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 (NASDAQ:MRNA) has secured a tender for supplying its mRNA COVID-19 vaccine in the European Union, Norway, and North Macedonia. The agreement allows 17 participating countries to access Moderna's vaccine for up to four years.
The company will provide various vaccine formats, including pre-filled syringes, which are preferred by healthcare providers as they can reduce administration errors and save time, potentially improving vaccination campaign efficiency.
This announcement follows the European Commission's marketing authorization granted in September 2024 for Moderna's updated COVID-19 mRNA vaccine Spikevax, which targets the SARS-CoV-2 variant JN.1. The vaccine is authorized for individuals six months of age and older.
Moderna (NASDAQ:MRNA) has received ongoing support from the U.S. Department of Health and Human Services (HHS) to accelerate the development of mRNA-based pandemic influenza vaccines. The $590 million award, made through the Rapid Response Partnership Vehicle (RRPV) Consortium with BARDA funding, will support late-stage development, licensure of pre-pandemic vaccines, and expansion of clinical studies for up to five additional pandemic influenza subtypes.
The company initiated a Phase 1/2 study in 2023 to evaluate safety and immunogenicity of mRNA-1018, an investigational pandemic influenza vaccine targeting H5 and H7 avian influenza viruses, in adults aged 18 and older. Following positive preliminary data, Moderna plans to advance mRNA-1018 to Phase 3 trials and will present Phase 1/2 results at an upcoming scientific meeting.
Moderna reported 2024 product sales of $3.0-3.1 billion (including $1.7B in US) and ended with approximately $9.5B cash balance. The company projects 2025 revenue of $1.5-2.5B, mainly from Spikevax and mRESVIA sales, with an expected year-end cash balance of $6.0B.
The company plans significant cost reductions: $1.0B in 2025 and additional $0.5B in 2026. Key pipeline updates include FDA review of next-generation COVID-19 vaccine (mRNA-1283) with PDUFA date of May 31, 2025, positive Phase 3 data for flu/COVID combination vaccine, and ongoing trials for CMV and norovirus vaccines. The Phase 3 melanoma trial with individualized neoantigen therapy completed enrollment in 2024.
Carisma Therapeutics (NASDAQ: CARM) announced a strategic restructuring, including discontinuation of CT-0525 development and a 34% workforce reduction. The company will redirect focus to its in vivo macrophage engineering platform for fibrosis, oncology, and autoimmune disease therapies.
Key developments include: plans to nominate a liver fibrosis development candidate in Q1 2025; ongoing collaboration with Moderna on multiple oncology and autoimmune programs; and expected restructuring costs of approximately $2.7 million. Three senior executives, including the CFO, General Counsel, and SVP of Human Resources, will depart by December 31, 2024.
The decision to discontinue the anti-HER2 program was based on competitive landscape assessment and recent developments in anti-HER2 therapies affecting antigen loss/downregulation.
Moderna (MRNA) has announced its upcoming participation in two major investor conferences in December 2024. The company will present at the 7th Annual Evercore ISI HealthCONx Conference on December 4th at 1:20pm ET, followed by the Piper Sandler 36th Annual Healthcare Conference on December 5th at 10:30am ET.
Live webcasts of both presentations will be accessible through the Investors section of Moderna's website under 'Events and Presentations.' Recordings will remain available for at least 30 days after each presentation.
Moderna (NASDAQ:MRNA) has been ranked as the top large employer in BioSpace's 2025 Best Places to Work report for the fourth consecutive year. The recognition highlights the company's reputation and commitment to innovation. Moderna continues to invest in employee development through initiatives like its AI Academy and AI-powered tools. The company was also recently recognized in Science and Science Careers' 2024 Top Employers Survey for the tenth consecutive year. Moderna's focus remains on creating an environment fostering meaningful careers while pursuing its mission of delivering multiple products in the coming years.
Carisma Therapeutics (NASDAQ: CARM) announced positive pre-clinical data for its anti-GPC3 in vivo CAR-M therapy for hepatocellular carcinoma (HCC), developed with Moderna. The therapy demonstrated ability to create CAR-M directly in vivo, reprogramming myeloid cells to target GPC3-expressing cancer cells. Pre-clinical results showed specificity for GPC3 tumor antigen with dose-dependent cytotoxicity against GPC3+ tumor cells. In both syngeneic and humanized tumor models, the therapy significantly reduced tumor burden and suppressed liver metastasis. The treatment was well-tolerated in mouse models, showing promise as an off-the-shelf treatment for GPC3+ solid tumors, including HCC.
Moderna (NASDAQ:MRNA) has received Health Canada approval for mRESVIA, an RSV vaccine for adults aged 60 and older. This marks Moderna's second approved product in Canada and the first mRNA vaccine against RSV. The vaccine, available in a unique pre-filled syringe format, is approved for preventing lower respiratory tract disease caused by RSV. The approval is based on Phase 3 ConquerRSV trial data involving 37,000 adults. Supply is expected in Canada in early 2025. The National Advisory Committee on Immunization recommends the vaccine for people aged 75+ and those 60+ in nursing homes, while community-dwelling adults 60+ can decide individually with their healthcare provider.
Moderna reported Q3 2024 financial results with revenues of $1.9 billion and GAAP net income of $13 million ($0.03 EPS). Product sales reached $1.8 billion, including $1.2 billion in U.S. sales and $0.6 billion internationally. The company reiterates 2024 expected product sales of $3.0-3.5 billion. Cost of sales decreased 77% to $514 million. R&D expenses decreased 2% to $1.1 billion, while SG&A expenses dropped 36% to $281 million. Cash position stands at $9.2 billion. The company initiated Phase 3 trials for norovirus and influenza vaccines, and expanded its Executive Committee.
Carisma Therapeutics (Nasdaq: CARM) announced new pre-clinical data presentation on their anti-GPC3 in vivo CAR-M therapy for hepatocellular carcinoma (HCC) at SITC 2024. The therapy, developed with Moderna, uses lipid nanoparticles to deliver mRNA that reprograms endogenous myeloid cells, creating an off-the-shelf treatment approach for GPC3+ solid tumors.
The data, demonstrating robust anti-tumor activity, will be presented on November 8, 2024, at the SITC Annual Meeting in Houston, Texas. The presentation focuses on targeting Glypican-3, a tumor-associated antigen commonly expressed in HCC. Two posters will be presented, including one on the pre-clinical efficacy of anti-GPC3 CAR-M and another on a Phase 1 study of anti-HER2 CAR therapy.
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