Moderna Stock Price, News & Analysis

Moderna has received authorization from Health Canada for a booster dose of its COVID-19 vaccine, SPIKEVAX, at a 50 µg dose for individuals aged 18 and older, to be given at least six months after the primary series.

The decision was based on clinical data indicating significant increases in neutralizing antibody levels post-booster, including in adults over 65. The safety profile aligns with previous doses, establishing confidence in the vaccine's continued efficacy against variants.

Moderna announced positive results from the Phase 2 EPICCURE study assessing AZD8601, an mRNA therapeutic for patients undergoing coronary artery bypass grafting (CABG). The study met its primary endpoint of safety and tolerability with 11 participants, revealing numerical improvements in heart failure endpoints, including increased left ventricular ejection fraction (LVEF). All treated patients maintained healthy NT-proBNP levels at follow-up. This data reinforces the potential of AZD8601 for advancing treatment options in heart failure and warrants further exploration in larger studies.

Moderna (MRNA) announced interim data from a Phase 1 study of mRNA-2752 for treating solid tumors and lymphomas, demonstrating tolerability at all doses tested. The combination therapy with durvalumab (IMFINZI®) showed encouraging anti-tumor activity, with a recommended dose for expansion set at 8mg. Presenting at the Society for Immunotherapy of Cancer's Annual Meeting, the study indicated immunomodulation effects, including increased T cell activation. Ongoing trials continue for various cancers, showcasing the potential of Moderna’s innovative mRNA platform in oncology.

Moderna (Nasdaq: MRNA) has submitted a variation for conditional marketing authorization of its COVID-19 vaccine (mRNA-1273) for children aged 6 to 11 years to the European Medicines Agency (EMA). This marks Moderna's first submission for this age group. The ongoing Phase 2/3 KidCOVE study has shown vaccine efficacy of 100% for symptomatic COVID-19 and 80% for all SARS-CoV-2 infections after the first dose. The company plans to share data with various regulatory agencies globally to protect younger populations.

Moderna reported a robust Q3 2021 with total revenue of $5.0 billion, a significant increase from $157 million in Q3 2020. The net income surged to $3.3 billion, resulting in diluted EPS of $7.70. Key developments include the U.S. FDA granting Priority Review for the COVID-19 vaccine BLA and promising interim efficacy results from the KidCOVE study showing 100% effectiveness after the first dose in kids aged 6-12. Moderna also initiated a Phase 3 study for a CMV vaccine and unveiled plans for inhaled pulmonary therapeutics with Vertex.

Moderna (NASDAQ:MRNA) announces a strategic collaboration with Metagenomi focused on in vivo gene editing therapeutics. The multi-year partnership, covering undisclosed disease targets, includes an upfront cash payment, equity investment, and research funding, with potential milestone and royalty payments. The collaboration aims to leverage Metagenomi's advanced gene editing systems and Moderna's mRNA and LNP technologies to develop transformative therapies for genetic diseases. This partnership strengthens Moderna's portfolio in genomic medicine.

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Moderna, Inc. (Nasdaq: MRNA) announced that the FDA requires more time to assess the company's EUA request for the COVID-19 vaccine (mRNA-1273) for adolescents aged 12 to 17. The FDA's review may extend beyond January 2022 due to concerns about myocarditis risk following vaccination. Despite over 1.5 million adolescents vaccinated, Moderna's safety data does not indicate an increased myocarditis risk in this group. Additionally, the filing for pediatric EUA (6-11 years) will be delayed until the FDA completes its review.

Moderna has announced an agreement with Gavi to supply 116.5 million doses of its COVID-19 vaccine in Q2 2022, increasing from a previous 60 million doses. This agreement includes options for an additional 233 million doses under the COVAX Facility, potentially totaling 500 million doses for 2021-2022. All doses will be offered at the lowest tiered price, supporting global access initiatives. The partnership aims to provide vaccines to 92 low- and middle-income countries.