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, Inc. (Nasdaq: MRNA) has entered into a partnership with Tabuk Pharmaceutical Manufacturing Company, a subsidiary of Astra Industrial Group, to commercialize the Moderna COVID-19 Vaccine and future variant-specific boosters in Saudi Arabia. Tabuk will hold marketing authorization, allowing for the distribution of Moderna's COVID-19 vaccine and potential mRNA products. This collaboration aims to enhance vaccine accessibility in Saudi Arabia and aligns with the country's Vision 2030. Moderna's CEO expressed gratitude for the partnership, emphasizing the importance of collaboration in global vaccine distribution.
Moderna (Nasdaq: MRNA) announced it has requested emergency use authorization (EUA) from the FDA for its COVID-19 vaccine in adolescents. The Phase 2/3 TeenCOVE study demonstrated 100% efficacy in nearly 2,500 vaccinated adolescents, with no COVID-19 cases observed. The vaccine was generally well tolerated, matching the safety profile seen in adult trials. Ongoing monitoring will assess long-term safety. Moderna has also filed for authorizations with Health Canada and the European Medicines Agency, emphasizing its commitment to ending the COVID-19 pandemic.
Moderna (Nasdaq: MRNA) has partnered with Medison Pharma to commercialize its COVID-19 Vaccine across Central Eastern Europe and Israel. This collaboration spans 20 markets, covering over 175 million lives. Medison Pharma's expertise in innovative therapies aligns with Moderna's mRNA technology to enhance vaccine accessibility. Both companies are committed to combating the pandemic through effective delivery and distribution. Despite this positive development, potential risks associated with mRNA technology and regulatory approval remain, as stated in Moderna's forward-looking statements.
Moderna, Inc. (Nasdaq: MRNA) has submitted its COVID-19 vaccine for authorization in adolescents to Health Canada. Following encouraging results from the Phase 2/3 TeenCOVE study, which showed 100% efficacy in nearly 2,500 adolescents, the company plans to seek further approvals from the European Medicines Agency and the U.S. FDA. The vaccine exhibited a well-tolerated safety profile, with no significant concerns identified. Moderna currently holds various emergency authorizations globally, demonstrating its commitment to combat the COVID-19 pandemic.
Moderna, Inc. (Nasdaq: MRNA) has submitted for conditional marketing approval of its COVID-19 vaccine for adolescents with the European Medicines Agency. The Phase 2/3 TeenCOVE study showed 100% efficacy in nearly 2,500 adolescents receiving two doses. The vaccine demonstrated a strong safety profile with mostly mild adverse events. Moderna plans to file for Emergency Use Authorization with the U.S. FDA and has received various authorizations globally. The company is also committed to monitoring long-term protection and safety for participants.
Moderna (Nasdaq: MRNA) announced a supply agreement with the Government of Botswana for its COVID-19 vaccine, aimed at enhancing access to vaccines in Botswana. The Botswana Medicines Regulatory Authority has granted emergency use authorization for the vaccine in adults 18 and older. This agreement complements an existing contract with Gavi for up to 500 million doses globally. The vaccine has proven effective in increasing neutralizing antibodies against COVID-19 variants. Moderna continues to expand its mRNA platform for various therapeutic areas.
Moderna (Nasdaq: MRNA) has signed a long-term agreement with UNICEF to supply up to 34 million doses of its COVID-19 vaccine in Q4 2021 and 466 million doses in 2022. The doses will be provided at the company's lowest tiered price, supporting global vaccine access through the COVAX Facility. CEO Stéphane Bancel emphasized the commitment to combating the pandemic. Additionally, the WHO granted Emergency Use Listing for the vaccine, enhancing its distribution potential.
Moderna (Nasdaq: MRNA) announced a new agreement with Lonza to enhance drug substance manufacturing, enabling the supply of an additional 300 million doses of its updated COVID-19 booster vaccine candidate annually at a 50 µg dose. This builds on previous investments, allowing for a total of 600 million doses per year from EU production. The company is ramping up production capacity in collaboration with multiple partners, targeting completion by year-end 2021 to meet global demand for its vaccines.
Moderna (Nasdaq: MRNA) has entered a partnership with Thermo Fisher Scientific (NYSE: TMO) for sterile manufacturing services for its COVID-19 vaccine. This collaboration will utilize Thermo Fisher's Greenville, NC facility for fill/finish, labeling, and packaging, enabling the production of hundreds of millions of vaccine doses starting Q3 2021. Moderna's Chief Technical Operations and Quality Officer expressed satisfaction in expanding the relationship to enhance manufacturing capabilities. This agreement highlights Moderna's continued efforts to scale vaccine production amidst the ongoing pandemic.
Moderna (Nasdaq: MRNA) has initiated the rolling submission process for a Biologics License Application (BLA) for its mRNA COVID-19 vaccine aimed at individuals 18 and older. The request includes a Priority Review, with data from ongoing Phase 3 studies being submitted periodically. The vaccine is currently authorized under Emergency Use Authorization (EUA) and has administered over 124 million doses in the U.S. since its EUA grant in December 2020. Moderna continues to innovate with variant-specific booster candidates as part of its COVID-19 response.
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