Moderna Gains Over 6% as FDA Agrees to Review mRNA Flu Vaccine
Moderna stock jumped over 6% after the FDA reversed its refusal-to-file decision and agreed to review the company's first seasonal mRNA flu vaccine. Moderna has proposed full approval for ages 50–64 and accelerated approval for adults 65+, and its shares have risen over 55% year-to-date.
1. FDA Reverses Decision and Stock Reaction
Moderna initially faced a refusal-to-file letter from the FDA after submitting its first seasonal mRNA flu vaccine, citing unsatisfactory trial data. Following a Type A meeting, the agency agreed to advance the application, triggering a more than 6% share price increase.
2. Proposed Regulatory Pathway
To expedite market entry, Moderna proposed a dual-path approval: full approval for adults aged 50 to 64 and accelerated approval for those 65 and older. This strategy aims to deliver the vaccine to seniors later in the year pending FDA sign-off.
3. Year-to-Date Performance and Pipeline Highlights
Moderna shares have soared over 55% since January, bolstered by a smaller-than-expected Q4 adjusted loss of $2.11 per share on $678 million revenue and positive clinical results of its experimental skin cancer vaccine. The company also finalized a five-year respiratory vaccine supply agreement with Mexico’s government.