Moderna Stock Price, News & Analysis

Moderna (NASDAQ:MRNA) announced the acceptance of three abstracts for presentation at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin from October 17-21, 2025. The presentations include a mini oral presentation on mRNA-4359 focusing on clinical outcomes in melanoma treatment, and two poster presentations on intismeran autogene (V940/mRNA-4157), which is being jointly developed with Merck.

The presentations will cover studies involving checkpoint inhibitor-resistant melanoma treatment, non-muscle-invasive bladder cancer therapy, and first-line therapy for advanced melanoma. Moderna will also host an analyst event during the congress, with details to be announced later.

Moderna (NASDAQ:MRNA) has received a positive opinion from the European Medicines Agency's CHMP recommending marketing authorization for its updated COVID-19 vaccine Spikevax®. The new formulation targets the SARS-CoV-2 variant LP.8.1 and is intended for the 2025-2026 vaccination season.

The vaccine is designed for individuals six months of age and older. The CHMP's decision is based on manufacturing and preclinical data, along with previous clinical, non-clinical, and real-world evidence. The updated vaccine composition aligns with global health authorities' guidance, which identified LP.8.1 as an appropriate strain for the upcoming vaccination season.

Flagship Pioneering has unveiled Terrana Biosciences, a new agricultural technology company developing RNA-based solutions for crop enhancement and protection. The company emerges with an initial $50 million commitment from Flagship Pioneering after four years of platform development.

Terrana's proprietary RNA technology platform enables the development of targeted products that can work throughout a plant's lifecycle, creating solutions that adapt to variable climate conditions. The company has already demonstrated proof of concept in tomatoes, corn, and soy, and generated a pipeline of over 15 potential products in specialty and row crops.

The company's platform leverages AI and computational models to assemble a vast RNA library and design system for creating novel functional crop traits. Their solutions aim to help farmers combat diseases and pests, adapt to climate conditions, and maintain soil health, while offering advantages over conventional approaches in terms of timing flexibility and environmental impact.

Moderna (NASDAQ:MRNA) has announced positive Phase 3 results for its seasonal influenza vaccine candidate mRNA-1010. The vaccine demonstrated 26.6% superior relative vaccine efficacy (95% CI; 16.7%, 35.4%) compared to a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older.

The study showed strong relative vaccine efficacy across all influenza strains: 29.6% for A/H1N1, 22.2% for A/H3N2, and 29.1% for B/Victoria lineages. In participants aged 65 and older, mRNA-1010 achieved a 27.4% relative vaccine efficacy. The Phase 3 trial (P304) enrolled 40,805 adults across 11 countries, with a median follow-up of six months.

Safety and tolerability profiles were consistent with previous studies, with most solicited adverse reactions being mild. The most common local reaction was injection site pain, while fatigue, headache, and myalgia were the most common systemic reactions. Moderna plans to present the data at an upcoming medical conference and engage with regulators for submissions.

Moderna (NASDAQ:MRNA) has received FDA approval for mRESVIA (mRNA-1345), its RSV vaccine, for adults aged 18-59 who are at increased risk for RSV disease. This expands the previous approval from May 2024 for adults 60 and older. The approval is based on Phase 3 study results showing comparable immune responses to those in older adults. Over one-third of adults aged 18-59 have underlying conditions putting them at increased risk of severe RSV disease. The vaccine demonstrated consistent immunogenicity across age subgroups and was generally well-tolerated, with common side effects including injection site pain, fatigue, headache, myalgia, and arthralgia. Moderna plans to make mRESVIA available for both age groups during the 2025-2026 respiratory virus season.

Moderna (NASDAQ: MRNA) has announced its upcoming participation in the Barclays Speaking the Science Call Series, scheduled for Monday, June 16th, 2025, at 10:00 AM ET. Investors and interested parties can access the live webcast of the presentation through the 'Events and Presentations' section on Moderna's investor relations website at investors.modernatx.com. The presentation recording will remain available on the company's website for a minimum of 30 days after the event.

Moderna (NASDAQ:MRNA) has received FDA approval for mNEXSPIKE (mRNA-1283), its third approved product and new COVID-19 vaccine for adults 65+ and high-risk individuals aged 12-64. The approval is based on a Phase 3 trial with 11,400 participants, where mNEXSPIKE demonstrated 9.3% higher relative vaccine efficacy compared to Moderna's original Spikevax vaccine, with a 13.5% improvement in those 65 and older. The vaccine showed a similar safety profile to Spikevax with fewer local reactions. Common side effects include injection site pain, fatigue, headache, and myalgia. Moderna plans to make mNEXSPIKE available for the 2025-2026 respiratory virus season alongside Spikevax and mRESVIA.

Moderna (NASDAQ:MRNA) announced positive interim results from a Phase 1/2 clinical study of its investigational pandemic influenza vaccine, mRNA-1018, targeting H5 avian influenza. The study involving 300 healthy adults showed that 97.8% of participants achieved protective antibody levels with a 44.5-fold increase in titers from baseline. The vaccine demonstrated a rapid, potent, and durable immune response with good tolerability. However, Moderna also revealed that the U.S. Department of Health and Human Services (HHS) will terminate funding for the late-stage development and purchase rights of pre-pandemic influenza vaccines. Despite this setback, CEO Stéphane Bancel emphasized the positive clinical data and announced plans to explore alternative paths for the program's development.

Moderna (NASDAQ: MRNA) has announced its upcoming participation in two major investor conferences in June 2025. The company will present at the Jefferies Global Health Care Conference on June 5th at 10:30am ET and the Goldman Sachs 46th Annual Global Healthcare Conference on June 11th at 8:40am ET.

Live webcasts of both presentations will be accessible through the "Events and Presentations" section on Moderna's investor website. Replays will remain available for at least 30 days after each presentation.