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 (NASDAQ:MRNA) announced that Health Canada has authorized its second bivalent COVID-19 booster vaccine, mRNA-1273.222, which targets the Omicron BA.4/BA.5 subvariants. This authorization follows the earlier approval of mRNA-1273.214 in September 2022. The 50 µg booster dose comprises mRNA for both BA.4/BA.5 and the original SARS-CoV-2 strain. The approval is based on pre-clinical data and ongoing Phase 2/3 trials. This development underscores Moderna's rapid vaccine innovation capabilities to combat emerging COVID-19 variants.
Moderna reported Q3 2022 revenues of $3.4 billion, down from $5.0 billion in Q3 2021, primarily due to declining COVID-19 vaccine sales. The company expects $18-$19 billion in revenue from advance purchase agreements for 2022, with some delivery delays pushing $2-$3 billion to 2023. GAAP net income dropped 69% to $1.0 billion, while diluted EPS fell 67% to $2.53. Moderna completed a $3 billion share repurchase plan and continues to progress in multiple vaccine developments, including RSV and flu candidates.
Moderna, Inc. (NASDAQ: MRNA) announced that its Omicron-targeting bivalent COVID-19 booster, mRNA-1273.222, received approval from Japan's Ministry of Health, Labour and Welfare. This booster is designed for adults aged 18 and older and contains mRNA-1273 and a variant-targeting component. The approval aims to provide a stronger immune response against circulating Omicron subvariants in Japan. The Phase 2/3 trial for the vaccine is ongoing, supported by Takeda Pharmaceutical Co. for distribution during Japan's national vaccination campaign.
Moderna (Nasdaq: MRNA) has received a positive opinion from the European Medicines Agency's CHMP recommending conditional marketing authorization for mRNA-1273.222 (Spikevax bivalent Original/Omicron BA.4-5) as a booster for individuals aged 12 and older. This follows the recent approval of the mRNA-1273.214 vaccine targeting Omicron BA.1. The bivalent vaccine mRNA-1273.222 aims to provide protection against Omicron subvariants as winter approaches. Initial data from a Phase 2/3 trial is expected later this year, enhancing Moderna's position in the COVID-19 vaccine market.
Moderna has received a positive opinion from the European Medicines Agency's CHMP to include its COVID-19 vaccine, Spikevax (mRNA-1273), for children aged 6 months to 5 years. This follows positive interim results from the KidCOVE study, which showed robust antibody responses and safety for this age group. The two-dose series, comparable in efficacy to adults, takes one month to complete. The authorization decision by the European Commission is forthcoming, expanding vaccination options for young children, particularly at risk from COVID-19.
Moderna, Inc. (NASDAQ:MRNA) has announced positive clinical results for its bivalent booster, mRNA-1273.214, showing a durable immune response against COVID-19 variants. New data revealed that 90 days post-administration, the booster generated superior neutralizing antibody responses against Omicron BA.1 compared to its previous version. The booster also effectively targets variants BA.4/BA.5 and BA.2.75. Safety profiles remained consistent with earlier doses, with no new safety concerns reported. Comprehensive data will be presented at ID Week on October 20, 2022.
Moderna and Gavi have mutually decided to cancel pending orders for COVID-19 vaccines for 2022. Instead, they will establish a new agreement allowing Gavi to procure up to 100 million doses of updated variant-specific vaccines in 2023 at Moderna's lowest price tier. Moderna has delivered nearly 70 million doses to low- and middle-income countries through Gavi's COVAX initiative, also facilitating over 100 million donations. This agreement aims to ensure equitable access to COVID-19 vaccines for vulnerable populations.
Moderna, Inc. (NASDAQ:MRNA) has scheduled a live conference call for November 3, 2022, at 8:00 a.m. ET to discuss its Q3 2022 financial results and provide a corporate update. The call will be accessible via telephone with prior registration, and a live webcast will also be available on their website. Moderna has evolved from a research-stage company into a leader in mRNA therapeutics and vaccines, focusing on various diseases, including COVID-19. The archived webcast will be accessible for a year post-call.
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