Moderna Stock Price, News & Analysis

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.

Moderna (NASDAQ:MRNA) has achieved a significant milestone with the delivery of its first made-in-Canada mRNA vaccines to provinces and territories. The company's Spikevax® COVID-19 vaccine, targeting the SARS-CoV-2 LP.8.1 variant, is now fully manufactured in Canada with drug substance production in Laval, Quebec, and fill-and-finish operations in Cambridge, Ontario.

The vaccine, which received Health Canada approval on August 21, 2025, will be available through public vaccination programs, with timing and eligibility determined by individual provinces and territories. The company is also working with private insurers to ensure access for those not covered under public programs.

This development represents a major advancement in Canada's domestic vaccine production capacity and demonstrates the successful collaboration between government, industry, and scientific sectors.

Moderna (NASDAQ:MRNA) has announced positive preliminary immunogenicity data for its 2025-2026 formula of Spikevax®, targeting the LP.8.1 COVID-19 variant. The Phase 4 clinical trial demonstrated an 8-fold increase in neutralizing antibodies against LP.8.1 in high-risk individuals aged 12-64 and all adults over 65.

The vaccine has received FDA approval for individuals 6 months through 64 years with high-risk conditions and all adults 65+. The safety profile remains consistent with previous studies, with no new concerns identified. The vaccine has also secured approvals in multiple international markets including Canada, Europe, Japan, Mexico, and Switzerland.