Moderna's Flu Vaccine Receives FDA Review Approval
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 hours ago
0mins
Should l Buy MRNA?
Source: CNBC
- FDA Review Decision: The FDA's agreement to review Moderna's experimental mRNA flu vaccine reverses its earlier refusal, stunning Wall Street and the medical community, marking a significant advancement in vaccine development.
- Positive Market Reaction: Following the FDA review announcement, Moderna's shares rose over 6%, reflecting investor confidence in the company's future flu vaccine market potential and paving the way for its goal of breaking even by 2028.
- New Application Strategy: Moderna's revised regulatory approach seeks full approval for adults aged 50 to 64 and accelerated approval for those 65 and older, addressing FDA criticisms of its trial design and enhancing the vaccine's market competitiveness.
- Changing Regulatory Environment: The FDA's decision highlights significant shifts in U.S. vaccine regulatory policies, particularly under the leadership of the new Secretary of Health and Human Services, with Moderna's application process facing stricter scrutiny, illustrating the complexities and challenges of vaccine regulation.
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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: 43.930
Low
17.00
Averages
32.47
High
63.00
Current: 43.930
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.
MODERNA STOCK RISES 6.6% FOLLOWING FDA'S START OF REVIEW FOR COMPANY'S INFLUENZA VACCINE
Moderna's Share Performance: Moderna's shares have increased by 6.6% following a review by the FDA.
FDA Review Focus: The FDA's review pertains to the influenza vaccine developed by Moderna.
See More
Moderna Shares Surge Following FDA's Start of Flu Vaccine Review
- FDA Review Announcement: The U.S. Food and Drug Administration (FDA) will begin reviewing Moderna's investigational seasonal flu vaccine.
- Company Statement: Moderna announced the initiation of the review on Wednesday.
See More
Moderna's mRNA-1010 Marketing Application Accepted by FDA
- FDA Acceptance: The U.S. FDA has accepted Moderna's marketing application for mRNA-1010, marking a significant advancement in the company's vaccine development, with a target action date set for August 5, 2026, thereby laying the groundwork for future market expansion.
- Revised Application Pathway: During a Type A meeting with the FDA, Moderna proposed an amended biologics license application (BLA) that includes an age-dependent regulatory pathway and a post-marketing requirement for additional trials in older adults, demonstrating the company's commitment to regulatory compliance.
- Market Expectations: Moderna plans to launch mRNA-1010 for adults aged 50 and older in the 2026/2027 flu season, a strategy that not only addresses the demand for flu vaccines among the elderly but also has the potential to enhance the company's market share and brand influence.
- Stock Price Recovery: Following the FDA's acceptance of the application, Moderna's shares gained in premarket trading, reflecting investor optimism about the company's future growth potential, especially after facing pressure from last week's FDA refusal-to-file letter.
See More
Moderna's COVID-19 Vaccine mNEXSPIKE Receives EU Marketing Authorization
- EU Marketing Authorization: Moderna's COVID-19 vaccine mNEXSPIKE has received marketing authorization from the European Commission for individuals aged 12 and older, marking the company's third product approved in the EU, thereby enhancing its competitive position in the global vaccine market.
- Clinical Trial Results: In a randomized, controlled Phase 3 trial involving approximately 11,400 participants, mNEXSPIKE demonstrated a 9.3% higher relative vaccine efficacy compared to Spikevax, with a 13.5% increase in adults aged 65 and older, providing strong support for its market launch.
- Safety Profile: The safety profile of mNEXSPIKE is comparable to Spikevax, with fewer local reactions and similar systemic reactions, and the most commonly reported adverse effects include injection site pain, fatigue, headache, and myalgia, indicating good tolerability.
- Market Outlook: Moderna has already secured regulatory approval for mNEXSPIKE in the U.S., Canada, and Australia, and is pursuing additional market authorizations worldwide, which is expected to drive future revenue growth for the company.
See More
Moderna's Seasonal Flu Vaccine Application Accepted by FDA
- Vaccine Application Progress: Moderna's application for a new seasonal flu vaccine has been accepted by the FDA, which, while not guaranteeing approval, has led to a 5.5% increase in Moderna's stock on Wednesday, reflecting market optimism about potential future revenues.
- Safety Testing Commitment: After the FDA previously rejected the application, Moderna has committed to conducting additional safety tests to ensure the vaccine's safety for elderly patients, a move that seems to satisfy the FDA's requirements and may expedite the vaccine's market launch.
- Significant Market Opportunity: The global flu vaccine market is projected to generate $9.2 billion annually, and if Moderna's vaccine is approved, it could lead to substantial revenue growth for the company, although the FDA commissioner has indicated that applications will not be rubber-stamped.
- Uncertain Profit Outlook: Despite the stock surge, Moderna has not turned a profit since 2022, reporting losses of $2.8 billion last year, and analysts predict it may not achieve profitability until 2029, leading to cautious investor sentiment regarding long-term stock holdings.
See More
Moderna's mRNA-1010 Application Advances to FDA Review
- FDA Review Progress: The FDA has notified Moderna that its biologics license application for mRNA-1010 will proceed to review, aiming to provide a vaccine for adults aged 50 and older during the 2026/2027 flu season, marking a significant expansion in the company's vaccine market presence.
- PDUFA Goal Date: The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2023, for mRNA-1010, indicating the regulatory body's focus on the product, which could drive revenue growth for Moderna in the future.
- Financial Performance Exceeds Expectations: Moderna reported a fourth-quarter loss of $2.11, beating the expected loss of $2.59, while quarterly sales reached $678 million, surpassing the anticipated $626 million, demonstrating strong performance in the vaccine market.
- Stock Technical Analysis: Currently, Moderna's stock is trading 6.6% above its 20-day simple moving average and 49.6% above its 100-day moving average, indicating strong long-term market performance, although the RSI and MACD indicators suggest mixed momentum in the market.
See More
MODERNA STOCK RISES 6.6% FOLLOWING FDA'S START OF REVIEW FOR COMPANY'S INFLUENZA VACCINE
Moderna's Share Performance: Moderna's shares have increased by 6.6% following a review by the FDA.
FDA Review Focus: The FDA's review pertains to the influenza vaccine developed by Moderna.
See More
Moderna Shares Surge Following FDA's Start of Flu Vaccine Review
- FDA Review Announcement: The U.S. Food and Drug Administration (FDA) will begin reviewing Moderna's investigational seasonal flu vaccine.
- Company Statement: Moderna announced the initiation of the review on Wednesday.
See More
Moderna's mRNA-1010 Marketing Application Accepted by FDA
- FDA Acceptance: The U.S. FDA has accepted Moderna's marketing application for mRNA-1010, marking a significant advancement in the company's vaccine development, with a target action date set for August 5, 2026, thereby laying the groundwork for future market expansion.
- Revised Application Pathway: During a Type A meeting with the FDA, Moderna proposed an amended biologics license application (BLA) that includes an age-dependent regulatory pathway and a post-marketing requirement for additional trials in older adults, demonstrating the company's commitment to regulatory compliance.
- Market Expectations: Moderna plans to launch mRNA-1010 for adults aged 50 and older in the 2026/2027 flu season, a strategy that not only addresses the demand for flu vaccines among the elderly but also has the potential to enhance the company's market share and brand influence.
- Stock Price Recovery: Following the FDA's acceptance of the application, Moderna's shares gained in premarket trading, reflecting investor optimism about the company's future growth potential, especially after facing pressure from last week's FDA refusal-to-file letter.
See More
Moderna's COVID-19 Vaccine mNEXSPIKE Receives EU Marketing Authorization
- EU Marketing Authorization: Moderna's COVID-19 vaccine mNEXSPIKE has received marketing authorization from the European Commission for individuals aged 12 and older, marking the company's third product approved in the EU, thereby enhancing its competitive position in the global vaccine market.
- Clinical Trial Results: In a randomized, controlled Phase 3 trial involving approximately 11,400 participants, mNEXSPIKE demonstrated a 9.3% higher relative vaccine efficacy compared to Spikevax, with a 13.5% increase in adults aged 65 and older, providing strong support for its market launch.
- Safety Profile: The safety profile of mNEXSPIKE is comparable to Spikevax, with fewer local reactions and similar systemic reactions, and the most commonly reported adverse effects include injection site pain, fatigue, headache, and myalgia, indicating good tolerability.
- Market Outlook: Moderna has already secured regulatory approval for mNEXSPIKE in the U.S., Canada, and Australia, and is pursuing additional market authorizations worldwide, which is expected to drive future revenue growth for the company.
See More
Moderna's Seasonal Flu Vaccine Application Accepted by FDA
- Vaccine Application Progress: Moderna's application for a new seasonal flu vaccine has been accepted by the FDA, which, while not guaranteeing approval, has led to a 5.5% increase in Moderna's stock on Wednesday, reflecting market optimism about potential future revenues.
- Safety Testing Commitment: After the FDA previously rejected the application, Moderna has committed to conducting additional safety tests to ensure the vaccine's safety for elderly patients, a move that seems to satisfy the FDA's requirements and may expedite the vaccine's market launch.
- Significant Market Opportunity: The global flu vaccine market is projected to generate $9.2 billion annually, and if Moderna's vaccine is approved, it could lead to substantial revenue growth for the company, although the FDA commissioner has indicated that applications will not be rubber-stamped.
- Uncertain Profit Outlook: Despite the stock surge, Moderna has not turned a profit since 2022, reporting losses of $2.8 billion last year, and analysts predict it may not achieve profitability until 2029, leading to cautious investor sentiment regarding long-term stock holdings.
See More
Moderna's mRNA-1010 Application Advances to FDA Review
- FDA Review Progress: The FDA has notified Moderna that its biologics license application for mRNA-1010 will proceed to review, aiming to provide a vaccine for adults aged 50 and older during the 2026/2027 flu season, marking a significant expansion in the company's vaccine market presence.
- PDUFA Goal Date: The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2023, for mRNA-1010, indicating the regulatory body's focus on the product, which could drive revenue growth for Moderna in the future.
- Financial Performance Exceeds Expectations: Moderna reported a fourth-quarter loss of $2.11, beating the expected loss of $2.59, while quarterly sales reached $678 million, surpassing the anticipated $626 million, demonstrating strong performance in the vaccine market.
- Stock Technical Analysis: Currently, Moderna's stock is trading 6.6% above its 20-day simple moving average and 49.6% above its 100-day moving average, indicating strong long-term market performance, although the RSI and MACD indicators suggest mixed momentum in the market.
See More
