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 has received a positive opinion from the European Medicines Agency's CHMP to include its COVID-19 vaccine, Spikevax (mRNA-1273), for children aged 6 months to 5 years. This follows positive interim results from the KidCOVE study, which showed robust antibody responses and safety for this age group. The two-dose series, comparable in efficacy to adults, takes one month to complete. The authorization decision by the European Commission is forthcoming, expanding vaccination options for young children, particularly at risk from COVID-19.
Moderna, Inc. (NASDAQ:MRNA) has announced positive clinical results for its bivalent booster, mRNA-1273.214, showing a durable immune response against COVID-19 variants. New data revealed that 90 days post-administration, the booster generated superior neutralizing antibody responses against Omicron BA.1 compared to its previous version. The booster also effectively targets variants BA.4/BA.5 and BA.2.75. Safety profiles remained consistent with earlier doses, with no new safety concerns reported. Comprehensive data will be presented at ID Week on October 20, 2022.
Moderna and Gavi have mutually decided to cancel pending orders for COVID-19 vaccines for 2022. Instead, they will establish a new agreement allowing Gavi to procure up to 100 million doses of updated variant-specific vaccines in 2023 at Moderna's lowest price tier. Moderna has delivered nearly 70 million doses to low- and middle-income countries through Gavi's COVAX initiative, also facilitating over 100 million donations. This agreement aims to ensure equitable access to COVID-19 vaccines for vulnerable populations.
Moderna, Inc. (NASDAQ:MRNA) has scheduled a live conference call for November 3, 2022, at 8:00 a.m. ET to discuss its Q3 2022 financial results and provide a corporate update. The call will be accessible via telephone with prior registration, and a live webcast will also be available on their website. Moderna has evolved from a research-stage company into a leader in mRNA therapeutics and vaccines, focusing on various diseases, including COVID-19. The archived webcast will be accessible for a year post-call.
Moderna, Inc. (NASDAQ:MRNA) has received emergency use authorization from the FDA for its bivalent COVID-19 booster vaccine, mRNA-1273.222, targeting the BA.4/BA.5 Omicron variant. This authorization is applicable for children and adolescents aged 6 to 17. The vaccine consists of two doses: 25 µg for ages 6-11 and 50 µg for ages 12-17. With this approval, Moderna expands its booster options for younger populations as the winter season approaches. The company is also finalizing an EUA application for kids aged 6 months to 5 years, expected to be submitted later this year.
Moderna and Merck announced Merck's exercise of its option to jointly develop personalized cancer vaccine mRNA-4157/V940. This vaccine is being tested in a Phase 2 trial alongside KEYTRUDA for high-risk melanoma patients, with data expected by the end of 2022. Merck will pay Moderna $250 million for this collaboration, which began in 2016. The trial, involving 157 patients, aims to assess the vaccine's effectiveness compared to KEYTRUDA alone, focusing on recurrence-free survival.
Moderna, Inc. (NASDAQ:MRNA) announces strategic leadership changes to bolster its upcoming product launches. Effective January 1, 2023, Juan Andres transitions to President of Strategic Partnerships and Enterprise Expansion, continuing on the Executive Committee. Dr. Jerh Collins joins as Chief Technical Operations and Quality Officer on October 3, 2022, succeeding Andres. Collins brings nearly 30 years of experience in pharmaceutical manufacturing, aiming to expand Moderna's production capabilities. These appointments reflect Moderna's commitment to scaling operations and enhancing its diverse mRNA therapeutics portfolio.
Moderna (NASDAQ: MRNA) has filed for the evaluation of its next-generation bivalent COVID-19 vaccine, mRNA-1273.222, targeting the Omicron BA.4/BA.5 subvariants in adults aged 12 and older. This follows the recent approval of its BA.1 targeting vaccine by the European Medicines Agency (EMA). The filing is backed by preclinical and clinical trial data, and Moderna's Omicron-targeting boosters are currently authorized in various regions, including the U.S., Canada, and Europe. CEO Stépahne Bancel emphasized the importance of these vaccines as winter approaches.
Moderna (NASDAQ:MRNA) announced the approval of its Omicron-targeting bivalent COVID-19 booster, mRNA-1273.214, by Japan's Ministry of Health, Labour and Welfare. This new booster combines mRNA-1273 and a candidate for the Omicron BA.1 variant. The approval is based on Phase 2/3 trial data showing significantly higher antibody responses against Omicron subvariants compared to the previously authorized booster. Moderna is set to supply the vaccine in Japan by September, with distribution support from Takeda Pharmaceutical.
Moderna presented interim data on its mRNA programs at the 2022 R&D Day, focusing on encouraging results from Phase 1/2 trials for mRNA-3927 (Propionic Acidemia) and mRNA-3745 (Glycogen Storage Disease 1a). Both candidates were well-tolerated with signs of potential clinical benefits. New candidate mRNA-3139 for Ornithine Transcarbamylase deficiency was also announced. Additionally, robust enrollment in Phase 3 trials for RSV vaccine (mRNA-1345) and flu vaccine (mRNA-1010) was reported, with plans for accelerated approvals in 2023.