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. (NASDAQ: MRNA) is a biotechnology company focused on mRNA medicines, with multiple approved vaccines and a broad clinical pipeline. The MRNA news page on Stock Titan aggregates company announcements, investor updates and regulatory developments so readers can follow how Moderna’s strategy and pipeline progress translate into real-world events.
Investors and observers can use this feed to track commercial updates on products such as Spikevax, mRESVIA and mNEXSPIKE, along with developments in late-stage respiratory programs like the seasonal influenza vaccine mRNA-1010, the flu/COVID combination vaccine mRNA-1083 and the Norovirus vaccine candidate mRNA-1403. News items often cover regulatory submissions and opinions from agencies including the U.S. Food and Drug Administration, the European Medicines Agency, Health Canada and others.
The page also surfaces pipeline and clinical trial news in oncology and rare diseases, including updates on mRNA-4157 (intismeran autogene), mRNA-4359, mRNA-3927 for propionic acidemia and mRNA-3705 for methylmalonic acidemia. Announcements related to partnerships, such as CEPI’s funding commitment for the H5 pandemic influenza vaccine candidate mRNA-1018, appear here as well.
In addition, the MRNA news feed includes financial results, guidance and capital structure updates, such as quarterly earnings releases, multi-year financial frameworks and information on facilities like the $1.5 billion credit agreement. Corporate items, including participation in healthcare conferences, Analyst Day presentations and shareholder meeting outcomes, are also reflected.
By reviewing this consolidated news stream, readers can see how Moderna’s respiratory vaccine franchise, oncology and rare disease programs, manufacturing expansion and financing decisions evolve over time, all based on the company’s own disclosures and related announcements.
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 ~<$2.2B> 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.
Moderna (NASDAQ:MRNA) filed for marketing authorization of its investigational seasonal influenza vaccine mRNA-1010 with the FDA, EMA, Health Canada and the TGA in Australia for adults aged 50 and older on January 5, 2026.
Regulatory applications rely on positive Phase 3 data: in study P304 mRNA-1010 met a prespecified superiority criterion with a relative vaccine efficacy (rVE) of 26.6% (95% CI 16.7%–35.4%) across adults ≥50 and an rVE of 27.4% in participants ≥65. Prior study P303 showed superior seroconversion rates and GMRs versus high-dose and standard-dose licensed vaccines. Safety was described as favorable, with most solicited adverse reactions reported as mild.
Moderna (NASDAQ:MRNA) and CEPI announced up to $54.3 million in funding to support a pivotal Phase 3 trial of Moderna's investigational mRNA H5 pandemic influenza vaccine candidate, mRNA-1018. The Phase 3 study is planned to begin early 2026 in the UK and U.S. and follows positive Phase 1/2 immune-response data.
If licensed, Moderna will allocate 20% of H5 manufacturing capacity for timely supply to low- and middle-income countries at affordable pricing.
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