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 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.
Moderna, Inc. (MRNA) has received emergency use authorization from the FDA for its new bivalent COVID-19 booster vaccine, mRNA-1273.222, targeting the Omicron BA.4/.5 variants. This booster is available for adults over 18 who have previously received COVID-19 vaccinations. The 50 µg booster dose includes mRNA for both the original virus strain and the BA.4/.5 variants. The vaccine aims to enhance public health protection against the ongoing pandemic, especially with increasing indoor gatherings. Doses are expected to be available nationwide soon.
Australia has granted provisional approval for Moderna's next-generation bivalent COVID-19 vaccine, mRNA-1273.214, designed to combat the Omicron variant. The vaccine has shown significantly higher antibody responses against various strains, including Omicron BA.1 and BA.4/5. Moderna plans to supply this vaccine in Australia by September 2022. The approval underscores Australia's leadership in COVID-19 response and follows successful clinical trials that demonstrated superior immunity compared to prior vaccines. This development marks a vital step in enhancing public health safety for Australians.
Moderna (Nasdaq:MRNA) will host its R&D Day on September 8, 2022, at 9:00 a.m. ET, available both in-person and virtually. The event will feature key presentations from CEO Stéphane Bancel and President Stephen Hoge, M.D., along with the Moderna clinical team. Interested parties can access a live webcast through the Investors section of Moderna's website, with a replay available for one year post-event. Moderna, a leader in mRNA therapeutics, has a diverse clinical portfolio and significant collaborations impacting vaccine development.
Switzerland has approved Moderna's next-generation bivalent COVID-19 booster vaccine, mRNA-1273.214, for individuals aged 18 and older. This vaccine has shown significantly higher antibody responses against Omicron variants compared to the original Spikevax. Clinical trial data confirmed that mRNA-1273.214 increased neutralizing antibody titers approximately 8-fold above baseline levels. Moderna plans to supply the vaccine in Switzerland in early September and has received similar approvals in the UK and other regions.
Moderna is pursuing patent infringement lawsuits against Pfizer and BioNTech in the U.S. and Germany over their COVID-19 vaccine Comirnaty, claiming it unlawfully uses Moderna's patented mRNA technology developed between 2010 and 2016. Moderna is not seeking removal of Comirnaty from the market, nor damages for sales to 92 low- and middle-income countries under GAVI COVAX. The lawsuits aim to protect Moderna's innovations while expecting compensation from Pfizer and BioNTech for usage outside these regions.
Moderna, Inc. (MRNA) has completed its submission to the U.S. FDA for emergency use authorization of its bivalent COVID-19 booster, mRNA-1273.222, targeting the Omicron BA.4/BA.5 strains. The booster aims to provide superior protection against COVID-19 compared to existing vaccines. Based on encouraging clinical trial data, including meeting all primary endpoints, Moderna anticipates being ready to distribute doses in September if approved. The company emphasizes its commitment to rapid vaccine development through its mRNA platform, which has already successfully facilitated the deployment of effective COVID-19 vaccines.