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 received marketing authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for mRESVIA, its RSV vaccine for adults 60 years and older. This marks Moderna's second approved product in the UK.
The vaccine, designed to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV), will be manufactured at the Moderna Innovation and Technology Centre in Oxfordshire. RSV significantly impacts UK elderly adults, causing 175,000 GP appointments, 14,000 hospitalizations, and 8,000 deaths annually in those 65 and older.
The approval is based on the Phase 3 ConquerRSV trial, which involved approximately 37,000 adults aged 60+ across 22 countries. No serious safety concerns were identified during the trial.
Moderna (Nasdaq: MRNA) has announced its upcoming participation in two major investor conferences in March 2025. The company will present at the TD Cowen 45th Annual Health Care Conference on Wednesday, March 5th at 9:10am ET, and at the Barclays 27th Annual Global Healthcare Conference on Tuesday, March 11th at 1:30pm ET.
Investors and interested parties can access live webcasts of both presentations through the "Events and Presentations" section of Moderna's investor website at investors.modernatx.com. For those unable to attend the live events, replays of the webcasts will remain available on the company's website for at least 30 days following each presentation.
YourBio Health and Flagship Pioneering have announced the appointment of Paul Owen as CEO of YourBio Health and CEO-Partner of Flagship Pioneering. Owen brings over 35 years of corporate leadership experience, most recently serving as Board Director and President of Oncodea.
YourBio Health's key product, the Touch-Activated Phlebotomy (TAP®) device, is the first push-button blood collection technology using microneedles for virtually painless blood draws. The technology has been implemented in clinical trials, diagnostic settings, and wellness applications, with millions of blood collections completed since its commercial launch.
The company has established partnerships with biopharmaceutical companies, genetic companies, and academic research hospitals. The announcement also includes concurrent appointments to YourBio's leadership team, adding expertise in medical device product innovation, clinical strategy, and commercialization.
Moderna (MRNA) reported Q4 2024 revenues of $1.0 billion with a GAAP net loss of $(1.1) billion and EPS of $(2.91). Full-year 2024 revenues were $3.2 billion with a net loss of $(3.6) billion and EPS of $(9.28). The company's Q4 Spikevax sales reached $923 million, while mRESVIA sales were $15 million.
For 2025, Moderna expects revenues between $1.5-2.5 billion and projects year-end cash balance of approximately $6 billion. The company has submitted three mRNA products for regulatory approval: next-generation COVID vaccine, RSV vaccine for adults 18-59, and a flu/COVID combination vaccine.
Cost reduction efforts resulted in a 27% decrease compared to 2023, with plans to remove nearly $1 billion in costs by end of 2025. The company maintains a strong cash position of $9.5 billion as of December 31, 2024, though down from $13.3 billion year-over-year.
Moderna (NASDAQ:MRNA) has announced it will host a live conference call and webcast on Friday, February 14, 2025, at 8:00 a.m. ET to present its fourth quarter and full year 2024 financial results, along with a corporate update. The webcast will be available in the "Events and Presentations" section of Moderna's investor website. Following the conference call, an archived version of the webcast will be accessible on the company's website for one year.
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.
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