderna has submitted its mRNA-1010 influenza vaccine candidate for approval targeting adults aged 50 and older, expected to address the low efficacy issues in the flu vaccine market, particularly benefiting elderly patients.
- Declining Revenue Expectations: While Moderna anticipates revenue between $1.6 billion and $2 billion for 2025, the regulatory pressures in the coronavirus vaccine market may lead to declining sales, highlighting the challenges and opportunities the company faces during its transformation.
See More
FDA Declines to Review Approval for Moderna's New Flu Vaccine - WSJ
- FDA Refusal: The FDA has declined to consider the approval of Moderna's new flu vaccine.
- Impact on Public Health: This decision may affect the availability of new flu vaccination options for the upcoming flu season.
See More
MODERNA: U.S. FOOD AND DRUG ADMINISTRATION ISSUES REFUSAL-TO-FILE LETTER FOR MRNA-1010 SEASONAL INFLUENZA VACCINE CANDIDATE
Regulatory Update: Moderna has received a refusal letter from the U.S. Food and Drug Administration regarding its investigational seasonal influenza vaccine, mRNA-1010.
Vaccine Details: The vaccine is designed to target multiple strains of the influenza virus, but the FDA's decision indicates concerns that need to be addressed before moving forward.
See More
Investors Focus on Jobs Data and Earnings Reports
- Jobs Data Release: The Bureau of Labor Statistics is set to release the delayed January Non-Farm Payrolls report at 8:30 a.m. ET, which will provide crucial economic health indicators that could influence investor decisions and market trends.
- Nvidia Faces Competition: ByteDance is reportedly developing an AI chip and is in talks with Samsung Electronics for manufacturing, posing potential competitive pressure on Nvidia that could impact its market share and technological leadership.
- Retail Sentiment Shift: Retail sentiment towards the SPDR S&P 500 ETF remains 'bearish', while the Invesco QQQ Trust ETF sentiment has dropped from 'bearish' to 'extremely bearish', indicating heightened investor concerns over tech stocks that may affect their performance.
- Earnings Season Approaches: Investors are gearing up for quarterly earnings reports from companies like Shopify, Kraft Heinz, Unity Software, Cisco, QuantumScape, and MGM Resorts, which will provide critical insights into profitability outlooks and industry dynamics.
See More
Moderna's Influenza Vaccine Application Rejected by FDA
- Application Rejection: Moderna's biologics license application for its influenza vaccine mRNA-1010 was not reviewed by the FDA, resulting in a nearly 9% drop in shares during after-hours trading.
- Priority Review Ineffective: Despite utilizing a priority review voucher to expedite the process, the FDA indicated that the clinical trial's control arm did not reflect the best available standard of care in the U.S. at the time, undermining the application’s validity.
- No Safety or Efficacy Concerns: The refusal letter did not identify any specific safety or efficacy issues regarding mRNA-1010, suggesting that the vaccine still holds potential in these areas.
- Future Plans Unaffected: Moderna stated that the refusal will not impact its 2026 financial guidance and has requested a meeting with FDA officials to clarify the next steps.
See More
Moderna's Flu Vaccine Application Rejected by FDA
- Regulatory Rejection: The FDA's refusal to file Moderna's flu vaccine application, citing a lack of a comparator reflecting the 'best-available standard of care' despite no safety or efficacy concerns, resulted in a nearly 9% drop in MRNA shares during after-hours trading.
- Clinical Trial Data: The biologics license application included two positive Phase 3 studies with 43,808 participants, one showing a stronger immune response in adults aged 65 and older and the other demonstrating higher effectiveness in adults aged 50 and older, yet the FDA did not accept the application.
- Seeking Further Clarity: CEO Stephane Bancel indicated that the company will request a Type A meeting with the FDA to clarify the rejection, highlighting inconsistencies with prior FDA guidance that had allowed the use of a licensed standard-dose vaccine as a comparator.
- Market Reaction and Outlook: Despite the FDA's decision adding regulatory uncertainty for vaccine manufacturers, Moderna plans to submit applications in other countries by 2026 and expects potential approvals outside the U.S. in late 2026 or early 2027, reflecting ongoing confidence in future market opportunities.
See More
