Moderna, Inc. - MRNA STOCK NEWS

Moderna (NASDAQ:MRNA) has announced the appointment of Abbas Hussain to its Board of Directors, effective October 2, 2024. Hussain, the former CEO of Vifor Pharma, brings over 35 years of commercial leadership and operating experience in healthcare. His background includes serving as Global President of GSK, Pharmaceuticals and Vaccines, providing significant global vaccine commercialization experience in emerging and mature markets.

Moderna's leadership, including Chairman Noubar Afeyan and CEO Stéphane Bancel, expressed enthusiasm about Hussain's addition to the board, citing his strategic insights and global operational expertise as valuable assets for the company's continued growth and innovation. Hussain's extensive experience is expected to strengthen Moderna's commercial organization and support the launch of innovative products.

Moderna and Cenra Healthcare have announced a joint agreement for the co-promotion of Moderna's mRNA respiratory vaccine portfolio in Taiwan, including the COVID-19 vaccine Spikevax. The agreement, effective until July 31, 2027, involves Moderna manufacturing and distributing the vaccines, while Cenra Healthcare will handle promotion and medical education activities to ensure broad access across Taiwan.

Joyce Lee, General Manager of Moderna in Taiwan, expressed excitement about partnering with Cenra Healthcare, citing their expertise in infectious diseases and respiratory products. Lucas Lin, General Manager of Cenra Healthcare, emphasized their ability to support Taiwan's immunization programs through collaboration with healthcare providers and communities.

The partnership aims to advance public health initiatives in Taiwan, particularly as respiratory diseases continue to pose a global threat. Financial terms of the deal were not disclosed.

Moderna has announced the dosing of the first participant in the Nova 301 Trial, a pivotal Phase 3 clinical trial for its investigational mRNA norovirus vaccine, mRNA-1403. The trial aims to evaluate the efficacy, safety, and immunogenicity of the vaccine in preventing moderate to severe norovirus acute gastroenteritis (AGE) in adults.

The study plans to enroll approximately 25,000 participants globally, with a focus on adults 60 years and older who are at higher risk of severe outcomes. The trial will be conducted in various countries across the Northern Hemisphere, equatorial region, and Southern Hemisphere.

Norovirus is a significant public health concern, causing millions of infections worldwide annually and resulting in approximately 200,000 deaths per year. mRNA-1403 is a trivalent formulation designed to protect against multiple norovirus genotypes by encoding for virus-like particles (VLPs).

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.