Moderna, Inc. reports developments in mRNA medicines, including commercial vaccines, investigational respiratory vaccines, oncology programs and rare-disease candidates. News commonly covers regulatory authorizations and agency interactions for products such as Spikevax, mRESVIA, mNEXSPIKE and mCOMBRIAX, as well as clinical data for seasonal influenza, pandemic influenza and cancer immunotherapy programs including intismeran autogene and mRNA-4359.
Company updates also include quarterly financial results, revenue mix, expense actions, strategic partnerships, scientific meeting presentations and intellectual-property matters tied to Moderna's infectious disease portfolio and broader mRNA technology platform.
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.
Moderna (NASDAQ:MRNA) has received approval from Japan's Ministry of Health, Labour and Welfare for an updated COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant JN.1. This aligns with recommendations from a Japanese health ministry panel and the WHO for the 2024/2025 national immunization program. The program will offer vaccination to individuals aged 65 and older, as well as qualifying individuals aged 60-64.
Japan, with about 30% of its population aged 65 and above, aims to reduce the disease burden and pressure on the health system. Moderna has also entered an agreement with Mitsubishi Tanabe Pharma for co-promotion of its mRNA respiratory vaccine portfolio in Japan.