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.
Merck (MRK) and Moderna have initiated INTerpath-009, a Phase 3 clinical trial evaluating V940 (mRNA-4157) combined with KEYTRUDA for patients with resectable Stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). The trial targets patients who didn't achieve complete response after neoadjuvant KEYTRUDA plus platinum-based chemotherapy. This marks the third Phase 3 trial for V940, focusing on earlier cancer stages. Patient enrollment has begun in Canada, expanding the companies' collaborative INTerpath clinical program which includes trials for melanoma, lung cancer, cutaneous squamous cell carcinoma, renal cell carcinoma, and urothelial carcinoma.
Moderna (NASDAQ:MRNA) has been named a top employer in the global biopharmaceutical industry by Science and Science Careers' 2024 Top Employers Survey for the tenth consecutive year. The company was recognized for its innovation, employee respect, and social responsibility.
Key 2024 achievements include implementing ChatGPT Enterprise across the organization, establishing a new global headquarters in Cambridge, Massachusetts, and continuing development of a Marlborough manufacturing site. The company also celebrated the second anniversary of its Charitable Foundation and released its third ESG Report.
The Science survey gathered over 6,400 responses from readers worldwide, with 65% from North America, 19% from Europe, and 11% from Asia/Pacific Rim.
Moderna (NASDAQ:MRNA) has announced its plans to report third quarter 2024 financial results on Thursday, November 7, 2024. The company will host a live conference call and webcast at 8:00 a.m. ET to discuss the results and provide a corporate update. Investors can access the live webcast through the 'Events and Presentations' section of Moderna's website. The archived webcast will be available approximately two hours after the conference call and will remain accessible for one year following the event. This announcement serves as a notice to shareholders and interested parties about the upcoming financial disclosure and opportunity to gain insights into Moderna's recent performance and future outlook.
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.
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