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) 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.
Moderna (NASDAQ:MRNA) has announced its participation in two major healthcare investor conferences in September 2025. The company will present at the Morgan Stanley's 23rd Annual Global Healthcare Conference on September 8th at 10:00am ET and at Bernstein Insights: Healthcare Leaders and Disruptors on September 25th at 10:30am ET.
Investors can access live webcasts of both presentations through the "Events and Presentations" section of Moderna's investor website. The webcasts will remain archived on the company's website for a minimum of 30 days after each presentation.
Harbinger Health announced the appointment of Ajit Singh, Ph.D. as its new CEO and CEO-Partner of Flagship Pioneering. Singh, who has served on Harbinger's board since 2024, brings extensive diagnostics industry experience, particularly from his tenure at Siemens and leadership in oncology diagnostics companies.
Current CEO Stephen Hahn, M.D. will transition to CEO Emeritus and Special Advisor while maintaining his position on the Board of Directors. The leadership change comes as Harbinger advances its platform for early cancer detection using blood-based tests that analyze proprietary methylation patterns of cell-free ctDNA.
The company recently presented data showing promising results in detecting multiple high-incidence, high-mortality cancers related to obesity, along with platform innovations to enhance cancer signal detection.
Moderna (NASDAQ:MRNA) reported Q2 2025 financial results with revenues of $142 million, down 41% year-over-year, and a GAAP net loss of $(0.8) billion or $(2.13) per share. The company reduced its 2025 revenue guidance to $1.5-$2.2 billion, a $300 million reduction at the high end due to delivery timing shifts. Cost optimization efforts led to improved operating expense outlook, reduced by $400 million.
Key developments include three recent FDA approvals for COVID-19 vaccines and positive Phase 3 efficacy results for seasonal influenza vaccine. The company maintains a strong cash position of $7.5 billion and projects year-end cash balance of approximately $6 billion. Moderna also announced a workforce reduction of approximately 10%, targeting under 5,000 employees by year-end.