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) announced that the FDA requires more time to assess the company's EUA request for the COVID-19 vaccine (mRNA-1273) for adolescents aged 12 to 17. The FDA's review may extend beyond January 2022 due to concerns about myocarditis risk following vaccination. Despite over 1.5 million adolescents vaccinated, Moderna's safety data does not indicate an increased myocarditis risk in this group. Additionally, the filing for pediatric EUA (6-11 years) will be delayed until the FDA completes its review.
Moderna has announced an agreement with Gavi to supply 116.5 million doses of its COVID-19 vaccine in Q2 2022, increasing from a previous 60 million doses. This agreement includes options for an additional 233 million doses under the COVAX Facility, potentially totaling 500 million doses for 2021-2022. All doses will be offered at the lowest tiered price, supporting global access initiatives. The partnership aims to provide vaccines to 92 low- and middle-income countries.
Moderna (NASDAQ: MRNA) announces its participation in two upcoming virtual investor conferences:
- Bernstein Operational Decisions Conference on November 4, 2021 at 4:30 p.m. ET
- Credit Suisse 30th Annual Healthcare Conference on November 8, 2021 at 1:50 p.m. ET
Live webcasts will be available in the Investors section of Moderna's website and will be archived for at least 30 days post-event. Moderna, a leader in mRNA therapeutics, continues to innovate in vaccine development, notably against COVID-19.
Moderna announced the initiation of the Phase 3 pivotal registration study for mRNA-1647, its cytomegalovirus (CMV) vaccine candidate, marking a significant milestone as it is the second Phase 3 study in the company's history. The CMVictory study aims to enroll around 8,000 participants, primarily women aged 16-40. CMV is the leading infectious cause of birth defects in the U.S., with 1 in 200 babies affected. mRNA-1647 combines six mRNAs targeting CMV proteins and has previously shown promising results in Phase 1 and 2 studies.
Moderna has received authorization from Swissmedic for a 50 µg booster dose of its COVID-19 vaccine, Spikevax, for vulnerable individuals aged 12 and older, at least six months after the primary series. Additionally, a third dose at 100 µg is approved for immunocompromised persons at least 28 days post-second dose. The approvals are backed by clinical data indicating a strong immune response. CEO Stéphane Bancel expressed gratitude for the support, emphasizing the significance of mRNA vaccines against evolving COVID-19 variants.
Moderna has signed a new Memorandum of Understanding (MoU) to provide up to 110 million doses of its COVID-19 vaccine to the African Union. Initial deliveries include 15 million doses in Q4 2021 and 35 million doses in Q1 2022. Moderna will supply these doses at its lowest tiered price as part of its global access commitments. The company is also planning to establish a mRNA vaccine manufacturing facility in Africa by 2023, aiming to produce 500 million doses annually, showcasing its commitment to improve vaccine access in low-income countries.
Moderna (Nasdaq: MRNA) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has approved a booster dose of its COVID-19 vaccine, Spikevax, at a 50 µg level for individuals aged 18 and older, six months post-primary series completion. This recommendation is based on clinical evidence demonstrating a strong immune response, particularly against variants. The safety profile for the booster dose mirrors that of the second dose. Moderna continues to adapt its mRNA technology to respond to evolving COVID-19 challenges.
Moderna announced positive interim data from the KidCOVE study, evaluating its COVID-19 vaccine, mRNA-1273, in children aged 6 to under 12 years. The trial demonstrated robust neutralizing antibody responses after two 50 μg doses and met primary immunogenicity endpoints. A seroresponse rate of 99.3% was reported, indicating a strong immune response. Moderna plans to submit the results to the FDA and EMA for regulatory review. The safety profile appeared consistent with previous studies, with most adverse events being mild to moderate.
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