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's seasonal influenza vaccine candidate, mRNA-1010, has entered a Phase 3 trial, marking a significant milestone as the company's first flu vaccine to reach this stage. Approximately 6,000 adults in the Southern Hemisphere will participate in this randomized, observer-blind study aimed at evaluating safety and immunological non-inferiority compared to licensed vaccines. Moderna is advancing its respiratory portfolio, which includes multiple mRNA vaccine candidates, with expectations of commercial launches for three respiratory vaccines in the next two to three years.
Moderna (NASDAQ:MRNA) announced an amendment to its COVID-19 vaccine supply agreement with the European Commission, allowing the delivery of booster doses to be postponed to later in 2022 or early 2023. This includes the potential for updated bivalent vaccine candidates pending approval. Moderna expects approximately $21 billion in advanced purchase agreements for 2022, anticipating higher sales in the latter half of the year compared to the first half. The company is currently evaluating a new booster candidate, mRNA-1273.214, with initial data expected in June.
Moderna (NASDAQ:MRNA) announced its upcoming participation in two major investor conferences: the 2022 Jefferies Healthcare Conference on June 8 at 3:00 p.m. ET and the 43rd Annual Goldman Sachs Global Healthcare Conference on June 14 at 12:20 p.m. ET. Live webcasts will be available on the Moderna investor website, with replays archived for at least 30 days. Moderna has evolved from a research-stage company to a leader in mRNA therapeutics, having developed vaccines and therapeutics for various diseases, including a highly effective COVID-19 vaccine.
Moderna has announced that it will assume the role of marketing authorization holder for its COVID-19 vaccine Spikevax™ in Japan starting August 1, 2022. This transition includes taking over all related activities, such as import, regulatory compliance, development, quality assurance, and commercialization. In a collaborative effort, Takeda will continue to provide distribution support during a transitional phase of the national vaccination campaign. Both companies aim to ensure smooth operational implementation during this handover.
Moderna announces it will take over as the marketing authorization holder for its COVID-19 vaccine, SpikevaxTM, in Japan starting August 1, 2022. This transition from Takeda includes responsibilities for import, local regulations, development, quality assurance, and commercialization. Takeda will continue to provide distribution support during a transitional period. This move aims to strengthen Moderna's commercial organization in Japan as it continues to combat the COVID-19 pandemic.
Moderna (Nasdaq: MRNA) will participate in a fireside chat at the UBS 2022 Global Healthcare Conference on May 24 at 9:15 a.m. ET. A live webcast will be available on the company's investor website, with a replay accessible for 30 days post-event. Moderna, known for its mRNA technology, has evolved from a research company to a leader in developing vaccines and therapeutics across various diseases, including COVID-19, reinforcing its position in the biopharmaceutical sector.
IAVI and Moderna announced a Phase I clinical trial in Rwanda and South Africa to assess the safety and immunogenicity of an mRNA HIV vaccine antigen (mRNA-1644). This trial, known as IAVI G003, follows promising results from a prior study that indicated 97% of participants developed targeted immune responses. The trial aims to enroll 18 healthy, HIV-negative adults who will receive two doses of the vaccine. This initiative is supported by the U.S. government and the Bill & Melinda Gates Foundation, aiming to strengthen scientific capacity in regions heavily impacted by HIV.
Moderna detailed advancements in its mRNA platform during its 5th Annual Science and Technology Day, focusing on innovative delivery methods, including pulmonary applications. The company is collaborating with Vertex to develop treatments for cystic fibrosis via inhalation. Evidence supports the safety of its COVID-19 vaccines for pregnant and breastfeeding women. The firm emphasizes the importance of mRNA stability for product shelf-life, achieving improved manufacturing processes. Moderna's ongoing research aims to optimize clinical applications of mRNA across various diseases.
Moderna, Inc. (NASDAQ:MRNA) announced the immediate departure of its Chief Financial Officer, Jorge Gomez, amidst an ongoing internal investigation at his previous employer, Dentsply Sirona Inc. In light of this, David Meline, the recently retired CFO, will resume his role as CFO while the company searches for a new candidate. Moderna emphasizes that these changes come with risks and uncertainties, and encourages stakeholders to refer to its latest filings for detailed risk factors.
Moderna (NASDAQ:MRNA) will host its in-person Science and Technology Day for analysts and investors on May 17, 2022, at 9:00 a.m. ET in Boston, MA. Key presentations will be made by President Stephen Hoge, Chief Scientific Officer Melissa Moore, and other scientists highlighting advances in mRNA technology.
A live webcast will be available on Moderna's investor website, with a replay accessible for one year. Moderna has transformed significantly over the past decade, developing a diverse portfolio of vaccines and therapeutics, particularly noted for its effective COVID-19 vaccine.
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