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 study of its Omicron-specific bivalent booster candidate (mRNA-1273.214), which combines mRNA-1273.529 and the original COVID-19 vaccine, mRNA-1273. The trial aims to enroll approximately 375 participants across 20 sites in the U.S. and will assess the immunogenicity, safety, and reactogenicity of the booster in adults. The study marks an extension of prior research and aligns with Moderna's commitment to adapt vaccines for emerging variants. Results will be shared with public health authorities ahead of the upcoming booster season.
Moderna, Inc. (NASDAQ:MRNA) will host its virtual Vaccines Day for analysts and investors on March 24, 2022, at 8:00 a.m. ET. The event will feature management presentations and insights from key opinion leaders regarding Moderna's mRNA vaccines and important developmental considerations. A live webcast will be accessible in the Investors section of the Moderna website, with a replay available for one year thereafter. Moderna has evolved to become a leading mRNA therapeutics and vaccines company, contributing significantly to pandemic efforts with its COVID-19 vaccine.
Moderna has unveiled a new global public health strategy through four key initiatives aimed at advancing mRNA vaccines for infectious diseases. The company plans to develop vaccines targeting 15 priority pathogens by 2025. Additionally, mRNA Access will allow researchers worldwide to utilize Moderna's mRNA technology. The company has also expanded its patent pledge, ensuring no enforcement in 92 low- and middle-income countries. Notably, Moderna will establish its first mRNA manufacturing facility in Kenya, investing up to $500 million to produce up to 500 million doses annually.
Moderna is investing up to $500 million to establish its first mRNA manufacturing facility in Kenya, aiming to produce up to 500 million doses of vaccines annually for the African continent. This initiative, made in partnership with the U.S. Government, focuses on enhancing local manufacturing capabilities to ensure equitable access to vaccines. The facility will initially handle drug substance manufacturing and may expand to include fill/finish services. Moderna's commitment is a significant step towards improving global health equity and preparing for future health crises.
Moderna (NASDAQ:MRNA) announced plans to create an Enterprise Solutions Hub in Atlanta, Georgia, supporting the U.S., Canada, and Latin America. The hub aims to hire 150-200 employees over two years, focusing on finance, human resources, procurement, and digital functions. CEO Stéphane Bancel highlighted the need for business services aligned with skilled talent. The Atlanta hub complements an existing hub in Warsaw, Poland. Moderna anticipates expanding its commercial subsidiaries globally, emphasizing the strategic choice of Atlanta for its diverse and skilled workforce.
Moderna, Inc. (NASDAQ:MRNA) announced its schedule for three upcoming investor conferences in March 2022. The events include the Cowen 42nd Annual Health Care Conference on March 9 at 9:10 a.m. ET, the Barclays Global Healthcare Conference on March 15 at 1:30 p.m. ET, and the Oppenheimer 32nd Annual Healthcare Conference on March 17 at 10:00 a.m. ET. Live webcasts will be available on Moderna's investor website, with replays accessible for 30 days post-event. Moderna continues to lead in mRNA therapeutics and has received recognition for its contributions to COVID-19 vaccine development.
Moderna has received a positive opinion from the EMA's CHMP to expand the conditional marketing authorization for its COVID-19 vaccine, Spikevax, to include children aged 6-11. This follows a successful Phase 2/3 study involving over 4,000 children, demonstrating non-inferior antibody responses compared to 18-25 year-olds. The European Commission will decide on the authorization. Additionally, the EMA updated the recommendation for booster doses, now allowing a booster after three months instead of six, and heterologous booster combinations.
Moderna reported remarkable Q4 2021 revenues of $7.2 billion, with a net income of $4.9 billion and diluted EPS of $11.29. For the full year, revenue reached $18.5 billion, significantly up from $803 million in 2020, driven mainly by COVID-19 vaccine sales. The company secured $19 billion in advance purchase agreements for 2022 and announced a $3 billion share repurchase plan. Moderna also received FDA approval for its Spikevax vaccine and is progressing with 44 programs in its mRNA pipeline.
Moderna and Thermo Fisher Scientific have entered a 15-year strategic collaboration agreement for large-scale manufacturing of mRNA vaccines, including Spikevax®, in the U.S. This partnership aims to enhance manufacturing capacity and efficiency for Moderna's investigational mRNA medicines. Thermo Fisher will provide dedicated aseptic fill-finish services, packaging, and inspection to support Moderna's ongoing development efforts. The collaboration builds on their existing relationship that has successfully supported Moderna's COVID-19 vaccine production.
Moderna, Inc. (NASDAQ:MRNA) has signed a distribution agreement with Adium Pharma S.A., enhancing its COVID-19 vaccine access across 18 Latin American countries, including Brazil and Mexico. This accords with Moderna's strategy to expand its commercial presence in 2022, targeting ten additional markets, notably in Asia-Pacific and Europe. Moderna's COVID-19 vaccine has been approved in over 70 markets, with 807 million doses shipped globally in 2021. Through GAVI, it aims to supply 650 million doses to 92 low- and middle-income countries.