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 has received Health Canada approval for its updated COVID-19 vaccine, SPIKEVAX® KP.2 variant, for individuals aged six months and older. This marks the first authorized updated COVID-19 vaccine in Canada for 2024-2025. The vaccine targets the KP.2 sub-lineage of SARS-CoV-2 and is expected to provide better protection against circulating strains compared to earlier versions.
Moderna will promptly begin delivering the updated vaccines to the Public Health Agency of Canada, ensuring ample supply for provincial and territorial vaccination campaigns. The approval is based on manufacturing and pre-clinical data, along with previous clinical, non-clinical, and real-world evidence supporting the efficacy and safety of Moderna's mRNA vaccines.
Moderna's R&D Day highlights strategic priorities and progress in its mRNA pipeline. Key points include:
- Targeting 10 product approvals by 2027
- Submitting next-generation COVID and flu/COVID combination vaccines for approval in 2024
- Positive Phase 3 results for RSV vaccine in high-risk adults 18-59
- Positive Phase 3 results for standalone flu vaccine in adults 65+
- Advancing norovirus vaccine to Phase 3
- Implementing cost efficiencies to reduce R&D expense by $1.1 billion by 2027
- Updating financial framework through 2028
The company is focusing on delivering these products while slowing new R&D investments and building its commercial business.
Carisma Therapeutics Inc. (Nasdaq: CARM) has expanded its collaboration with Moderna, Inc. (Nasdaq: MRNA) to develop in vivo CAR-M therapies for autoimmune diseases. This expansion builds on their successful pre-clinical oncology data and includes the nomination of two autoimmune disease targets by Moderna. Carisma will receive research funding and is eligible for milestone and royalty payments.
The collaboration leverages Carisma's proprietary CAR-M technology and Moderna's mRNA/LNP platform. Carisma will handle discovery and optimization of development candidates, while Moderna will lead clinical development and commercialization. This partnership aims to revolutionize treatments for autoimmune conditions, expanding the potential of CAR-M technology beyond oncology.
Moderna's manufacturing facility in Laval, Quebec, has received a Drug Establishment License (DEL) from Health Canada, marking a significant step towards producing mRNA vaccines in Canada by 2025. This certification authorizes the facility to produce drug substances and enables it to become fully operational. The site is expected to manufacture a portfolio of mRNA vaccines against respiratory viruses, including COVID-19, RSV, and seasonal influenza, starting in 2025, subject to Health Canada approval.
This achievement is part of Moderna's strategic partnership with the Canadian government to support national pandemic readiness and provide onshore manufacturing capabilities. The Laval facility is Moderna's first manufacturing site outside the U.S. to reach this milestone, complementing its existing and planned facilities in the United States, Australia, and the UK.
Moderna (NASDAQ:MRNA) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for an updated formulation of its COVID-19 mRNA vaccine Spikevax. The vaccine targets the SARS-CoV-2 variant JN.1 and is intended for active immunization to prevent COVID-19 in individuals six months of age and older.
Pending European Commission authorization, the updated vaccine will be available for the 2024-2025 vaccination season. The decision is based on manufacturing and preclinical data, along with previous clinical, non-clinical, and real-world evidence. Moderna has already received approval for this vaccine in Japan, Taiwan, and the UK, while a version targeting the KP.2 variant has been approved in the U.S.
Moderna has received authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its updated COVID-19 vaccine targeting the JN.1 variant of SARS-CoV-2. The vaccine, Spikevax® JN.1, will be available through the NHS autumn vaccination program for eligible groups and, for the first time in the UK, can be purchased privately. This approval aligns with recommendations from global health bodies to develop JN.1-targeted vaccines, as the JN.1 subvariants currently dominate in the UK.
The updated vaccine aims to protect those at highest risk of severe COVID-19 illness and reduce strain on the NHS. It will be accessible through high street pharmacies, occupational health providers, and private healthcare companies for those not eligible for the NHS program.
Moderna (NASDAQ:MRNA) has received approval from the Taiwan Food & Drug Administration for an updated formulation of its COVID-19 mRNA vaccine Spikevax. This new version targets the SARS-CoV-2 variant JN.1 and is approved for active immunization against COVID-19 in individuals aged six months and older. The approval aligns with the World Health Organization's April 2024 recommendation for using a monovalent JN.1 lineage in COVID-19 vaccine compositions. Moderna is currently awaiting regulatory decisions on this updated vaccine from agencies worldwide, with outcomes expected in the near future.
Flagship Pioneering and Quotient Therapeutics have announced a collaboration with Pfizer to identify potential novel targets for cardiovascular and renal diseases. This agreement, initiated under the strategic partnership between Flagship Pioneering and Pfizer, leverages Quotient's Somatic Genomics platform to analyze somatic mutations in diseased patient tissue.
The collaboration involves two research programs aimed at discovering and developing transformative therapies. Pioneering Medicines, Flagship's in-house drug discovery unit, will lead the strategic partnership with Pfizer. This initiative represents a significant milestone in the partnership and highlights the potential of collaboration to accelerate therapeutic innovation in addressing cardiovascular and renal diseases, which are leading causes of mortality and morbidity worldwide.
Moderna (NASDAQ:MRNA) is facing a class action lawsuit for alleged violations of securities regulations. The Schall Law Firm has announced a reminder to investors who purchased Moderna securities between January 18, 2023, and June 25, 2024, to join the lawsuit before October 8, 2024.
The lawsuit claims Moderna made false and misleading statements about its mRESVIA (mRNA-1345) product, overstating its effectiveness and commercial prospects. When the truth was revealed, investors reportedly suffered damages.
Shareholders who experienced losses are encouraged to contact the Schall Law Firm to discuss their rights. The class has not yet been certified, and interested parties can choose to participate or remain absent class members.
Moderna's mRNA RSV vaccine, mRESVIA®, has received European Commission approval for adults aged 60 and older. This marks the first mRNA vaccine approved beyond COVID-19 in Europe. The approval is based on the Phase 3 ConquerRSV trial, which showed 83.7% vaccine efficacy against RSV lower respiratory tract disease. With 8.6 months median follow-up, efficacy remained at 63.3%. RSV causes about 160,000 hospital admissions annually in the EU, with 92% in adults 65+. mRESVIA is uniquely offered in a pre-filled syringe for easier administration. The vaccine was previously approved by the FDA in May 2024.
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