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) will host its fifth annual virtual R&D Day for analysts and investors on September 9 at 8:00 a.m. ET. Key presentations will be made by CEO Stéphane Bancel, Chief Medical Officer Paul Burton, and other leaders, focusing on Moderna's clinical development pipeline. Registration for the event can be done here. The webcast will also be available on Moderna's investor website and archived for one year.
Azzur Cleanrooms on Demand has expanded its partnership with Moderna, aiming to enhance clinical manufacturing capabilities. This collaboration spans over six years, with Moderna becoming the anchor client at Azzur's new Burlington, MA facility. The partnership aims to tackle production challenges and meet the growing demand for Moderna's products as they expand their clinical manufacturing capacity. Azzur operates multiple COD facilities across the U.S. and plans further expansion into new markets in the coming months.
Moderna, Inc. (Nasdaq: MRNA) announced a revised supply agreement with the Government of Canada for up to 105 million doses of its COVID-19 vaccine through 2024. The agreement stipulates 20 million doses in 2022 and 2023, with an option for an additional 15 million doses each year. For 2024, it allows for up to 35 million doses. Moderna's CEO, Stéphane Bancel, commended the Canadian government's support. This agreement further illustrates Moderna's role in combating the pandemic and highlights the company's ongoing collaboration with governmental partners.
Moderna (Nasdaq: MRNA) has commenced a Phase 1/2 trial for mRNA-3705, an investigational therapy targeting methylmalonic acidemia (MMA) caused by MUT deficiency. The first patient has been enrolled in the study assessing the safety and tolerability of this mRNA therapeutic. MMA is a rare metabolic disorder with no approved treatments, and current options are limited to dietary management and transplants. mRNA-3705 aims to restore missing enzymes to improve patient outcomes. The FDA has granted it Orphan Drug and Rare Pediatric Disease designations.
Moderna, Inc. (Nasdaq: MRNA) announced FDA approval for a third dose of its COVID-19 vaccine (mRNA-1273) for immunocompromised individuals 18 and older. This decision is based on recent studies indicating enhanced immune responses in this population. The vaccine has previously received emergency use authorization and is actively utilized across over 50 countries. Moderna's CEO emphasized the commitment to improving protection against COVID-19, particularly for those at higher risk. The company continues to research the vaccine's effectiveness against variants.
Moderna, Inc. (Nasdaq:MRNA) announced new findings regarding the effectiveness of its COVID-19 vaccine, demonstrating durable neutralizing antibodies against several variants, including Delta, for up to six months post-vaccination. The study highlights that 93% efficacy is maintained over this period, with most participants retaining detectable antibody levels. While a slight decrease in antibody levels was noted, especially in older individuals, many preserved their neutralizing activity. This data aims to inform health regulators about potential booster doses.
Moderna (Nasdaq: MRNA) has signed a Memorandum of Understanding with the Canadian government to establish a new mRNA vaccine manufacturing facility in Canada. This facility aims to enhance Canada's pandemic response capabilities and provide access to Moderna's vaccines for respiratory viruses, including COVID-19. CEO Stéphane Bancel emphasized the collaboration's significance in global public health, stating the company's commitment to leveraging mRNA technology. The partnership is expected to foster Moderna's presence in Canada and further develop its mRNA portfolio.
Moderna (Nasdaq: MRNA) has received provisional registration from Australia’s Therapeutic Goods Administration for its COVID-19 Vaccine, authorized for individuals aged 18 and over. Vaccine delivery is set to begin in September 2021. The Australian government secured 10 million doses for 2021 with an option for an additional 15 million in 2022. Aside from Australia, Moderna has received approvals from over 50 countries and the WHO for its vaccine. Ongoing evaluations for adolescent use are underway, highlighting the vaccine's broad acceptance and demand.
Moderna (Nasdaq: MRNA) reported Q2 2021 financial results with total revenue of $4.4 billion, a significant increase from $67 million in Q2 2020, driven primarily by COVID-19 vaccine sales. The company expects dose capacity to range from 800 million to 1 billion doses in FY 2021. Moderna's COVID-19 vaccine shows a durable efficacy of 93% over six months. The company is advancing multiple mRNA candidates across therapeutic areas, including upcoming Phase 3 trials for RSV and flu vaccines, and has received Fast Track designation for its RSV vaccine.
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