Moderna (MRNA) shares rose more than 6% on Wednesday after the U.S. Food and Drug Administration agreed to review the drugmaker’s first flu vaccine of the season, reversing a decision last week to deny review.
Moderna recently developed a new flu vaccine using the same mRNA technology as its COVID-19 vaccine. But after requesting a federal review, the FDA initially declined to review the drug — a necessary regulatory step to bring the drug to market — saying it was not satisfied with Moderna’s trial.
On February 10, after Moderna issued a “refusal to submit” letter from the FDA, the company’s stock price fell by approximately 2%. During the company’s fourth-quarter earnings call, CEO Stéphane Bancel said the current “uncertainty” of the U.S. regulatory regime “poses real challenges for businesses, patients and the broader innovation ecosystem.”
However, on Wednesday morning, Moderna announced in a press release that the FDA had changed course and agreed to review the drug.
The drugmaker said that in an effort to expedite approval, it proposed “an age-based regulatory pathway that would seek full approval for adults ages 50 to 64 years and accelerated approval for adults 65 years and older.”
“We are grateful to the FDA for engaging in a constructive Class A meeting and agreeing to move forward with our review application,” Bancel said in a statement. “While awaiting FDA approval, we look forward to launching our flu vaccine later this year so that older Americans have access to a new option to protect themselves from the flu.”
Those gains set Moderna up for a strong start to 2026, with the company’s shares up more than 55% since the start of the year, even as pharmaceutical rivals such as Pfizer, BioNTech and AstraZeneca have seen much smaller gains.
In early February, Moderna reported a smaller-than-expected adjusted earnings per share (EPS) loss, sending shares higher. The drugmaker reported an adjusted loss of $2.11 per share on revenue of $678 million, compared with analysts’ estimates of losses of $2.64 per share and $623.9 million.
Meanwhile, Moderna’s results were boosted by positive progress in its drug development pipeline.
On January 21, the company’s shares surged about 15% after it announced positive clinical results for an experimental skin cancer vaccine developed in partnership with Merck ( MRK ). The company also announced a five-year strategic agreement with the Mexican government in February to supply respiratory vaccines in the country.