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 biotechnology company focused on mRNA medicines, with multiple approved vaccines and a broad clinical pipeline. The MRNA news page on Stock Titan aggregates company announcements, investor updates and regulatory developments so readers can follow how Moderna’s strategy and pipeline progress translate into real-world events.
Investors and observers can use this feed to track commercial updates on products such as Spikevax, mRESVIA and mNEXSPIKE, along with developments in late-stage respiratory programs like the seasonal influenza vaccine mRNA-1010, the flu/COVID combination vaccine mRNA-1083 and the Norovirus vaccine candidate mRNA-1403. News items often cover regulatory submissions and opinions from agencies including the U.S. Food and Drug Administration, the European Medicines Agency, Health Canada and others.
The page also surfaces pipeline and clinical trial news in oncology and rare diseases, including updates on mRNA-4157 (intismeran autogene), mRNA-4359, mRNA-3927 for propionic acidemia and mRNA-3705 for methylmalonic acidemia. Announcements related to partnerships, such as CEPI’s funding commitment for the H5 pandemic influenza vaccine candidate mRNA-1018, appear here as well.
In addition, the MRNA news feed includes financial results, guidance and capital structure updates, such as quarterly earnings releases, multi-year financial frameworks and information on facilities like the $1.5 billion credit agreement. Corporate items, including participation in healthcare conferences, Analyst Day presentations and shareholder meeting outcomes, are also reflected.
By reviewing this consolidated news stream, readers can see how Moderna’s respiratory vaccine franchise, oncology and rare disease programs, manufacturing expansion and financing decisions evolve over time, all based on the company’s own disclosures and related announcements.
Moderna (NASDAQ:MRNA) and Merck (NYSE:MRK) announced that their investigational personalized mRNA cancer vaccine, mRNA-4157/V940, in combination with KEYTRUDA, has received PRIME scheme designation from the European Medicines Agency (EMA). This designation follows positive data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial for treating high-risk stage III/IV melanoma after complete surgical resection. The first detailed results will be presented at the American Association for Cancer Research (AACR) from April 14-19. With a high unmet need for melanoma therapies, this designation aims to accelerate access to effective treatments for patients. Further, the FDA has granted Breakthrough Therapy Designation for the same combination, alongside plans for a Phase 3 study in 2023.
Moderna and the Government of Kenya have finalized an agreement to build an mRNA manufacturing facility in Kenya, marking the company's first such facility in Africa. The new facility aims to produce up to 500 million doses of vaccines annually, enhancing health security for Kenya and the broader African continent. This investment aligns with Moderna's global public health strategy to address unmet health needs, including infectious diseases like HIV and Ebola. The facility will operate under a Special Economic Zone status to facilitate economic growth and attract foreign investment.
Gandeeva Therapeutics has announced a research collaboration with Moderna Inc. (NASDAQ: MRNA) to explore applications of its cryogenic electron microscopy (cryo-EM) technology. The collaboration aims to validate Gandeeva's unique platform for a specific Moderna target, details of which remain undisclosed. The partnership reflects Gandeeva's drive to develop innovative therapeutics by integrating AI and structural biology to target challenging protein interactions. Research payments will be made by Moderna as part of the agreement, facilitating the advancement of Gandeeva's preclinical oncology pipeline.
Moderna, Inc. (NASDAQ:MRNA) will host its Vaccines Day for analysts and investors on April 11, 2023, at 8:00 a.m. ET. The event aims to showcase presentations on its mRNA vaccines and essential vaccine development insights from management and key opinion leaders. The presentation will be available via a live webcast and can be accessed later on Moderna's website. Over the past decade, Moderna has evolved from a research-stage entity to a leading biotechnology company, recognized for its groundbreaking mRNA therapeutics and vaccines, including significant contributions to COVID-19 vaccination efforts.
Moderna (Nasdaq:MRNA) has announced a strategic collaboration with Generation Bio to develop novel nucleic acid therapeutics. This partnership will leverage Generation Bio's proprietary stealth cell-targeted lipid nanoparticle (ctLNP) delivery system and closed-ended DNA (ceDNA) technology for two immune cell and two liver programs, with an option for a third program. Moderna will provide a $40 million upfront cash payment, a $36 million equity investment, and will fund all research and development activities. The collaboration aims to expand the therapeutic pipeline, targeting immune cells and the liver for gene therapies, potentially benefiting numerous patients.
BenevolentAI, a clinical-stage AI-enabled drug discovery company, has appointed Marcello Damiani to its Board of Directors, with confirmation pending at the Annual General Meeting scheduled for 4 May 2023. Damiani, a former executive at Moderna (NASDAQ: MRNA), brings over 25 years of experience in technology and biotech. His leadership is expected to enhance the board's diversity and support BenevolentAI's growth strategy. The company continues to focus on leveraging AI for drug development, collaborating with major institutions to advance its innovative platforms.
Moderna, Inc. (NASDAQ:MRNA) announced the acceptance of two abstracts concerning the investigational mRNA personalized cancer vaccine, mRNA-4157/V940, for presentation at the 2023 AACR Annual Meeting from April 14-19 in Orlando, FL. The first abstract, presented by Dr. Jeffrey S. Weber, addresses the efficacy and safety of mRNA-4157 combined with pembrolizumab for high-risk melanoma. The second, by Dr. Ryan J. Sullivan, evaluates minimal residual disease as a biomarker in treated patients. Moderna and Merck plan to initiate a Phase 3 study in 2023, expanding to other tumor types like non-small cell lung cancer.
Moderna (NASDAQ:MRNA) is expanding its U.S. presence with new offices in South San Francisco and Seattle, complementing existing locations in the U.S. and a global presence in 17 countries.
In 2023, the company plans to hire approximately 2,000 new employees as it invests in technology solutions and aims to embed AI in its operations. Key developments in its pipeline include the personalized cancer vaccine candidate and the RSV vaccine, both receiving Breakthrough Therapy Designation from the FDA.
Moderna currently has 48 mRNA programs under development, with 38 in active clinical trials, reinforcing its commitment to mRNA therapeutics.
Moderna, Inc. (NASDAQ:MRNA) will participate in a fireside chat at Cowen's 43rd Annual Health Care Conference on March 6, 2023, at 9:10 a.m. ET. A live webcast will be available in the Investors section of Moderna's website, with a replay accessible for at least 30 days post-event.
Since its inception over a decade ago, Moderna has advanced mRNA therapeutics and vaccines, notably developing effective COVID vaccines. The company has expanded its clinical portfolio across multiple disease areas, underpinned by strategic alliances and robust manufacturing capabilities. Moderna has been recognized as a leading biopharmaceutical employer by Science for eight consecutive years.
Moderna reported fourth quarter 2022 revenues of $5.1 billion and full-year revenues of $19.3 billion. The company achieved a GAAP net income of $1.5 billion for Q4, with a corresponding diluted EPS of $3.61, marking a year-over-year decline. Among its notable developments, Moderna expects approximately $5 billion in contracted COVID-19 sales for 2023, alongside advancements in its mRNA-1345 RSV vaccine, which received FDA Breakthrough Therapy Designation. The company plans to elevate R&D investments to $4.5 billion in 2023 while announcing corporate leadership changes.