Moderna stock surged more than 6% on Wednesday after the US Food and Drug Administration reversed its earlier decision and agreed to review the company’s mRNA flu vaccine. The regulatory agency had initially rejected Moderna’s application just last week, citing concerns about the drugmaker’s clinical trials. The FDA’s change of course marks a significant development for Moderna’s efforts to expand its mRNA technology beyond COVID-19 vaccines into the seasonal influenza market.
According to a press release from Moderna, the FDA agreed to advance the application for review following what the company described as a constructive Type A meeting with regulators. To expedite the approval process, Moderna proposed a modified regulatory pathway based on age groups, seeking full approval for adults aged 50 to 64 and accelerated approval for those 65 and older.
Background on the FDA Rejection and Reversal
The FDA had issued a “refusal-to-file” letter on February 10, expressing dissatisfaction with Moderna’s clinical trial data for the mRNA flu vaccine. That initial rejection caused shares to fall approximately 2% at the time. The vaccine was developed using the same mRNA technology that forms the foundation of Moderna’s successful COVID-19 vaccine.
However, the swift reversal suggests that negotiations between Moderna and the FDA yielded a mutually acceptable path forward. CEO Stéphane Bancel had previously criticized what he called “uncertainty” in the US regulatory environment during the company’s fourth-quarter earnings call, stating it “creates real challenges for businesses, patients and the broader innovation ecosystem.”
Implications for Moderna’s Market Position
The FDA’s decision to review the flu vaccine represents a critical milestone for Moderna as it works to diversify its product portfolio beyond COVID-19 vaccines. In his statement, Bancel expressed appreciation for the FDA’s engagement and indicated that pending approval, the company hopes to make the flu vaccine available later this year. Additionally, he emphasized that approval would provide America’s seniors with a new option for influenza protection.
Meanwhile, the positive news comes amid a remarkable rally for Moderna stock in 2026. Shares have climbed more than 55% since the beginning of the year, significantly outperforming pharmaceutical competitors including Pfizer, BioNTech, and AstraZeneca, according to market data.
Recent Performance and Pipeline Developments
Moderna’s stock performance has been supported by better-than-expected financial results and promising developments in its research pipeline. In February, the company reported an adjusted loss of $2.11 per share on revenue of $678 million, beating analyst estimates of a $2.64 loss per share and $623.9 million in revenue.
Furthermore, shares experienced a roughly 15% surge on January 21 after Moderna announced positive clinical trial results for an experimental skin cancer vaccine developed in partnership with Merck. The company also revealed in February a five-year strategic agreement with the government of Mexico to supply respiratory vaccines throughout the country.
Regulatory Pathway and Timeline
The age-based regulatory strategy proposed by Moderna could potentially accelerate the approval timeline for certain patient populations. Accelerated approval for adults 65 and older would be particularly significant, as this demographic faces higher risks from seasonal influenza and represents a substantial market opportunity.
The timeline for final FDA approval of the mRNA flu vaccine remains uncertain, though Moderna has indicated it hopes to bring the vaccine to market later this year pending regulatory clearance. The company has not specified an exact target date for when it expects the FDA review process to conclude or when commercial distribution might begin.
