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) announces that Health Canada has granted full approval for SPIKEVAX (elasomeran mRNA vaccine), previously known as COVID-19 Vaccine Moderna. This marks a significant milestone as it's the first complete approval for SPIKEVAX. The approval is based on Phase 3 COVE study results, showing 93% efficacy with sustained protection for six months post-second dose. SPIKEVAX is indicated for individuals aged 12 and older, expanding its earlier emergency use for adults and adolescents. The company expresses gratitude towards Health Canada and the Canadian Government for their collaboration.
Moderna (MRNA) announces that its COVID-19 vaccine, mRNA-1273, remains highly effective against the Delta variant. A study involving 352,878 vaccinated individuals indicated an effectiveness rate of 87% against COVID-19 diagnosis and 96% against hospitalization. An analysis of their Phase 3 COVE study revealed a 36% reduction in breakthrough infections for those vaccinated more recently compared to those vaccinated earlier. The company advocates for a booster dose to enhance immunity and will share findings in a conference call.
Moderna, Inc. (NASDAQ: MRNA) has made significant advancements in its mRNA vaccine pipeline, as announced during its fifth annual R&D Day. Key highlights include the development of a combination respiratory vaccine for COVID-19 and flu, and a pediatric vaccine for RSV and hMPV. Interim Phase 1 data showed boosted neutralizing antibody titers in older adults for the RSV candidate. Additionally, a personalized cancer vaccine trial is fully enrolled. Moderna currently has 37 programs in development, including 22 in clinical studies.
Moderna, Inc. (MRNA) has partnered with National Resilience, Inc. to manufacture mRNA for its COVID-19 vaccine. This multi-year agreement will utilize Resilience's facility in Mississauga, Ontario, ensuring global distribution of the vaccine. The collaboration aims to broaden access to Moderna's vaccines and enhance pandemic response capabilities. Additionally, Moderna has initiated a collaboration with Canada to establish a state-of-the-art mRNA manufacturing facility, further solidifying its commitment to expanding healthcare solutions against respiratory viruses.
National Resilience, Inc. and Moderna, Inc. have entered a multi-year agreement for the manufacturing of mRNA for the Moderna COVID-19 vaccine. The mRNA will be produced at Resilience's facility in Mississauga, Ontario, for global distribution. Resilience's CEO, Rahul Singhvi, highlighted the impact of Moderna’s vaccine in saving lives and expressed excitement about this partnership, which aims to enhance vaccination efforts worldwide.
Moderna has announced a collaboration with the Institute for Life Changing Medicines (ILCM) to develop an mRNA therapy, mRNA-3351, for Crigler-Najjar Syndrome Type 1 (CN-1), an ultra-rare genetic disorder affecting about 70-100 individuals globally. This partnership aims to provide the therapy free of charge to patients. Moderna will license mRNA-3351 to ILCM without upfront fees, and ILCM will handle clinical development, projected to start in 2022. This initiative reflects Moderna's commitment to addressing rare diseases without imposing high costs on patients.
Moderna, Inc. (Nasdaq: MRNA) has submitted a request for conditional marketing approval to the European Medicines Agency (EMA) for its COVID-19 vaccine booster dose, mRNA-1273, at a 50 µg level. The amended Phase 2 study involving 344 participants showed that this booster significantly increases antibody responses, particularly against the Delta variant, boosting neutralizing titers above Phase 3 benchmarks. The safety profile after the third dose was similar to that of the second dose, indicating the potential for effective ongoing immunity against COVID-19.
Moderna (NASDAQ: MRNA) announced participation in two virtual investor conferences on September 10, 2021. The Wells Fargo 2021 Virtual Healthcare Conference will begin at 10:00 a.m. ET, followed by the Morgan Stanley 19th Annual Global Healthcare Conference at 11:45 a.m. ET. Live webcasts can be accessed on the Moderna Investors website and will be available for replay for 30 days. Moderna has emerged as a leader in mRNA therapeutics, developing vaccines and treatments across various therapeutic areas.
Moderna (NASDAQ:MRNA) has submitted data to the FDA for a booster dose of its COVID-19 vaccine (mRNA-1273) at a 50 µg dose level. The submission is backed by Phase 2 study data showing significant antibody responses against the Delta variant, exceeding benchmarks. Following the booster, neutralizing antibody titers increased significantly, especially in older adults. The safety profile remained consistent with previous doses. Moderna plans to submit further data to the EMA and other global authorities soon.
Moderna has completed its Biologics License Application (BLA) for the COVID-19 vaccine, requesting Priority Review from the FDA. The final analysis of the Phase 3 COVE study shows the vaccine has a 93% efficacy rate, which remains durable for six months after the second dose. This marks the first BLA submission in Moderna's history. The company aims for full licensure to prevent COVID-19 in individuals aged 18 and older. The vaccine has been available under Emergency Use Authorization since December 2020 and has delivered over 300 million doses to the U.S. government.
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