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.
Personalis, Inc. (PSNL) and Moderna, Inc. (MRNA) have signed a new agreement to utilize the Personalis NeXT Platform for clinical studies involving the investigational personalized cancer vaccine, mRNA-4157/V940. This platform previously supported the Phase 2b clinical study, sequencing genomic data from patient tumor samples to identify mutations that may prompt tailored antitumor responses. Chris Hall from Personalis expressed excitement about continuing their collaboration with Moderna, emphasizing the aim to advance individualized cancer treatments.
Moderna, Inc. (NASDAQ:MRNA) will host a live conference call and webcast on February 23, 2023, at 8:00 a.m. ET to report its fourth quarter and full year 2022 financial results.
The call will provide a corporate update, and a webcast will be available in the Investors section of the Moderna website.
Since its inception, Moderna has evolved from a research-stage company to a major biotechnology enterprise with a diverse clinical portfolio, strong manufacturing capabilities, and significant mRNA technology advancements.
Moderna, Inc. (NASDAQ:MRNA) announced that its investigational mRNA vaccine candidate, mRNA-1345, for respiratory syncytial virus (RSV) has received Breakthrough Therapy Designation from the FDA. This designation is granted based on the positive topline data showing an efficacy of 83.7% against RSV lower respiratory tract disease in adults aged 60 and older, as observed in the ConquerRSV Phase 3 trial. The vaccine was well tolerated, with mild side effects reported. Moderna plans to submit a licensing application in the first half of 2023, aiming to address the significant health impact of RSV in older adults.
Moderna's mRNA-1345 has shown a vaccine efficacy of 83.7% against RSV lower respiratory tract disease in adults over 60, based on results from the Phase 3 ConquerRSV trial with 37,000 participants across 22 countries. The Data and Safety Monitoring Board (DSMB) found no safety concerns, indicating the vaccine was well-tolerated. Moderna plans to seek regulatory approval in the first half of 2023. This marks a significant step in addressing the public health burden of RSV, which significantly affects older adults, leading to thousands of hospitalizations each year. Further detailed results are expected to be presented at an upcoming conference.
Moderna reported unaudited COVID-19 vaccine sales of approximately $18.4 billion for 2022, expecting a minimum of $5.0 billion in 2023 from confirmed contracts. The company has 48 programs in development, including 36 in clinical trials, and plans to increase R&D investment to $4.5 billion for 2023. Key updates include advancing RSV and flu vaccine trials, a promising cancer treatment in collaboration with Merck, and ongoing studies for rare diseases, including propionic acidemia. Moderna's strong cash position exceeds $18 billion.
Moderna and CytomX have announced a collaboration to develop mRNA-based conditionally activated therapies. CytomX will receive an upfront payment of $35 million, including $5 million in research funding, and could earn up to $1.2 billion in milestone payments. This partnership aims to leverage Moderna's mRNA technology and CytomX's Probody platform to create innovative therapeutics for oncology and beyond. Moderna will lead clinical development, while CytomX retains rights to royalties on net sales of commercialized products.
Moderna, Inc. (NASDAQ:MRNA) has announced its acquisition of OriCiro Genomics K.K. for $85 million. This strategic move aims to enhance Moderna's capabilities in mRNA therapeutics by integrating OriCiro's advanced cell-free DNA synthesis technologies. CEO Stéphane Bancel highlighted that the acquisition will significantly bolster their manufacturing processes and R&D efforts. OriCiro's leadership expressed confidence in the synergy between both companies, which is expected to accelerate the development of innovative therapeutics. The acquisition is viewed as a pivotal step in expanding Moderna's technological portfolio.
Moderna, Inc. (NASDAQ:MRNA) will have CEO Stéphane Bancel present its mRNA pipeline updates at the 41st annual J.P. Morgan Healthcare Conference on January 9, 2023, at 5:15 p.m. ET. Attendees can watch the live webcast on Moderna's investors website, where a recording will also be available for 30 days post-event. Founded a decade ago, Moderna has shifted from a research-focused entity to a leading biotechnology firm with a diverse portfolio in therapeutics and vaccines, including significant contributions to COVID-19 vaccine development.
Moderna has finalized a strategic partnership with the UK government to establish a cutting-edge mRNA research, development, and manufacturing facility, enhancing UK capabilities for pandemic response. This ten-year collaboration aims to make domestically manufactured mRNA respiratory vaccines available, contingent upon regulatory approval. Construction of the Moderna Innovation and Technology Centre is expected to begin in early 2023, with operations starting by 2025. The facility will support the UK's 100 Days Mission to better manage future pandemics.
Moderna, Inc (NASDAQ:MRNA) announced the appointment of Chantal Friebertshäuser as Senior Vice President, Commercial for Europe, the Middle East, and Canada, effective January 1, 2023. With over 15 years of experience from Merck Sharp & Dohme, where she held various leadership roles, Friebertshäuser is expected to enhance Moderna's commercial efforts in these regions. She brings a strong background in global market access and commercial strategy, aligning with Moderna's mission to expand its mRNA platform across diverse therapeutic areas.
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