Moderna's Flu Vaccine Application Accepted by FDA for Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
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Should l Buy MRNA?
Source: Newsfilter
Moderna's stock rose 5% as it reached a 5-day high, following the FDA's acceptance of its flu vaccine application for review.
The FDA's decision to review Moderna's experimental mRNA flu vaccine marks a significant turnaround from an earlier rejection, which has generated optimism among investors about the company's prospects in the flu vaccine market. This acceptance is particularly crucial as Moderna seeks full approval for adults aged 50 to 64 and accelerated approval for those aged 65 and older, indicating a strategic focus on the older demographic. The positive market reaction reflects investor confidence in Moderna's future potential, especially with the upcoming flu season.
This development could lead to substantial revenue growth for Moderna if the vaccine is approved, although the company has faced challenges in achieving profitability since 2022. Investors are encouraged to monitor the progress of the FDA review and the company's ongoing commitment to vaccine safety.
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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: 46.600
Low
17.00
Averages
32.47
High
63.00
Current: 46.600
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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See More
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- 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
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