Moderna Shares Soar 6% After FDA Agrees to Review Age-Based Flu Shot
Moderna shares jumped over 6% after the FDA reversed its refusal-to-file decision and agreed to review the company’s mRNA-based seasonal flu vaccine application. The drugmaker has proposed full approval for adults 50–64 and accelerated approval for those 65 and older, aiming to launch the shot later this year.
1. FDA Reverses Refusal-to-File Decision
After initially declining to review Moderna’s first mRNA-based seasonal flu vaccine application due to unsatisfactory trial data, the FDA has agreed to advance the filing following a constructive Type A meeting. This reversal clears a necessary regulatory hurdle toward potential market authorization.
2. Proposed Age-Based Regulatory Pathway
Moderna proposed a two-tiered approval strategy: full approval for adults aged 50 to 64 and accelerated approval for adults 65 and older. This approach is designed to expedite availability for high-risk seniors pending successful review.
3. Market Reaction and Stock Performance
Moderna shares surged more than 6% on the FDA decision, adding to a 55% year-to-date gain. The rally follows a smaller-than-expected Q4 adjusted loss of $2.11 per share on $678 million in revenue, beating estimates of a $2.64 loss and $623.9 million.
4. Broader Pipeline and Growth Implications
Positive clinical results on an experimental skin cancer vaccine with Merck and a five-year respiratory vaccine supply deal with Mexico have bolstered investor confidence. The flu vaccine review is the latest milestone in Moderna’s effort to diversify beyond COVID-19 products.