Moderna (MRNA) stock jumped more than 6% on Wednesday after the US Food and Drug Administration agreed to review the drugmaker’s first flu shot of the season, reversing course on a decision to reject the review last week.
Moderna recently developed a new flu vaccine using the same mRNA technique that underpins its COVID-19 vaccine. But after requesting review from the federal government, the FDA initially declined to review the drug — a necessary regulatory step toward bringing the drug to market — saying that it wasn’t satisfied with Moderna’s trials.
Shares fell roughly 2% on Feb. 10 after the Moderna published the FDA’s “refusal-to-file” letter. On the company’s fourth-quarter earnings call, CEO Stéphane Bancel said current “uncertainty” in the US regulatory regime “creates real challenges for businesses, patients and the broader innovation ecosystem.”
On Wednesday morning, however, Moderna announced in a press release that the FDA had reversed course and agreed to review the drug.
The drugmaker said that, to expedite approval, it had proposed a “regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older.”
“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Bancel said in the statement. “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.”
The gains add to a soaring start to 2026 for Moderna, whose shares are up more than 55% since the start of the year even as pharmaceutical competitors like Pfizer, BioNTech, and AstraZeneca have seen much smaller gains.
Shares rallied earlier in February when Moderna reported a smaller-than-expected loss in adjusted earnings per share (EPS). The drugmaker reported an adjusted loss of $2.11 per share and revenue of $678 million against analysts estimates of a loss of $2.64 per share and $623.9 million.
At the same time, Moderna’s performance has been bolstered by positive developments in its drug development pipeline.
Shares surged by roughly 15% on Jan. 21 after the company announced positive clinical results on an experimental skin cancer vaccine developed in partnership with Merck (MRK). The company also announced in February a five-year strategic agreement with the government of Mexico to supply respiratory vaccines in the country.
