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 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.
Moderna, Inc. (NASDAQ:MRNA) announced the Government of Canada has opted to purchase an additional 4.5 million doses of its Omicron-containing bivalent vaccine booster candidate. This decision also includes advancing the delivery of 1.5 million doses to 2022 from 2023. Furthermore, an agreement was made to convert six million doses of the COVID-19 vaccine to the bivalent version, pending regulatory approval by Health Canada. The contract underscores Canada's commitment to public health as winter approaches.
Moderna, Inc. (NASDAQ:MRNA) announced the appointment of James Mock as Chief Financial Officer, effective September 6, 2022, succeeding David Meline who will retire but continue as a consultant. CEO Stéphane Bancel praised Mock's experience, highlighting Moderna's growth with four Phase 3 trials and strong financial positioning. Mock previously held the CFO role at PerkinElmer and has significant experience at General Electric. Moderna emphasizes its mRNA platform advancements and diverse clinical portfolio, showcasing its role in addressing COVID-19.
Moderna (NASDAQ:MRNA) announced the conditional authorization by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its Omicron-containing bivalent COVID-19 booster vaccine, mRNA-1273.214. This vaccine has shown significantly higher antibody titers against Omicron variants (BA.1, BA.4, BA.5) compared to its predecessor, mRNA-1273. Clinical trials confirmed that mRNA-1273.214 met all primary endpoints, increasing neutralizing GMT approximately 8-fold above baseline levels. Moderna is working with UK health authorities to make the vaccine available, with further regulatory submissions underway in Australia, Canada, and the EU.
Moderna reported second quarter 2022 revenues of $4.7 billion and a GAAP net income of $2.2 billion, translating to GAAP diluted EPS of $5.24. Total revenues for the first half of the year reached $10.8 billion. The company reiterated advance purchase agreements for approximately $21 billion in expected 2022 deliveries and announced a new $3 billion share repurchase plan. Moderna has four vaccines in Phase 3 trials and expects pivotal data for additional studies by year-end 2022.
Moderna has secured a new contract with the U.S. government worth up to $1.74 billion for 66 million doses of its bivalent COVID-19 vaccine booster, mRNA-1273.222. This agreement includes options for the government to acquire up to 300 million doses. The vaccine targets the Omicron BA.4/5 variants and is being developed in conjunction with FDA guidelines. Federal funding comes from various health departments and entities. The contract further supports Moderna's ongoing collaboration with the government in addressing COVID-19.
Moderna (NASDAQ:MRNA) announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending a booster dose of Spikevax for adolescents aged 12-17, to be administered at 50 µg at least three months after the primary series. This recommendation aims to enhance protection against COVID-19 and variants such as Omicron. The decision is based on comprehensive safety data and is pending final authorization from the European Commission.
Moderna, Inc. (NASDAQ:MRNA) has received provisional approval from Australia's Therapeutic Goods Administration (TGA) for its mRNA COVID-19 vaccine, Spikevax, for children aged 6 months to five years. This approval allows vaccination in a previously ineligible age group, enhancing public health measures against COVID-19. The decision follows positive interim results from the Phase 2/3 KidCOVE study, showing robust neutralizing antibody responses and favorable safety profiles. Moderna aims to collaborate with the Australian government for effective implementation of the vaccination program.
Moderna, Inc. (NASDAQ:MRNA) announced that Health Canada has approved the use of its mRNA COVID-19 vaccine, SPIKEVAX, for children aged 6 months to 5 years. This two-dose series, with each dose at 25 µg, is completed over one month, similar to adults' vaccination schedules. Positive interim results from the KidCOVE study indicated that antibody responses in young children were comparable to adults, demonstrating effective vaccine safety and efficacy against the Omicron variant. This marks a crucial step in vaccinating a previously unprotected age group.