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) 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.
Moderna (Nasdaq: MRNA) will present at the 44th annual J.P. Morgan Healthcare Conference on Monday, January 12 at 7:30 p.m. ET / 4:30 p.m. PT. A live webcast will be available under "Events and Presentations" in the Investors section at investors.modernatx.com. A replay will be archived on Moderna's website for at least 30 days following the presentation.
Moderna (NASDAQ:MRNA) said the EMA's CHMP adopted a positive opinion recommending marketing authorization of mNEXSPIKE (mRNA-1283) for prevention of COVID-19 in individuals aged 12 years and older. The recommendation follows a Phase 3 trial of ~11,400 participants that reported a 9.3% higher relative vaccine efficacy versus mRNA-1273 and a 13.5% higher rVE in adults aged 65+. Safety was similar to mRNA-1273 with fewer local reactions. The European Commission will decide on authorization; if approved, Moderna expects to make mNEXSPIKE available in EU markets pending regulatory timelines and local access pathways. Moderna noted prior approvals from the U.S. FDA and Health Canada.
Moderna (NASDAQ:MRNA) outlined a three-year strategy on November 20, 2025, targeting up to 10% revenue growth in 2026 and a path to cash breakeven in 2028. The company plans to expand its seasonal vaccine franchise from three to as many as six approved products by 2028 and expects readouts from nine ongoing Phase 2 and Phase 3 oncology studies, including three Phase 3 programs for intismeran.
Moderna lowered expected cash costs to about $4.2B in 2026 and $3.5–$3.9B in 2027, projects a >10 percentage-point gross margin improvement over three years, and closed a $1.5B five-year term loan, updating year-end cash to $7.1–$7.6B.
Moderna (NASDAQ:MRNA) closed a five-year non-dilutive term loan facility for up to $1.5 billion with Ares Management Credit Funds on November 20, 2025.
The facility includes a $600 million initial term loan funded at closing, a $400 million delayed-draw term loan available through November 2027, and an additional $500 million delayed-draw tranche available through November 2028 that is contingent on achievement of key regulatory milestones aligned with Moderna's late-stage clinical pipeline.
Moderna reiterated its 2025 financial guidance and reaffirmed a target to reach cash breakeven by 2028. The company also scheduled an Analyst Day webcast for November 20, 2025 at 9:00 a.m. ET.
Moderna (NASDAQ:MRNA) is expanding U.S. manufacturing by onshoring Drug Product capabilities to its Moderna Technology Center in Norwood, Massachusetts. The project includes a >$140 million investment and is expected to create hundreds of biomanufacturing jobs, enabling full end-to-end mRNA manufacturing in the U.S. for commercial and clinical supply. Construction has started and Moderna is targeting completion by the first half of 2027. The move reinforces Moderna's domestic manufacturing footprint and supports its pipeline of mRNA vaccines and therapeutics across infectious diseases, cancer, rare diseases, and autoimmune disorders.
Moderna (Nasdaq: MRNA) will present at Piper Sandler's 37th Annual Healthcare Conference on Tuesday, December 2, 2025 at 11:00 AM ET. A live webcast of the presentation will be available under Events and Presentations in the Investors section at investors.modernatx.com. A replay will be archived on Moderna's website for at least 30 days following the presentation.
Moderna (NASDAQ:MRNA) reported Q3 2025 revenue of $1.0B, a GAAP net loss of $200M and GAAP EPS of $(0.51). The company narrowed 2025 revenue guidance to $1.6–$2.0B, improved expected GAAP operating expenses by $0.7B to $5.2–$5.4B, and raised year-end cash projections to $6.5–$7.0B. Cash and investments were $6.6B as of September 30, 2025.
Commercially, Q3 COVID vaccine sales were $971M (U.S. $781M, international $190M); mNEXSPIKE received FDA approval for older adults and certain adults with risk factors and is approved in 40 countries. RSV vaccine mRESVIA generated $2M in Q3 and is approved in 40 countries for 60+ adults. Clinical updates include discontinuation of congenital CMV after a Phase 3 miss, norovirus Phase 3 accrual delays, and multiple late‑stage oncology and rare‑disease milestones on track.
Moderna (NASDAQ:MRNA) announced on November 3, 2025 that the first patient has been dosed in a Phase 1/2 dose‑escalation study of mRNA‑2808, an investigational mRNA‑based T‑cell engager (TCE) for relapsed or refractory multiple myeloma (RRMM).
mRNA‑2808 encodes three TCEs that target three validated myeloma‑associated antigens to address tumor heterogeneity and potential target‑mediated resistance. The first dose was given at SCRI Oncology Partners in Nashville in collaboration with Sarah Cannon Research Institute. The study (NCT07116616) will evaluate safety and tolerability in adults aged 18 and older.