Moderna Stock Price, News & Analysis

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.

Moderna (NASDAQ:MRNA) has submitted an FDA application for its updated Spikevax 2025-2026 formula, specifically designed to target the SARS-CoV-2 LP.8.1 variant. The submission aligns with FDA guidance recommending COVID-19 vaccines be updated to a monovalent JN.1 lineage, with preference for the LP.8.1 variant.

Moderna (NASDAQ:MRNA) has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, its combination flu/COVID vaccine candidate for adults aged 50 and older. The withdrawal comes after consultation with the FDA. The company plans to resubmit the BLA later in 2025 after obtaining vaccine efficacy data from the ongoing Phase 3 trial of mRNA-1010, its investigational seasonal influenza vaccine. Interim data from the mRNA-1010 trial is expected to be available in summer 2025.