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 reported a robust Q3 2021 with total revenue of $5.0 billion, a significant increase from $157 million in Q3 2020. The net income surged to $3.3 billion, resulting in diluted EPS of $7.70. Key developments include the U.S. FDA granting Priority Review for the COVID-19 vaccine BLA and promising interim efficacy results from the KidCOVE study showing 100% effectiveness after the first dose in kids aged 6-12. Moderna also initiated a Phase 3 study for a CMV vaccine and unveiled plans for inhaled pulmonary therapeutics with Vertex.
Moderna (NASDAQ:MRNA) announces a strategic collaboration with Metagenomi focused on in vivo gene editing therapeutics. The multi-year partnership, covering undisclosed disease targets, includes an upfront cash payment, equity investment, and research funding, with potential milestone and royalty payments. The collaboration aims to leverage Metagenomi's advanced gene editing systems and Moderna's mRNA and LNP technologies to develop transformative therapies for genetic diseases. This partnership strengthens Moderna's portfolio in genomic medicine.
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Moderna, Inc. (Nasdaq: MRNA) announced that the FDA requires more time to assess the company's EUA request for the COVID-19 vaccine (mRNA-1273) for adolescents aged 12 to 17. The FDA's review may extend beyond January 2022 due to concerns about myocarditis risk following vaccination. Despite over 1.5 million adolescents vaccinated, Moderna's safety data does not indicate an increased myocarditis risk in this group. Additionally, the filing for pediatric EUA (6-11 years) will be delayed until the FDA completes its review.
Moderna has announced an agreement with Gavi to supply 116.5 million doses of its COVID-19 vaccine in Q2 2022, increasing from a previous 60 million doses. This agreement includes options for an additional 233 million doses under the COVAX Facility, potentially totaling 500 million doses for 2021-2022. All doses will be offered at the lowest tiered price, supporting global access initiatives. The partnership aims to provide vaccines to 92 low- and middle-income countries.
Moderna (NASDAQ: MRNA) announces its participation in two upcoming virtual investor conferences:
- Bernstein Operational Decisions Conference on November 4, 2021 at 4:30 p.m. ET
- Credit Suisse 30th Annual Healthcare Conference on November 8, 2021 at 1:50 p.m. ET
Live webcasts will be available in the Investors section of Moderna's website and will be archived for at least 30 days post-event. Moderna, a leader in mRNA therapeutics, continues to innovate in vaccine development, notably against COVID-19.
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Moderna announced the initiation of the Phase 3 pivotal registration study for mRNA-1647, its cytomegalovirus (CMV) vaccine candidate, marking a significant milestone as it is the second Phase 3 study in the company's history. The CMVictory study aims to enroll around 8,000 participants, primarily women aged 16-40. CMV is the leading infectious cause of birth defects in the U.S., with 1 in 200 babies affected. mRNA-1647 combines six mRNAs targeting CMV proteins and has previously shown promising results in Phase 1 and 2 studies.
Moderna has received authorization from Swissmedic for a 50 µg booster dose of its COVID-19 vaccine, Spikevax, for vulnerable individuals aged 12 and older, at least six months after the primary series. Additionally, a third dose at 100 µg is approved for immunocompromised persons at least 28 days post-second dose. The approvals are backed by clinical data indicating a strong immune response. CEO Stéphane Bancel expressed gratitude for the support, emphasizing the significance of mRNA vaccines against evolving COVID-19 variants.
Moderna has signed a new Memorandum of Understanding (MoU) to provide up to 110 million doses of its COVID-19 vaccine to the African Union. Initial deliveries include 15 million doses in Q4 2021 and 35 million doses in Q1 2022. Moderna will supply these doses at its lowest tiered price as part of its global access commitments. The company is also planning to establish a mRNA vaccine manufacturing facility in Africa by 2023, aiming to produce 500 million doses annually, showcasing its commitment to improve vaccine access in low-income countries.
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