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) will present late-breaking revaccination data for its investigational seasonal influenza vaccine mRNA-1010 and its RSV vaccine mRESVIA (mRNA-1345) at ESCMID 2026 in Munich on April 18, 2026.
Results show similar day-29 HAI geometric mean fold rises across three WHO influenza strains after sequential mRNA-1010 dosing, numerically higher versus an egg-based comparator, and no new safety signals. Interim mRESVIA data in adults 60+ showed well-tolerated heterologous revaccination and potential restoration of protection. mRNA-1010 is under regulatory review in the US, Europe, Canada and Australia with potential first approvals in 2026.
Moderna (NASDAQ:MRNA) reached a global settlement with Arbutus and Genevant resolving litigation tied to Spikevax and related mRNA assets. Moderna will pay a $950 million lump sum in Q3 2026 and may pay up to an additional $1.3 billion depending on a Federal Circuit ruling.
The company will record a $950 million charge in Q1 2026, expects no accrual for contingent payment, and forecasts year-end 2026 cash of $4.5–$5.0 billion with total liquidity of $5.4–$5.9 billion.
Moderna (NASDAQ:MRNA) announced the EMA CHMP adopted a positive opinion recommending EU marketing authorization for mCOMBRIAX (mRNA-1083), a first-in-class influenza plus COVID-19 combination vaccine for adults 50 years and older. The opinion is supported by a pivotal Phase 3 trial and an acceptable safety profile.
Final authorization depends on a European Commission decision and national regulatory/access processes; if approved, this would be Moderna's fourth marketed product in Europe.
Moderna (Nasdaq:MRNA) will present at two investor conferences in March 2026. Presentations are scheduled for TD Cowen 46th Annual Healthcare Conference on March 3, 2026 at 1:50 PM ET and Barclays 28th Annual Global Healthcare Conference on March 10, 2026 at 9:30 AM ET.
A live webcast will be available under Events and Presentations in the Investors section at investors.modernatx.com, with replays archived for at least 30 days after each presentation.
Moderna (NASDAQ:MRNA) announced the FDA has accepted its biologics license application for seasonal influenza vaccine candidate mRNA-1010 and set a PDUFA goal date of August 5, 2026.
The company proposed a regulatory pathway seeking full approval for adults 50–64 and accelerated approval for adults 65+, with a post‑marketing study in older adults. Moderna says mRNA-1010 is also accepted for review in Europe, Canada, and Australia, and expects potential first approvals in 2026 pending regulatory reviews.
Moderna (NASDAQ:MRNA) announced the European Commission granted marketing authorization for mNEXSPIKE (mRNA-1283) for active immunization against COVID-19 in individuals aged 12 and older.
The authorization covers all 27 EU member states plus Iceland, Liechtenstein and Norway. A Phase 3 trial (~11,400 participants) showed mNEXSPIKE had 9.3% higher relative efficacy versus Spikevax and 13.5% higher in adults 65+. Safety was similar with fewer local reactions. Moderna expects to make mNEXSPIKE available in Europe pending regulatory timelines and local access pathways.
Moderna (NASDAQ: MRNA) reported Q4 2025 revenue $678M and GAAP net loss $826M, with full-year 2025 revenue of $1.9B and GAAP net loss of $2.8B. Cash and investments were $8.1B at year-end.
The company cut ~ in annual operating expenses, reiterated a plan for up to 10% revenue growth in 2026, and provided pipeline updates including EU/Canada/Australia flu filings, an FDA Refusal-to-File with a requested Type A meeting, a fully enrolled norovirus Phase 3 trial, and multiple oncology and rare-disease milestones expected in 2026.
Moderna (NASDAQ:MRNA) said the FDA's CBER issued a Refusal-to-File (RTF) for its BLA for investigational influenza vaccine mRNA-1010, citing the choice of a licensed standard-dose comparator as the sole reason and not identifying safety or efficacy concerns.
Moderna requested a Type A meeting to clarify the path forward and notes mRNA-1010 is under review in the EU, Canada and Australia; the company does not expect an impact to its 2026 financial guidance.
Moderna (NASDAQ:MRNA) signed a five-year Memorandum of Understanding with the Government of Mexico, BIRMEX, and Laboratorios Liomont to support Plan Mexico, enable access to Moderna's respiratory vaccine portfolio, and transfer technology to Liomont to produce mRNA-1273 domestically.
The agreement includes collaboration on local clinical R&D, pandemic preparedness, and follows COFEPRIS approval of Moderna's 2025-2026 COVID-19 vaccine for ages 6 months and older plus a government purchase adjudication for up to 10 million doses.
Moderna (NASDAQ:MRNA) named David Berman, M.D., Ph.D., as Chief Development Officer effective March 2, 2026. He will join the Executive Committee and report to CEO Stéphane Bancel. Dr. Jacqueline Miller will step down as Chief Medical Officer and remain as a consultant to help the transition.
Berman brings two decades of development experience in immunotherapy and oncology, including leadership roles at Immunocore, AstraZeneca and Bristol-Myers Squibb, and led approvals including a first T cell receptor therapeutic. The company notes a pipeline with three approved vaccines and three programs in Phase 3 or filed for approval.