Moderna Stock Price, News & Analysis

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.

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.

Moderna (NASDAQ: MRNA) announces its participation in two upcoming virtual investor conferences:

• Bernstein Operational Decisions Conference on November 4, 2021 at 4:30 p.m. ET
• Credit Suisse 30th Annual Healthcare Conference on November 8, 2021 at 1:50 p.m. ET

Live webcasts will be available in the Investors section of Moderna's website and will be archived for at least 30 days post-event. Moderna, a leader in mRNA therapeutics, continues to innovate in vaccine development, notably against COVID-19.

Moderna announced the initiation of the Phase 3 pivotal registration study for mRNA-1647, its cytomegalovirus (CMV) vaccine candidate, marking a significant milestone as it is the second Phase 3 study in the company's history. The CMVictory study aims to enroll around 8,000 participants, primarily women aged 16-40. CMV is the leading infectious cause of birth defects in the U.S., with 1 in 200 babies affected. mRNA-1647 combines six mRNAs targeting CMV proteins and has previously shown promising results in Phase 1 and 2 studies.