Moderna Stock Price, News & Analysis

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.

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.