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 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.
Moderna (NASDAQ:MRNA) announced a strategic collaboration with Recordati to advance investigational propionic acidemia therapeutic mRNA-3927 through final clinical development and, upon approval, global commercialization. Moderna will lead development and manufacturing; Recordati will lead commercialization. Financial terms include $50M upfront and up to $110M in near-term milestones, plus commercial milestones and tiered royalties. The agreement is subject to customary closing conditions, including U.S. antitrust clearance expected within 30 days. A pivotal data readout is expected in 2026.
Moderna (NASDAQ:MRNA) will report fourth quarter 2025 financial results on Friday, February 13, 2026 with a live conference call and webcast at 8:00 a.m. ET. The company will also provide a corporate update during the call.
A live webcast will be available under Events and Presentations in the Investors section of Moderna's website. The archived webcast will be posted about two hours after the call and will remain available for one year.
Moderna (NASDAQ:MRNA) and Merck (NYSE:MRK) reported median five-year follow-up data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study showing that intismeran autogene plus KEYTRUDA reduced the risk of recurrence or death by 49% (HR=0.510; 95% CI 0.294-0.887; one-sided nominal p=0.0075) versus KEYTRUDA alone in patients with resected high-risk stage III/IV melanoma.
The safety profile remained consistent with prior reports. Moderna and Merck plan further follow-up presentations and continue enrollment across eight Phase 2/3 studies, with the Phase 3 adjuvant melanoma trial fully enrolled.
Moderna (NASDAQ:MRNA) provided business and pipeline updates at the 44th J.P. Morgan Healthcare Conference on January 12, 2026. The company expects 2025 revenue ≈ $1.9B (unaudited), improved GAAP operating expense outlook to $5.0–$5.2B, and year-end cash ≈ $8.1B. Moderna reiterated a target of up to 10% revenue growth in 2026, expects GAAP operating expenses of ~$4.9B in 2026, and aims for cash breakeven by 2028. Key 2026 catalysts include potential approvals for seasonal flu and flu/COVID vaccines and multiple pivotal data readouts across oncology, rare disease, and infectious disease.