Moderna Inc (NASDAQ:MRNA, ETR:0QF) shares edged higher after the US Food and Drug Administration (FDA) approved its newest COVID-19 vaccine mNEXSPIKE (mRNA-1283). The vaccine was approved for use in adults aged 65 and older and individuals aged 12 to 64 who have at least one underlying health risk factor as defined by the Centers for Disease Control and Prevention (CDC), Moderna said on Monday.
Moderna said mNEXSPIKE was approved by the FDA for use in adults aged 65 and up, as well as some individuals aged 12 to 64.
The U.S. Food and Drug Administration has approved Moderna's next-generation COVID-19 vaccine for all individuals aged 65 and above, the company said on Saturday, the first endorsement since the regulator tightened requirements.
Moderna, Inc. (NASDAQ:MRNA ) Bernstein 41st Annual Strategic Decisions Conference Call May 29, 2025 10:00 AM ET Company Participants Stephane Bancel - CEO & Director Conference Call Participants Courtney Breen - Bernstein Courtney Breen So I am thrilled to be here today with Stephane Bancel from Moderna. My name is Courtney Breen.
The government scraps funding deal for MRNA's bird flu shot, despite encouraging safety and efficacy data from early clinical studies on the vaccine.
The Trump administration has cancelled a contract awarded to Moderna for the late-stage development of its bird flu vaccine for humans, as well as the right to purchase shots, according to the drugmaker.
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 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.
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.