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, Inc. (Nasdaq: MRNA) has submitted its COVID-19 vaccine for authorization in adolescents to Health Canada. Following encouraging results from the Phase 2/3 TeenCOVE study, which showed 100% efficacy in nearly 2,500 adolescents, the company plans to seek further approvals from the European Medicines Agency and the U.S. FDA. The vaccine exhibited a well-tolerated safety profile, with no significant concerns identified. Moderna currently holds various emergency authorizations globally, demonstrating its commitment to combat the COVID-19 pandemic.
Moderna, Inc. (Nasdaq: MRNA) has submitted for conditional marketing approval of its COVID-19 vaccine for adolescents with the European Medicines Agency. The Phase 2/3 TeenCOVE study showed 100% efficacy in nearly 2,500 adolescents receiving two doses. The vaccine demonstrated a strong safety profile with mostly mild adverse events. Moderna plans to file for Emergency Use Authorization with the U.S. FDA and has received various authorizations globally. The company is also committed to monitoring long-term protection and safety for participants.
Moderna (Nasdaq: MRNA) announced a supply agreement with the Government of Botswana for its COVID-19 vaccine, aimed at enhancing access to vaccines in Botswana. The Botswana Medicines Regulatory Authority has granted emergency use authorization for the vaccine in adults 18 and older. This agreement complements an existing contract with Gavi for up to 500 million doses globally. The vaccine has proven effective in increasing neutralizing antibodies against COVID-19 variants. Moderna continues to expand its mRNA platform for various therapeutic areas.
Moderna (Nasdaq: MRNA) has signed a long-term agreement with UNICEF to supply up to 34 million doses of its COVID-19 vaccine in Q4 2021 and 466 million doses in 2022. The doses will be provided at the company's lowest tiered price, supporting global vaccine access through the COVAX Facility. CEO Stéphane Bancel emphasized the commitment to combating the pandemic. Additionally, the WHO granted Emergency Use Listing for the vaccine, enhancing its distribution potential.
Moderna (Nasdaq: MRNA) announced a new agreement with Lonza to enhance drug substance manufacturing, enabling the supply of an additional 300 million doses of its updated COVID-19 booster vaccine candidate annually at a 50 µg dose. This builds on previous investments, allowing for a total of 600 million doses per year from EU production. The company is ramping up production capacity in collaboration with multiple partners, targeting completion by year-end 2021 to meet global demand for its vaccines.
Moderna (Nasdaq: MRNA) has entered a partnership with Thermo Fisher Scientific (NYSE: TMO) for sterile manufacturing services for its COVID-19 vaccine. This collaboration will utilize Thermo Fisher's Greenville, NC facility for fill/finish, labeling, and packaging, enabling the production of hundreds of millions of vaccine doses starting Q3 2021. Moderna's Chief Technical Operations and Quality Officer expressed satisfaction in expanding the relationship to enhance manufacturing capabilities. This agreement highlights Moderna's continued efforts to scale vaccine production amidst the ongoing pandemic.
Moderna (Nasdaq: MRNA) has initiated the rolling submission process for a Biologics License Application (BLA) for its mRNA COVID-19 vaccine aimed at individuals 18 and older. The request includes a Priority Review, with data from ongoing Phase 3 studies being submitted periodically. The vaccine is currently authorized under Emergency Use Authorization (EUA) and has administered over 124 million doses in the U.S. since its EUA grant in December 2020. Moderna continues to innovate with variant-specific booster candidates as part of its COVID-19 response.
Moderna (Nasdaq: MRNA) has announced its participation in two upcoming virtual investor conferences. The Jefferies Virtual Healthcare Conference will take place on June 3, 2021, at 10:00 a.m. ET, followed by the Goldman Sachs 42nd Annual Healthcare Conference on June 9, 2021, at 8:00 a.m. ET. Live webcasts of both events will be accessible on the Investors section of Moderna's website, and replays will be available for 30 days post-event. Moderna has evolved significantly in its 10-year history, establishing a strong clinical portfolio and a robust mRNA platform for various diseases.
Moderna, Inc. (Nasdaq: MRNA) held its fourth annual Science Day to showcase developments in mRNA therapeutics and vaccines. The event highlights 24 mRNA programs, with 14 in clinical studies, and focuses on the advancements in mRNA delivery, particularly targeting hematopoietic stem cells, and optimizing mRNA engineering for enhanced protein expression. The company is also leveraging AI to address SARS-CoV-2 variants. These efforts underscore Moderna's continuous commitment to innovation in utilizing mRNA for therapeutic purposes.
Moderna (Nasdaq: MRNA) announced that its Phase 2/3 study of the COVID-19 vaccine (mRNA-1273) in adolescents (ages 12-17) successfully met its primary immunogenicity endpoint. The study, enrolling over 3,700 participants, showed no COVID-19 cases in the vaccine group after two doses, achieving 100% efficacy under adult case definitions. Additionally, a 93% efficacy was noted in seronegative participants using a secondary CDC definition after the first dose. The safety profile was consistent with adult studies, prompting plans to submit findings for global regulatory approval in early June.
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