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 reported strong Q1 2022 results, achieving revenues of $6.1 billion and a net income of $3.7 billion, resulting in a diluted EPS of $8.58. The company reaffirmed its 2022 advance purchase agreements totaling $21 billion and outlined plans for four Phase 3 programs in the second quarter, including COVID booster and flu vaccines. Moderna's pipeline now has 46 programs with 29 in clinical trials, showing robust progress in both preventive and therapeutic mRNA applications.
Moderna (NASDAQ: MRNA) has submitted a variation for conditional marketing authorization to the European Medicines Agency (EMA) for its COVID-19 vaccine, Spikevax, targeting children six months to under six years. This follows the EMA's positive recommendation for use in children aged six years and older. Positive interim results indicated strong antibody responses and a favorable safety profile from the Phase 2/3 KidCOVE study. Efficacy estimates for the younger age group showed 51% effectiveness against Omicron. The company also continues to explore booster doses for pediatric populations.
Moderna plans to establish a state-of-the-art mRNA vaccine manufacturing facility in Quebec, with an annual production capacity of up to 100 million doses. This facility is part of a ten-year strategic partnership with the Government of Canada aimed at enhancing pandemic preparedness. Following the expected certification by Health Canada, the facility will produce vaccines for respiratory viruses, including COVID-19. Construction is set to begin in 2022, with operations anticipated by 2024, creating hundreds of jobs and bolstering Canada's life sciences ecosystem.
Moderna, Inc. (NASDAQ: MRNA) has submitted a request for emergency use authorization (EUA) of its COVID-19 vaccine, mRNA-1273, for children aged 6 months to under 6 years. This submission is based on positive results from the Phase 2/3 KidCOVE study, which showed a robust antibody response and favorable safety profile. Vaccine efficacy was reported at 51% for the 6 months to < 2 years age group and 37% for the 2 years to < 6 years group, similar to adult efficacy. The EUA submission will be finalized next week as Moderna continues to research booster doses for pediatric cohorts.
Moderna has appointed Arpa Garay as the new Chief Commercial Officer, effective May 31, 2022. Ms. Garay brings over 16 years of experience from Merck & Co., where she was Chief Marketing Officer and led significant global marketing strategies. Her extensive background in oncology and digital marketing is expected to bolster Moderna's commercial efforts in mRNA therapeutics. Moderna emphasizes its commitment to innovative therapies, aiming to leverage Ms. Garay's expertise to enhance patient outcomes worldwide.
Moderna's bivalent booster candidate mRNA-1273.211 shows enhanced neutralizing titers against COVID-19 variants, including Omicron. This candidate demonstrated superiority for six months after administration against variants of concern. The tolerability and safety were consistent with the authorized mRNA-1273 booster. Additionally, Moderna is assessing another bivalent booster, mRNA-1273.214, in a Phase 2/3 study, with data expected in Q2 2022. These findings support Moderna's strategy to address ongoing virus mutations and enhance vaccine effectiveness.
Moderna (NASDAQ:MRNA) will host a live conference call on May 4, 2022, at 8:00 a.m. ET to discuss its Q1 2022 financial results and provide a corporate update. Investors can join the call by dialing 866-922-5185 (domestic) or 409-937-8950 (international) with conference ID 2083116. Additionally, a webcast will be available under the Investors section of Moderna's website. Over its decade of existence, Moderna has developed a diverse portfolio of mRNA-based therapeutics and vaccines, including significant contributions to the COVID-19 pandemic response.
Moderna announces the appointment of Jorge Gomez as Chief Financial Officer, effective May 9, 2022. He joins from Dentsply Sirona, where he led the global finance organization. Gomez's experience in multinational healthcare companies and his focus on sustainability aligns with Moderna's vision. The current CFO, David Meline, will retire but assist in the transition. Moderna has evolved into a global commercial entity specializing in mRNA therapeutics and vaccines, following significant advancements in science, technology, and manufacturing.
Moderna (NASDAQ:MRNA) announced the initiation of a Phase 1/2 clinical trial for its seasonal influenza vaccine candidates, mRNA-1020 and mRNA-1030. The study will assess the safety, reactogenicity, and immunogenicity of these vaccines targeting hemagglutinin and neuraminidase antigens. Approximately 560 participants will be enrolled, and the trial aims to produce a vaccine with broader immunity against strains recommended by the WHO, including influenza A and B viruses. Moderna's mRNA platform aims to facilitate rapid vaccine matching with circulating strains.
Moderna and IAVI have announced a collaboration to utilize mRNA technology to address critical global health issues, including HIV, tuberculosis, antimicrobial-resistant pathogens, and COVID-19.
This partnership aims to develop vaccines and antibodies, particularly targeting low-income regions. A notable project is the Phase I clinical trial of an HIV vaccine (IAVI G002), with further trials planned in South Africa and Rwanda.
The collaboration seeks to leverage the rapid production capabilities of mRNA to solve urgent public health challenges.
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