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) announced that its Omicron-targeting bivalent COVID-19 booster, mRNA-1273.222, received approval from Japan's Ministry of Health, Labour and Welfare. This booster is designed for adults aged 18 and older and contains mRNA-1273 and a variant-targeting component. The approval aims to provide a stronger immune response against circulating Omicron subvariants in Japan. The Phase 2/3 trial for the vaccine is ongoing, supported by Takeda Pharmaceutical Co. for distribution during Japan's national vaccination campaign.
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Moderna (Nasdaq: MRNA) has received a positive opinion from the European Medicines Agency's CHMP recommending conditional marketing authorization for mRNA-1273.222 (Spikevax bivalent Original/Omicron BA.4-5) as a booster for individuals aged 12 and older. This follows the recent approval of the mRNA-1273.214 vaccine targeting Omicron BA.1. The bivalent vaccine mRNA-1273.222 aims to provide protection against Omicron subvariants as winter approaches. Initial data from a Phase 2/3 trial is expected later this year, enhancing Moderna's position in the COVID-19 vaccine market.
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.