The recommendation from regulators paves the way for the shot's approval in the European Union at a time the company is facing scrutiny in the U.S.
Moderna (MRNA) – a developer of mRNA-focused therapeutics and vaccines – has recorded a 6-day winning streak, accumulating gains of 25% during this time. The company's market capitalization has increased by approximately $4.0 billion over the past 6 days and now sits at $20 billion.
MRNA stock rises 6% as the FDA agrees to review its flu vaccine filing after a surprise reversal, with a decision expected by Aug. 5, 2026.
Moderna Inc (NASDAQ:MRNA, XETRA:0QF) announced that the US Food and Drug Administration (FDA) will initiate review of its investigational seasonal influenza vaccine, mRNA-1010, following a Type A meeting between the company and the agency. Shares of Moderna added 6.5% at about $47 on the update.
The FDA's “refuse-to-file” letter sent to reject Moderna's application is a rarity: A 2021 study found that 4% of the nearly 2,500 applications submitted to the agency receive such letters, many of which cited drug efficacy, safety and quality.
Moderna's stock was surging after the FDA said it would review the biotech's flu-vaccine candidate, a week after it had refused to do so.
Pharma giant Moderna Inc (NASDAQ:MRNA) is enjoying a boost today, after the U.S. Food & Drug Administration (FDA) accepted the company's flu vaccine application for review.
The Food and Drug Administration has reversed its decision not to review a new flu vaccine from Moderna, the pharmaceutical company said Wednesday.
The company's mRNA flu shot, if approved, could be available for the 2026-27 flu season.
Moderna said on Wednesday the U.S. Food and Drug Administration has accepted its application to review its influenza vaccine candidate.
MRNA shares jumped 5.3% as investors rotated into large-cap biotech, betting on its expanding pipeline in volatile trade.
Moderna, Inc. (MRNA) Q4 2025 Earnings Call Transcript