Moderna

MRNA

Market cap $20.9B

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.

mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive a positive CHMP opinion recommending marketing authorization and represents Moderna's fourth vaccine to receive a positive CHMP opinion mCOMBRIAX will be made available in the European Union, subject to final European Commission authorization and national regulatory and access procedures CAMBRIDGE, MASSACHUSETTS / ACCESS Newswire / February 27, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization in the European Union for mCOMBRIAX® (mRNA-1083), Moderna's combination vaccine indicated for active immunization for the prevention of influenza and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older. "The CHMP's positive opinion represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world's first flu plus COVID combination vaccine.

Europe's medicines regulator on Friday recommended granting marketing authorisation to mCombriax, making Moderna's messenger RNA vaccine the world's first combined shot for people aged 50 and older against COVID and seasonal influenza in a single dose.

Moderna has faced good and bad times in recent years. Most recently, the FDA refused to review Moderna's flu candidate -- then reversed course.

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.

U.S. Food and Drug Administration Commissioner Marty Makary on Monday defended his agency's position and record on mRNA vaccines, days after it changed course and agreed to review a Moderna flu vaccine.

Moderna helped to rapidly create vaccines for COVID-19, leading to a financial windfall. But those vaccine sales have waned, and so has the company's top line.

Philippe Laffont bought shares of CoreWeave in the first quarter of last year and recently closed that position. The investor favors tech stocks and innovators.

Biopharmaceutical company BioNTech sued Moderna in Delaware federal court on Thursday, alleging that Moderna's COVID-19 vaccine mNexspike infringes a patent related to BioNTech and Pfizer's competing shot Comirnaty.

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.