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) has announced its participation in two upcoming virtual investor conferences. The Jefferies Virtual Healthcare Conference will take place on June 3, 2021, at 10:00 a.m. ET, followed by the Goldman Sachs 42nd Annual Healthcare Conference on June 9, 2021, at 8:00 a.m. ET. Live webcasts of both events will be accessible on the Investors section of Moderna's website, and replays will be available for 30 days post-event. Moderna has evolved significantly in its 10-year history, establishing a strong clinical portfolio and a robust mRNA platform for various diseases.
Moderna, Inc. (Nasdaq: MRNA) held its fourth annual Science Day to showcase developments in mRNA therapeutics and vaccines. The event highlights 24 mRNA programs, with 14 in clinical studies, and focuses on the advancements in mRNA delivery, particularly targeting hematopoietic stem cells, and optimizing mRNA engineering for enhanced protein expression. The company is also leveraging AI to address SARS-CoV-2 variants. These efforts underscore Moderna's continuous commitment to innovation in utilizing mRNA for therapeutic purposes.
Moderna (Nasdaq: MRNA) announced that its Phase 2/3 study of the COVID-19 vaccine (mRNA-1273) in adolescents (ages 12-17) successfully met its primary immunogenicity endpoint. The study, enrolling over 3,700 participants, showed no COVID-19 cases in the vaccine group after two doses, achieving 100% efficacy under adult case definitions. Additionally, a 93% efficacy was noted in seronegative participants using a secondary CDC definition after the first dose. The safety profile was consistent with adult studies, prompting plans to submit findings for global regulatory approval in early June.
Moderna (Nasdaq:MRNA) has expanded its collaboration with Aldevron, enhancing support for both the Moderna COVID-19 Vaccine and its clinical development pipeline. Aldevron will supply plasmid DNA, which is essential for generating the mRNA vaccines. This partnership, spanning nearly a decade, aims to leverage Aldevron's manufacturing capabilities, including a newly expanded GMP facility in Fargo, North Dakota. Moderna continues to work on a diverse range of programs, including various therapeutics and vaccines, while maintaining strategic alliances to maximize their operational efficiency.
Moderna (Nasdaq: MRNA) has entered into a Manufacturing Services and Supply Agreement with Samsung Biologics to conduct large-scale commercial fill-finish manufacturing of its COVID-19 vaccine, mRNA-1273. The technology transfer will start immediately at Samsung's Incheon facility, aiming to produce hundreds of millions of doses for markets outside the U.S. by Q3 2021. This partnership enhances Moderna's manufacturing capacity, crucial during the ongoing pandemic. Both companies emphasize the urgency in supplying the vaccine globally.
Moderna has signed two Memoranda of Understanding (MoUs) with the South Korean government to enhance mRNA vaccine research and explore local manufacturing opportunities. The collaborations involve the Korea National Institute of Health and the Ministry of Trade, Industry, and Energy. Additionally, Moderna has entered into a Manufacturing Services and Supply Agreement with Samsung Biologics for COVID-19 vaccine production. Moderna aims to establish a commercial subsidiary in South Korea in 2021, which will support its growing commercial network in the region.
Moderna, Inc. (Nasdaq: MRNA) has received Conditional Marketing Authorization from South Korea's Ministry of Food and Drug Safety for its COVID-19 mRNA vaccine. GC Pharma will distribute the vaccine in South Korea, which has secured 40 million doses. Moderna plans to establish a commercial subsidiary in South Korea in 2021 and is in discussions for local manufacturing opportunities. The vaccine is authorized for adults aged 18 and older, with approvals also secured in multiple countries and from the World Health Organization.
Moderna, Inc. (Nasdaq: MRNA) announced the Ministry of Health, Labour and Welfare (MHLW) of Japan granted emergency use approval for its mRNA COVID-19 vaccine, COVID-19 Vaccine Moderna Intramuscular Injection. Distribution, facilitated by Takeda, starts immediately. This marks Moderna's first product approval in Japan, following positive Phase 3 COVE study results. The vaccine is authorized for adults 18 and older, and initial trials showed an immune response in all participants. Moderna plans to expand its commercial presence in Japan.
Moderna (Nasdaq: MRNA) will host a virtual Science Day for analysts and investors on May 27 at 8:00 a.m. ET. The event will feature presentations from President Stephen Hoge and Chief Scientific Officer Melissa Moore, focusing on the latest advancements in the company's messenger RNA research. A live webcast will be accessible on the Moderna website, and a replay will be available for one year. Moderna has established itself as a leader in mRNA therapeutics and vaccines, with 24 development programs and 14 in clinical trials.
Moderna, Inc. (Nasdaq: MRNA) announced plans to establish an International Business Services Hub in Warsaw, Poland, enhancing its global operational infrastructure. The Moderna International Business Services (MIBS) Center will provide essential services including finance, pharmacovigilance, human resources, and digital services, creating approximately 160 jobs upon full operation by Q3. CEO Stéphane Bancel highlighted Warsaw's favorable business conditions as key to the expansion, which aims to support Moderna’s growing international business and improve operational efficiency.
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