Moderna's Flu Candidate Approved for FDA Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5 days ago
0mins
Should l Buy MRNA?
Source: NASDAQ.COM
- Regulatory Review Shift: After initially refusing to review Moderna's flu vaccine candidate, the FDA reversed its decision following Moderna's proposal for a revised regulatory approach, paving the way for a potential launch ahead of the upcoming flu season.
- Sales Growth Expectations: Moderna anticipates that seasonal vaccine sales will drive cash breakeven by 2028, and the company has reiterated its forecast for up to 10% revenue growth in 2023, indicating strong potential in the vaccine market.
- Pipeline Advancements: Moderna is advancing multiple candidates in its pipeline, including a promising oncology vaccine, and despite facing regulatory challenges, the diversity of its pipeline supports long-term growth prospects.
- Market Performance Volatility: Moderna's stock saw significant gains during the early pandemic but experienced fluctuations due to declining vaccine sales; however, optimism about a turnaround led to a 50% stock price increase in January.
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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: 53.570
Low
17.00
Averages
32.47
High
63.00
Current: 53.570
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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- Clinical Trial Data: The recommendation is based on data from 8,000 individuals aged 50 and older, demonstrating that antibody levels against flu and SARS-CoV-2 were non-inferior to those receiving the COVID vaccine Spikevax and flu vaccines Fluzone HD or Fluarix, indicating its efficacy.
- Market Potential: Targeting individuals aged 50 and older, mCombriax addresses the dual protection needs of the elderly, which is expected to drive further growth for Moderna in the vaccine market.
- Regulatory Dynamics: Although Moderna withdrew its application with the US FDA in May 2025, the EMA's recommendation may pave the way for future global market promotion of the vaccine.
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Focus on Accessibility: The company aims to enhance the distribution and accessibility of its vaccine to a broader population.
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