Welcome to our dedicated page for Moderna news (Ticker: MRNA), a resource for investors and traders seeking the latest updates and insights on Moderna stock.
Moderna, Inc. reports developments in mRNA medicines, including commercial vaccines, investigational respiratory vaccines, oncology programs and rare-disease candidates. News commonly covers regulatory authorizations and agency interactions for products such as Spikevax, mRESVIA, mNEXSPIKE and mCOMBRIAX, as well as clinical data for seasonal influenza, pandemic influenza and cancer immunotherapy programs including intismeran autogene and mRNA-4359.
Company updates also include quarterly financial results, revenue mix, expense actions, strategic partnerships, scientific meeting presentations and intellectual-property matters tied to Moderna's infectious disease portfolio and broader mRNA technology platform.
Moderna (NASDAQ:MRNA) announced presentations of clinical data for two influenza vaccine candidates at IDWeek 2025 (Oct 19-22, 2025) in Atlanta.
mRNA-1010: Late-breaking data in adults ≥50 showed relative vaccine efficacy (rVE) versus a licensed standard-dose influenza vaccine of 26.6% (95% CI: 16.7%, 35.4%), meeting prespecified superiority; rVE against medically-attended/severe influenza was 33.7% (95% CI: 12.0, 50.0%). The candidate was described as well-tolerated; most common solicited adverse reactions were injection site pain, fatigue, headache, and myalgia.
mRNA-1018: Phase 1/2 dose-ranging data in adults ≥18 showed rapid, persistent immune responses with 97.8% of participants meeting seroprotective levels three weeks after the second dose (95% CI: 95.4, 99.2); 79.5% reached protective levels three weeks after the first dose and 70.6% maintained seroprotective titers six months after dose two (95% CI: 64.8, 76.0).
Moderna (NASDAQ:MRNA) will report third quarter 2025 financial results on Thursday, November 6, 2025 with a live conference call and webcast at 8:00 a.m. ET.
The live webcast will be available under "Events and Presentations" in the Investors section of Moderna's website at https://investors.modernatx.com. An archived webcast will be posted about two hours after the call and will remain available for one year.
Moderna (NASDAQ:MRNA) will present early clinical, safety and translational data for investigational cancer antigen therapy mRNA-4359 at ESMO 2025 (Oct 17-21).
In a Phase 1/2 study of 29 checkpoint inhibitor‑resistant/refractory melanoma patients treated with mRNA-4359 plus pembrolizumab (400 µg, n=14; 1,000 µg, n=15), the objective response rate (ORR) was 24% and the disease control rate (DCR) was 60%. In PD-L1+ tumors (TPS≥1%, 9 evaluable), ORR was 67% (6 of 9). Median duration of response was not reached. The therapy advanced into the Phase 2 portion and showed a consistently manageable safety profile with no new immune-related adverse events. Presentation details and an investor webcast on Oct 17, 2025, are announced.
Moderna (NASDAQ:MRNA) has officially opened its Moderna Innovation and Technology Centre (MITC) in Harwell, Oxfordshire, UK. The state-of-the-art facility will manufacture mRNA vaccines for the UK population and conduct research in various therapeutic areas.
The facility, which can produce up to 100 million mRNA vaccine doses annually (expandable to 250 million during pandemics), represents a key milestone in Moderna's ten-year strategic partnership with the UK Government. The MITC is the first facility in the UK to manufacture mRNA vaccines onshore and includes Clinical R&D laboratories for analyzing global trial samples.
Under the partnership, Moderna has already conducted over 20 clinical trials across 110 UK sites, becoming the country's largest commercial trial sponsor. The MITC joins Moderna's global manufacturing network, which includes facilities in Australia and Canada.
Moderna (NASDAQ:MRNA) has announced positive preliminary immunogenicity data for its 2025-2026 formula of mNEXSPIKE COVID-19 vaccine. The Phase 4 clinical trial demonstrated that the vaccine generated a greater than 16-fold increase in neutralizing antibodies against the LP.8.1 variant in high-risk individuals aged 12-64 and adults 65+.
The company's other COVID-19 vaccine, Spikevax, showed an 8-fold increase in LP.8.1-neutralizing antibodies across the same age groups. The safety profile remained consistent with previous studies, supporting the FDA's recent approval of the 2025-2026 mNEXSPIKE formula for high-risk individuals and older adults.
Moderna (NASDAQ:MRNA) has achieved a significant milestone with the delivery of its first made-in-Canada mRNA vaccines to provinces and territories. The company's Spikevax® COVID-19 vaccine, targeting the SARS-CoV-2 LP.8.1 variant, is now fully manufactured in Canada with drug substance production in Laval, Quebec, and fill-and-finish operations in Cambridge, Ontario.
The vaccine, which received Health Canada approval on August 21, 2025, will be available through public vaccination programs, with timing and eligibility determined by individual provinces and territories. The company is also working with private insurers to ensure access for those not covered under public programs.
This development represents a major advancement in Canada's domestic vaccine production capacity and demonstrates the successful collaboration between government, industry, and scientific sectors.
Moderna (NASDAQ:MRNA) has announced positive preliminary immunogenicity data for its 2025-2026 formula of Spikevax®, targeting the LP.8.1 COVID-19 variant. The Phase 4 clinical trial demonstrated an 8-fold increase in neutralizing antibodies against LP.8.1 in high-risk individuals aged 12-64 and all adults over 65.
The vaccine has received FDA approval for individuals 6 months through 64 years with high-risk conditions and all adults 65+. The safety profile remains consistent with previous studies, with no new concerns identified. The vaccine has also secured approvals in multiple international markets including Canada, Europe, Japan, Mexico, and Switzerland.
Moderna (NASDAQ:MRNA) announced the acceptance of five abstracts for presentation at the 2025 International Congress of Inborn Errors of Metabolism (ICIEM) in Kyoto, Japan. The presentations include three oral and two poster presentations covering the company's research on propionic acidemia (PA), methylmalonic acidemia (MMA), and Glycogen Storage Disease Type 1a (GSD1a) programs.
The presentations will feature interim data from Phase 1/2 studies of mRNA-3705 for MMA and mRNA-3745 for GSD1a, marking Moderna's first presentations at a scientific congress for these conditions. Additionally, final results from the mRNA-3927 dose-escalation study for PA treatment will be presented, along with clinical burden data and model-informed dose selection analyses.
Moderna (NASDAQ:MRNA) has received FDA approval for its updated COVID-19 vaccines, Spikevax® and mNEXSPIKE®, targeting the LP.8.1 variant of SARS-CoV-2 for the 2025-2026 season. Spikevax is approved for high-risk individuals aged 6 months to 64 years and all adults over 65, while mNEXSPIKE is approved for high-risk individuals aged 12 to 64 years and all adults over 65.
The vaccines, developed following FDA guidance for monovalent JN.1 lineage targeting, are expected to be available immediately. The approval comes as COVID-19 caused 4 million outpatient visits and nearly 500,000 hospitalizations last year. The vaccines have already received regulatory approval in Canada, Europe, Japan, and Switzerland.
Moderna (NASDAQ:MRNA) has received Health Canada's approval for its updated COVID-19 vaccine Spikevax®, targeting the SARS-CoV-2 LP.8.1 variant. The vaccine is authorized for individuals aged six months and older.
In a significant milestone for Canadian biomanufacturing, all 2025 pre-filled syringe doses will be manufactured domestically. The drug substance will be produced at Moderna's new Laval, Quebec facility, with fill-finish operations at Novocol Pharma in Cambridge, Ontario. The vaccine has already received approvals in Europe, Japan, and Switzerland, with additional regulatory reviews ongoing globally.