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) 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.
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.