MRNA Stock Recent News

Moderna files with FDA for updated Spikevax aimed at the LP.8.1 variant, which makes up 70% of U.S. COVID-19 cases.

Moderna (NASDAQ: MRNA) has caught the market off guard with a significant recovery in recent days – reaching current levels of approximately $27 after hitting a five-year low of $23.15 last week – following the FDA's decision to continue advising annual COVID-19 vaccinations for high-risk populations. However, this abrupt rally appears to be a singular occurrence – competitors such as Pfizer (NYSE: PFE), Sarepta Therapeutics (NASDAQ: SRPT), and CureVac (NASDAQ:CVAC) did not replicate Moderna's increase – implying the rise was primarily fueled by the FDA guidance rather than a wider sector uptrend.

Moderna said on Friday it had filed a marketing application for an updated COVID vaccine to the U.S. Food and Drug Administration.

CAMBRIDGE, MA / ACCESS Newswire / May 23, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2025-2026 formula, targeting the SARS-CoV-2 variant LP.8.1. The submission is based on guidance from the U.S. FDA, which advised that COVID-19 vaccines should be updated to a monovalent JN.1 lineage, with a preference for the LP.8.1 variant.

Moderna's voluntary withdrawal of the filing stems from the FDA's request for vaccine efficacy data from a phase III study on the experimental flu shot.

Moderna Inc. NASDAQ: MRNA is down 35% in 2025, making it one of the worst-performing stocks among medical stocks and the broader market. Not surprisingly, the stock is down over 80% in the last 12 months.

Though the new FDA rules limit access to COVID-19 booster vaccines, the commitment to high-risk groups lifts Moderna, Pfizer and BioNTech stocks.

Moderna said on Wednesday it had withdrawn the pending application for its flu and COVID combination vaccine candidate for adults aged 50 years and older.

CAMBRIDGE, MA / ACCESS Newswire / May 21, 2025 / Moderna, Inc. (Nasdaq:MRNA), today announced that in consultation with the U.S. Food and Drug Administration (FDA), the Company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older. The Company plans to resubmit the BLA later this year, after vaccine efficacy data from the ongoing Phase 3 trial of its investigational seasonal influenza vaccine, mRNA-1010, are available.

Moderna Inc (NASDAQ:MRNA, ETR:0QF) shares jumped more than 6.5% on Tuesday after the US Food and Drug Administration unveiled a new framework for COVID-19 vaccine approvals that analysts said largely maintains the status quo for the company's core market. The FDA's updated guidance does not change how COVID-19 vaccines are authorized for individuals aged 65 and older or those aged six months to 64 years who are at high risk.