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 cutting-edge biotech company based in Cambridge, Massachusetts, founded in 2010. Moderna is at the forefront of pioneering messenger RNA therapeutics™, a revolutionary class of drugs that utilize mRNA technology to direct cells to produce proteins that can fight diseases. This innovative approach has shown promise in addressing targets that were previously considered untreatable with traditional drugs.
With over 200 patent applications and more than 10,000 claims, Moderna has a robust intellectual property portfolio that includes novel nucleotide chemistries and specific drug compositions. The company has successfully developed and commercialized several mRNA-based drugs, initially focusing on rare diseases and oncology, while partnering to advance drug candidates in other therapeutic areas.
Moderna’s mRNA technology gained global recognition with its COVID-19 vaccine, Spikevax®, which was one of the earliest vaccines to receive emergency use authorization in the United States in December 2020. As of mid-2023, Moderna had 39 mRNA development candidates in clinical trials, covering a wide range of therapeutic areas such as infectious diseases, oncology, cardiovascular diseases, and rare genetic disorders.
Some of Moderna's recent achievements include the advancement of three new vaccine programs—targeting Epstein-Barr virus, Varicella-Zoster virus, and norovirus—towards Phase 3 clinical trials. Additionally, the company initiated three new clinical studies combining its investigational individualized neoantigen therapy with Merck’s Keytruda® for treating various cancers.
Financially, Moderna reported first-quarter revenues of $167 million in 2024, with a GAAP net loss of $1.2 billion. Despite the decline in COVID-19 vaccine sales, the company reaffirms its 2024 expected product sales of approximately $4 billion. Moderna is preparing for the launches of its RSV vaccine and the Spikevax® 2024-2025 formula, demonstrating its commitment to fighting respiratory illnesses.
Moderna continues to focus on innovation and operational efficiency, utilizing AI technologies to enhance productivity. The company's long-term vision includes leveraging its mRNA platform to develop therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, and autoimmune diseases, striving to make a significant impact on global health.
Moderna has initiated a Phase 2/3 clinical trial for its RSV vaccine candidate, mRNA-1345, with plans to enroll approximately 34,000 participants across multiple countries.
RSV is responsible for significant health issues in older adults and young children but currently lacks an approved vaccine. The Company reports an estimated $3 billion annual medical cost due to RSV in the U.S., with about 177,000 hospitalizations and 14,000 deaths among adults 65 and older annually. The trial aims to evaluate the safety and efficacy of mRNA-1345 in adults over 60, supporting future licensure efforts.
Moderna Inc. (Nasdaq: MRNA) has submitted a request for authorization to Health Canada for a 50 µg two-dose series of its COVID-19 vaccine, SPIKEVAX, aimed at children aged 6 to 11. The ongoing Phase 2/3 ‘KidCOVE’ study reports a vaccine efficacy of 100% against symptomatic COVID-19 and 80% for any SARS-CoV-2 infection post-first dose. The firm plans to share these findings with global regulatory bodies to ensure broader protection for this vulnerable age group.
Moderna has received authorization from Health Canada for a booster dose of its COVID-19 vaccine, SPIKEVAX, at a 50 µg dose for individuals aged 18 and older, to be given at least six months after the primary series.
The decision was based on clinical data indicating significant increases in neutralizing antibody levels post-booster, including in adults over 65. The safety profile aligns with previous doses, establishing confidence in the vaccine's continued efficacy against variants.
Moderna announced positive results from the Phase 2 EPICCURE study assessing AZD8601, an mRNA therapeutic for patients undergoing coronary artery bypass grafting (CABG). The study met its primary endpoint of safety and tolerability with 11 participants, revealing numerical improvements in heart failure endpoints, including increased left ventricular ejection fraction (LVEF). All treated patients maintained healthy NT-proBNP levels at follow-up. This data reinforces the potential of AZD8601 for advancing treatment options in heart failure and warrants further exploration in larger studies.
Moderna (MRNA) announced interim data from a Phase 1 study of mRNA-2752 for treating solid tumors and lymphomas, demonstrating tolerability at all doses tested. The combination therapy with durvalumab (IMFINZI®) showed encouraging anti-tumor activity, with a recommended dose for expansion set at 8mg. Presenting at the Society for Immunotherapy of Cancer's Annual Meeting, the study indicated immunomodulation effects, including increased T cell activation. Ongoing trials continue for various cancers, showcasing the potential of Moderna’s innovative mRNA platform in oncology.
Moderna (Nasdaq: MRNA) has submitted a variation for conditional marketing authorization of its COVID-19 vaccine (mRNA-1273) for children aged 6 to 11 years to the European Medicines Agency (EMA). This marks Moderna's first submission for this age group. The ongoing Phase 2/3 KidCOVE study has shown vaccine efficacy of 100% for symptomatic COVID-19 and 80% for all SARS-CoV-2 infections after the first dose. The company plans to share data with various regulatory agencies globally to protect younger populations.
Moderna reported a robust Q3 2021 with total revenue of $5.0 billion, a significant increase from $157 million in Q3 2020. The net income surged to $3.3 billion, resulting in diluted EPS of $7.70. Key developments include the U.S. FDA granting Priority Review for the COVID-19 vaccine BLA and promising interim efficacy results from the KidCOVE study showing 100% effectiveness after the first dose in kids aged 6-12. Moderna also initiated a Phase 3 study for a CMV vaccine and unveiled plans for inhaled pulmonary therapeutics with Vertex.
Moderna (NASDAQ:MRNA) announces a strategic collaboration with Metagenomi focused on in vivo gene editing therapeutics. The multi-year partnership, covering undisclosed disease targets, includes an upfront cash payment, equity investment, and research funding, with potential milestone and royalty payments. The collaboration aims to leverage Metagenomi's advanced gene editing systems and Moderna's mRNA and LNP technologies to develop transformative therapies for genetic diseases. This partnership strengthens Moderna's portfolio in genomic medicine.
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