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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) has signed a supply agreement with the Australian government for 25 million COVID-19 vaccine doses. This includes 10 million doses of the original mRNA-1273 vaccine and 15 million doses of an updated variant booster, pending regulatory approval. Moderna plans to submit an application to the Therapeutic Goods Administration of Australia. Additionally, the Company aims to establish a commercial subsidiary in Australia this year. Initial data from a Phase 2 study show increased antibody responses with booster doses, indicating efficacy against variants of concern.
Moderna (Nasdaq: MRNA) announced that CFO David Meline and SVP Lavina Talukdar will partake in a fireside chat at the Bank of America 2021 Healthcare Conference on May 13, 2021, at 11:00 a.m. ET. The event will be available via live webcast on Moderna's investor website, with a replay accessible for 30 days post-event.
Since its inception, Moderna has evolved from a research-stage company to a leader in mRNA therapeutics and vaccines, currently advancing 24 development programs, including 13 in clinical stages.
Moderna, Inc. (Nasdaq: MRNA) reported its first profitable quarter, aiding over 100 million individuals with its COVID-19 vaccine. The company raised its supply forecast for 2021 to 800 million doses, aiming for 1 billion. Promising data from recent clinical trials indicate a 96% vaccine efficacy in adolescents and strong responses to variant booster doses. Additionally, Moderna is expanding its pipeline with 24 mRNA programs, including candidates for RSV and CMV vaccines. The company is set to initiate its Biologics License Application for its COVID-19 vaccine this month.
Moderna (Nasdaq: MRNA) announced a new supply agreement with the Swiss Federal Government to deliver 7 million doses of its booster vaccine in 2022, with an option for an additional 7 million doses for late 2022 or early 2023, contingent on regulatory approval. This follows prior agreements totaling 13.5 million doses. Data from a Phase 2 study indicates that booster doses increased neutralizing antibody responses against SARS-CoV-2 variants. Safety profiles for the booster were comparable to prior doses. Moderna continues to adapt its vaccine to combat emerging variants.
Moderna (MRNA) announced promising data from its Phase 2 study, demonstrating that a 50 µg booster dose of its mRNA-1273.351 vaccine significantly increases neutralizing antibody titers against SARS-CoV-2 and its variants, B.1.351 and P.1. The study found a boost in titers for all participants following the booster. mRNA-1273.351 outperformed mRNA-1273 against B.1.351, with a geometric mean titer of 1400 compared to 864. Safety profiles were comparable to previous doses, with mild to moderate adverse effects. Future data on the multivalent booster mRNA-1273.211 is anticipated.
Moderna, Inc. (Nasdaq: MRNA) has announced an expansion of the Moderna Technology Center in Norwood, MA, set to more than double its space from 300,000 to 650,000 square feet. This growth will enhance production capabilities, particularly for the COVID-19 vaccine, expecting a 50% increase in output by early 2022. The expansion supports plans for global capacity reaching up to 3 billion doses in 2022, and focuses on technical development and preclinical production. The facility integrates advanced technologies and adheres to environmental standards.
Moderna, Inc. (Nasdaq: MRNA) has signed an agreement with Gavi, the Vaccine Alliance to supply up to 500 million doses of its COVID-19 vaccine, including an initial 34 million doses in Q4 2021. This deal supports low- and middle-income countries via the COVAX Facility, furthering Moderna’s commitment to equitable vaccine access. Additionally, the World Health Organization has granted Emergency Use Listing for Moderna's vaccine, enhancing its global reach. The agreement highlights Moderna's pivotal role in combating the COVID-19 pandemic.
Moderna, Inc. (Nasdaq: MRNA) announced the World Health Organization's (WHO) issuance of an Emergency Use Listing (EUL) for its COVID-19 vaccine, applicable to individuals 18 and older. This listing facilitates regulatory approvals for countries and enables UNICEF to procure the vaccine. Based on extensive clinical study data, the EUL promotes faster access to vaccines globally, particularly in lower-income regions. CEO Stéphane Bancel emphasized the significance of this step in combating the COVID-19 pandemic, ensuring equitable vaccine access worldwide.
Moderna (Nasdaq: MRNA) has announced new funding commitments to enhance manufacturing capabilities, aiming to increase its global COVID-19 vaccine supply to up to 3 billion doses in 2022. This capacity boost involves doubling production at Lonza in Switzerland and over doubling at Rovi in Spain. The company is also in advanced negotiations for further agreements. Moderna expects heightened demand for vaccines due to the emergence of variants and waning immunity. The company aims to enhance its vaccine's shelf life and is actively developing new formulations.
DNA Script announced a partnership with Moderna (MRNA) to develop a prototype for mobile vaccine and therapeutic manufacturing under DARPA's Nucleic Acids On-Demand World-Wide Program. This collaboration will utilize DNA Script's enzymatic synthesis platform to produce high-fidelity nucleic acids, enhancing Moderna's mRNA technology. DNA Script will receive up to $5 million in grant funding from DARPA. The initiative aims to create mobile units for rapid production of mRNA vaccines, potentially offering immediate medical responses to pathogen threats.