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 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.
Moderna (NASDAQ:MRNA) was named a top employer in the global biopharmaceutical industry by Science and Science Careers in the 2025 Top Employers Survey for the eleventh consecutive year. The recognition cites Moderna's focus on innovation, employee-centered culture and investments in advanced manufacturing hubs in Australia, Canada and the United Kingdom. In 2025 Moderna received approval for its third product, mNEXSPIKE, a COVID-19 vaccine for adults 65+ and ages 12–64 with specified risk factors.
The survey was based on ~5,500 completed responses, primarily from North America, Europe and Asia/Pacific Rim.
Moderna (Nasdaq: MRNA) will host an Investor Event - Analyst Day at 9:00 a.m. ET on Thursday, November 20, 2025.
Management will present on Moderna's development and commercial strategy and key business considerations. A live webcast will be available at investors.modernatx.com under Events and Presentations. A replay will be archived on Moderna's website for at least 30 days following the presentation.
Moderna (NASDAQ: MRNA) announced that its Phase 3 pivotal trial of investigational CMV vaccine mRNA-1647 did not meet the primary efficacy endpoint in seronegative women aged 16–40, and the company will discontinue its congenital CMV development program.
The randomized, observer-blind, placebo-controlled trial enrolled ~7,500 women across ~300 sites in 13 countries. Vaccine efficacy against primary CMV infection ranged from 6% to 23% depending on case definition. mRNA-1647 was generally well tolerated and no safety concerns were reported by the Data and Safety Monitoring Board. Moderna will continue a Phase 2 study of mRNA-1647 in bone marrow transplant patients and does not expect any impact to its 2025 financial guidance or its expectation of achieving breakeven in 2028.
Moderna (NASDAQ:MRNA) announced presentations of clinical data for two influenza vaccine candidates at IDWeek 2025 (Oct 19-22, 2025) in Atlanta.
mRNA-1010: Late-breaking data in adults ≥50 showed relative vaccine efficacy (rVE) versus a licensed standard-dose influenza vaccine of 26.6% (95% CI: 16.7%, 35.4%), meeting prespecified superiority; rVE against medically-attended/severe influenza was 33.7% (95% CI: 12.0, 50.0%). The candidate was described as well-tolerated; most common solicited adverse reactions were injection site pain, fatigue, headache, and myalgia.
mRNA-1018: Phase 1/2 dose-ranging data in adults ≥18 showed rapid, persistent immune responses with 97.8% of participants meeting seroprotective levels three weeks after the second dose (95% CI: 95.4, 99.2); 79.5% reached protective levels three weeks after the first dose and 70.6% maintained seroprotective titers six months after dose two (95% CI: 64.8, 76.0).
Moderna (NASDAQ:MRNA) will report third quarter 2025 financial results on Thursday, November 6, 2025 with a live conference call and webcast at 8:00 a.m. ET.
The live webcast will be available under "Events and Presentations" in the Investors section of Moderna's website at https://investors.modernatx.com. An archived webcast will be posted about two hours after the call and will remain available for one year.
Moderna (NASDAQ:MRNA) will present early clinical, safety and translational data for investigational cancer antigen therapy mRNA-4359 at ESMO 2025 (Oct 17-21).
In a Phase 1/2 study of 29 checkpoint inhibitor‑resistant/refractory melanoma patients treated with mRNA-4359 plus pembrolizumab (400 µg, n=14; 1,000 µg, n=15), the objective response rate (ORR) was 24% and the disease control rate (DCR) was 60%. In PD-L1+ tumors (TPS≥1%, 9 evaluable), ORR was 67% (6 of 9). Median duration of response was not reached. The therapy advanced into the Phase 2 portion and showed a consistently manageable safety profile with no new immune-related adverse events. Presentation details and an investor webcast on Oct 17, 2025, are announced.
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.