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 the FDA has granted Fast Track designation for its investigational mRNA-1345, a single-dose vaccine against respiratory syncytial virus (RSV) targeting adults over 60. The vaccine aims to protect vulnerable populations, such as older adults and young children, as RSV leads to significant hospitalizations and deaths annually. Moderna is conducting ongoing clinical trials for mRNA-1345 and plans to assess its combinations with other vaccines. The company has previously received Fast Track designations for several other vaccine candidates.
Moderna (Nasdaq: MRNA) has dosed its first participant in the Phase 1 study of mRNA-6231, its first autoimmune candidate designed to expand regulatory T cells. This marks a significant milestone as it is also the company's first subcutaneously administered therapeutic. The trial aims to evaluate the safety and tolerability of mRNA-6231 in healthy adults. Moderna continues to advance its mRNA platform with programs in various therapeutic areas, highlighting its commitment to addressing autoimmune diseases.
Moderna (MRNA) announced a positive recommendation from the European Medicines Agency’s CHMP for its COVID-19 vaccine, Spikevax, to include adolescents aged 12 and older. This follows the successful Phase 2/3 study showing 100% vaccine efficacy post-second dose in this age group. The European Commission will consider final authorization, which could help in the return to school for adolescents. The vaccine has been well-tolerated, with most adverse events being mild. Moderna is also conducting further studies for younger children.
Moderna, Inc. (MRNA) announced a supply agreement with Taiwan for 20 million doses of its COVID-19 vaccine and an updated variant booster candidate, pending authorization, for delivery starting in 2022 and extending to 15 million additional doses in 2023. This agreement follows a prior contract for 5 million doses in 2021. CEO Stéphane Bancel expressed gratitude towards Taiwan for their support in this collaboration, emphasizing Moderna's commitment to global vaccine availability.
Moderna (Nasdaq: MRNA) has announced an agreement with Japan's Ministry of Health and Takeda Pharmaceutical for an additional 50 million doses of its COVID-19 vaccine, bringing the total to 100 million doses for Japan. Delivery is set to begin in 2022, with Moderna responsible for manufacturing and supply, while Takeda will handle distribution and regulatory matters. CEO Stéphane Bancel expressed gratitude for the partnership aimed at addressing the pandemic. Moderna's mRNA technology has been pivotal in its rapid growth as a leading biotechnology company.
Moderna, Inc. (Nasdaq: MRNA) will host a live conference call and webcast on August 5, 2021, at 8:00 a.m. ET to discuss its second quarter 2021 financial results and provide a corporate update. To participate, call 866-922-5184 (domestic) or 409-937-8950 (international) with conference ID 5749439. The call will also be available via webcast on Moderna's investor website. Since its inception, Moderna has shifted to a leading biotechnology company with a diverse vaccine and therapeutics portfolio, particularly recognized for its COVID-19 vaccine.
Moderna, Inc. (Nasdaq: MRNA) announced a supply agreement with the government of Argentina for 20 million doses of its COVID-19 vaccine, including potential updated variant boosters, slated for delivery starting Q1 2022. CEO Stéphane Bancel highlighted the company’s commitment to global vaccine availability. Moderna has received emergency use authorization for its vaccine in over 50 countries and is advancing multiple programs across infectious diseases and other therapeutic areas, showcasing robust manufacturing capabilities and ongoing clinical trials.
Moderna (Nasdaq: MRNA) has initiated the Phase 1/2 study of its mRNA-1010 vaccine, targeting seasonal influenza. The study involves approximately 180 healthy adults aged 18 and older in the U.S. The quadrivalent vaccine aims to protect against significant influenza lineages as recommended by WHO. This is Moderna's first seasonal influenza vaccine candidate entering clinical trials, marking a significant step in its mRNA vaccine strategy. The company envisions developing combination vaccines for multiple respiratory viruses, aiming to enhance public health response.
Moderna (Nasdaq: MRNA) has commenced the manufacturing of its COVID-19 vaccine at Recipharm’s Monts site in France, following the European Medicines Agency's approval on June 11, 2021. This collaboration aims to bolster vaccine production capacity in Europe, essential for ongoing vaccination efforts. Moderna's recent investments are set to double drug substance manufacturing across Europe and enhance safety stock of raw materials. The COVID-19 Vaccine Moderna has received marketing authorization in 49 countries and is integral to Moderna's strategic growth in mRNA therapeutics.
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