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 (MRNA) is in discussions with the South Korean government to supply 40 million COVID-19 vaccine doses, with distribution planned to start in Q2 2021. The vaccine has received emergency use authorization but is not fully approved by the FDA. Moderna focuses on mRNA therapeutics and vaccines across various diseases, supported by alliances with major pharmaceutical companies. However, the company acknowledges risks related to regulatory approval, manufacturing, and vaccine efficacy, which may impact its financial outlook.
Moderna (Nasdaq: MRNA) announced CEO Stéphane Bancel's virtual participation in the Goldman Sachs 13th Annual Healthcare CEOs Unscripted Conference on January 5, 2021, at 8:00 a.m. ET. A live webcast will be accessible in the Investors section on the Moderna website, with a replay available for 90 days post-event. Moderna is pioneering mRNA science to create transformative medicines, addressing various diseases through a robust pipeline of therapeutics and vaccines, in collaboration with strategic partners like AstraZeneca and Merck.
Moderna, Inc. (Nasdaq: MRNA) announced that Health Canada has authorized its COVID-19 vaccine for individuals 18 and older under an Interim Order. This decision reflects a comprehensive review, including data from the Phase 3 COVE study with 30,000 participants. The Canadian government has increased its confirmed order for the vaccine by 20 million doses, totaling 40 million doses. The vaccine, which utilizes mRNA technology, is designed to protect against COVID-19. Moderna emphasizes ongoing collaboration with regulatory bodies to ensure vaccine efficacy and safety.
Moderna (Nasdaq: MRNA) announced that the CDC's ACIP has recommended the use of its COVID-19 vaccine for individuals aged 18 and older under an Emergency Use Authorization (EUA). This recommendation follows previous guidelines prioritizing healthcare workers for vaccination. The vaccine has been authorized for distribution following FDA approval on December 18, 2020. Moderna aims to provide 100-125 million doses globally by Q1 2021, with 85-100 million for the U.S. Under Operation Warp Speed, 20 million doses are expected by December's end.
Moderna, Inc. (Nasdaq: MRNA) has received Emergency Use Authorization (EUA) from the FDA for its COVID-19 vaccine, mRNA-1273, for individuals aged 18 and older. Delivery of approximately 20 million doses to the U.S. government will begin immediately, with 100-125 million doses expected globally in Q1 2021. The vaccine demonstrated a 94.1% efficacy rate in a pivotal Phase 3 trial involving 30,000 participants. Moderna plans to file a Biologics License Application in 2021 to seek full licensure.
Moderna (Nasdaq: MRNA) announced that the European Commission has increased its order for the COVID-19 vaccine mRNA-1273 by 80 million doses, totaling 160 million doses. The initial deliveries are set to begin early 2021, pending regulatory approval from the EMA. The CEO expressed gratitude for this confidence, while Moderna has confirmed supply agreements totaling over 470 million doses across multiple countries. The company is preparing for distribution in case it receives market authorization.
Moderna, Inc. (Nasdaq:MRNA) announced that the FDA’s advisory committee recommended Emergency Use Authorization (EUA) for its COVID-19 vaccine candidate, mRNA-1273. The recommendation received an overwhelming positive vote with 20 in favor and 0 against. The vaccine demonstrated a 94.1% efficacy rate based on a Phase 3 clinical study involving over 30,000 participants. The company is aiding distribution efforts while ensuring that mRNA-1273 can be transported at standard refrigerator temperatures. The FDA will consider this recommendation for its final decision on EUA.
Moderna, Inc. (Nasdaq: MRNA) has reached an agreement with Singapore's Ministry of Health to supply mRNA-1273, its COVID-19 vaccine candidate. The Phase 3 COVE study, which included 30,000 participants, demonstrated an efficacy of 94.1% against COVID-19 and 100% against severe cases. Safety data reveal common reactions like fatigue and headache, primarily after the second dose. Moderna plans to deliver approximately 500 million doses annually, with potential scalability to up to 1 billion doses. The vaccine remains stable at refrigerator temperatures for 30 days.
Moderna, Inc. (Nasdaq: MRNA) announced the U.S. government's option exercise for an additional 100 million doses of its COVID-19 vaccine candidate, mRNA-1273, raising the total to 200 million doses. The company will deliver approximately 20 million doses by December 2020, with the remaining to follow in early 2021. The new order is set for delivery in Q2 2021, pending Emergency Use Authorization (EUA) from the FDA. Moderna continues to strengthen its manufacturing capabilities while working with the U.S. government and global stakeholders to distribute mRNA-1273.
Moderna Inc. (Nasdaq: MRNA) has initiated a Phase 2/3 clinical trial for its COVID-19 vaccine candidate, mRNA-1273, targeting adolescents aged 12 to less than 18. This study, supported by BARDA, aims to enroll 3,000 participants in the U.S. and evaluate safety, reactogenicity, and immunogenicity with two vaccinations 28 days apart. Results are expected in spring 2021 to inform potential use ahead of the school year. The vaccine, co-developed with NIAID, is not yet approved for use.
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