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 received emergency use authorization from the FDA for its bivalent COVID-19 booster vaccine, mRNA-1273.222, targeting the BA.4/BA.5 Omicron variant. This authorization is applicable for children and adolescents aged 6 to 17. The vaccine consists of two doses: 25 µg for ages 6-11 and 50 µg for ages 12-17. With this approval, Moderna expands its booster options for younger populations as the winter season approaches. The company is also finalizing an EUA application for kids aged 6 months to 5 years, expected to be submitted later this year.
Moderna and Merck announced Merck's exercise of its option to jointly develop personalized cancer vaccine mRNA-4157/V940. This vaccine is being tested in a Phase 2 trial alongside KEYTRUDA for high-risk melanoma patients, with data expected by the end of 2022. Merck will pay Moderna $250 million for this collaboration, which began in 2016. The trial, involving 157 patients, aims to assess the vaccine's effectiveness compared to KEYTRUDA alone, focusing on recurrence-free survival.
Moderna, Inc. (NASDAQ:MRNA) announces strategic leadership changes to bolster its upcoming product launches. Effective January 1, 2023, Juan Andres transitions to President of Strategic Partnerships and Enterprise Expansion, continuing on the Executive Committee. Dr. Jerh Collins joins as Chief Technical Operations and Quality Officer on October 3, 2022, succeeding Andres. Collins brings nearly 30 years of experience in pharmaceutical manufacturing, aiming to expand Moderna's production capabilities. These appointments reflect Moderna's commitment to scaling operations and enhancing its diverse mRNA therapeutics portfolio.
Moderna (NASDAQ: MRNA) has filed for the evaluation of its next-generation bivalent COVID-19 vaccine, mRNA-1273.222, targeting the Omicron BA.4/BA.5 subvariants in adults aged 12 and older. This follows the recent approval of its BA.1 targeting vaccine by the European Medicines Agency (EMA). The filing is backed by preclinical and clinical trial data, and Moderna's Omicron-targeting boosters are currently authorized in various regions, including the U.S., Canada, and Europe. CEO Stépahne Bancel emphasized the importance of these vaccines as winter approaches.
Moderna (NASDAQ:MRNA) announced the approval of its Omicron-targeting bivalent COVID-19 booster, mRNA-1273.214, by Japan's Ministry of Health, Labour and Welfare. This new booster combines mRNA-1273 and a candidate for the Omicron BA.1 variant. The approval is based on Phase 2/3 trial data showing significantly higher antibody responses against Omicron subvariants compared to the previously authorized booster. Moderna is set to supply the vaccine in Japan by September, with distribution support from Takeda Pharmaceutical.
Moderna presented interim data on its mRNA programs at the 2022 R&D Day, focusing on encouraging results from Phase 1/2 trials for mRNA-3927 (Propionic Acidemia) and mRNA-3745 (Glycogen Storage Disease 1a). Both candidates were well-tolerated with signs of potential clinical benefits. New candidate mRNA-3139 for Ornithine Transcarbamylase deficiency was also announced. Additionally, robust enrollment in Phase 3 trials for RSV vaccine (mRNA-1345) and flu vaccine (mRNA-1010) was reported, with plans for accelerated approvals in 2023.
Moderna (NASDAQ:MRNA) announced that President Stephen Hoge, M.D., will participate in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on September 13, 2022, at 10:00 a.m. ET. A live webcast will be available on the Investors section of Moderna's website, with a replay accessible for at least 30 days afterward. Over the past decade, Moderna has evolved into a leader in mRNA therapeutics, having developed vaccines for various diseases, including COVID-19.
Moderna announced that Health Canada has authorized mRNA-1273.214, the first Omicron-targeting bivalent COVID-19 booster vaccine. Clinical trials show that it produces significantly higher antibody levels against Omicron subvariants than mRNA-1273. The company has an agreement with the Government of Canada for the supply of 12 million doses, with an additional 4.5 million doses ordered. This approval is part of Moderna's efforts to combat the spread of COVID-19 as the cold season approaches.
Moderna announced a positive opinion from the European Medicines Agency's (EMA) committee recommending conditional marketing authorization for its bivalent COVID-19 vaccine, mRNA-1273.214. This vaccine targets the Omicron variant and has shown significantly higher antibody responses compared to the original version. Furthermore, the European Commission is expected to make a decision on its use as a booster for individuals 12 and older. Moderna has also secured approvals in Australia, Switzerland, and the UK, reflecting a strong market presence.
Moderna, Inc. (MRNA) has received emergency use authorization from the FDA for its new bivalent COVID-19 booster vaccine, mRNA-1273.222, targeting the Omicron BA.4/.5 variants. This booster is available for adults over 18 who have previously received COVID-19 vaccinations. The 50 µg booster dose includes mRNA for both the original virus strain and the BA.4/.5 variants. The vaccine aims to enhance public health protection against the ongoing pandemic, especially with increasing indoor gatherings. Doses are expected to be available nationwide soon.
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