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. reports developments in mRNA medicines, including commercial vaccines, investigational respiratory vaccines, oncology programs and rare-disease candidates. News commonly covers regulatory authorizations and agency interactions for products such as Spikevax, mRESVIA, mNEXSPIKE and mCOMBRIAX, as well as clinical data for seasonal influenza, pandemic influenza and cancer immunotherapy programs including intismeran autogene and mRNA-4359.
Company updates also include quarterly financial results, revenue mix, expense actions, strategic partnerships, scientific meeting presentations and intellectual-property matters tied to Moderna's infectious disease portfolio and broader mRNA technology platform.
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.
Moderna (NASDAQ:MRNA) announced that President Stephen Hoge, M.D., will participate in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on September 13, 2022, at 10:00 a.m. ET. A live webcast will be available on the Investors section of Moderna's website, with a replay accessible for at least 30 days afterward. Over the past decade, Moderna has evolved into a leader in mRNA therapeutics, having developed vaccines for various diseases, including COVID-19.
Moderna announced that Health Canada has authorized mRNA-1273.214, the first Omicron-targeting bivalent COVID-19 booster vaccine. Clinical trials show that it produces significantly higher antibody levels against Omicron subvariants than mRNA-1273. The company has an agreement with the Government of Canada for the supply of 12 million doses, with an additional 4.5 million doses ordered. This approval is part of Moderna's efforts to combat the spread of COVID-19 as the cold season approaches.
Moderna announced a positive opinion from the European Medicines Agency's (EMA) committee recommending conditional marketing authorization for its bivalent COVID-19 vaccine, mRNA-1273.214. This vaccine targets the Omicron variant and has shown significantly higher antibody responses compared to the original version. Furthermore, the European Commission is expected to make a decision on its use as a booster for individuals 12 and older. Moderna has also secured approvals in Australia, Switzerland, and the UK, reflecting a strong market presence.