Moderna Stock Price, News & Analysis

Moderna has received a positive opinion from the EMA's CHMP to expand the conditional marketing authorization for its COVID-19 vaccine, Spikevax, to include children aged 6-11. This follows a successful Phase 2/3 study involving over 4,000 children, demonstrating non-inferior antibody responses compared to 18-25 year-olds. The European Commission will decide on the authorization. Additionally, the EMA updated the recommendation for booster doses, now allowing a booster after three months instead of six, and heterologous booster combinations.

Moderna reported remarkable Q4 2021 revenues of $7.2 billion, with a net income of $4.9 billion and diluted EPS of $11.29. For the full year, revenue reached $18.5 billion, significantly up from $803 million in 2020, driven mainly by COVID-19 vaccine sales. The company secured $19 billion in advance purchase agreements for 2022 and announced a $3 billion share repurchase plan. Moderna also received FDA approval for its Spikevax vaccine and is progressing with 44 programs in its mRNA pipeline.

Moderna and Thermo Fisher Scientific have entered a 15-year strategic collaboration agreement for large-scale manufacturing of mRNA vaccines, including Spikevax®, in the U.S. This partnership aims to enhance manufacturing capacity and efficiency for Moderna's investigational mRNA medicines. Thermo Fisher will provide dedicated aseptic fill-finish services, packaging, and inspection to support Moderna's ongoing development efforts. The collaboration builds on their existing relationship that has successfully supported Moderna's COVID-19 vaccine production.

Moderna, Inc. (NASDAQ:MRNA) has signed a distribution agreement with Adium Pharma S.A., enhancing its COVID-19 vaccine access across 18 Latin American countries, including Brazil and Mexico. This accords with Moderna's strategy to expand its commercial presence in 2022, targeting ten additional markets, notably in Asia-Pacific and Europe. Moderna's COVID-19 vaccine has been approved in over 70 markets, with 807 million doses shipped globally in 2021. Through GAVI, it aims to supply 650 million doses to 92 low- and middle-income countries.

Moderna has received endorsement from the independent Data and Safety Monitoring Board to proceed with the Phase 3 clinical study of its RSV vaccine candidate, mRNA-1345, for adults aged 60 and older.

This decision was based on positive preliminary Phase 2 safety data. The study aims to enroll approximately 34,000 participants and evaluates the vaccine's safety and efficacy. RSV significantly impacts older adults, causing around 177,000 hospitalizations and 14,000 deaths annually in the U.S., with a medical cost of about $3 billion. Moderna's goal includes combining the RSV vaccine with boosters for COVID-19 and flu.

Moderna (NASDAQ:MRNA) is expanding its mRNA pipeline with three new vaccine candidates: mRNA-1608 against herpes simplex virus (HSV), mRNA-1468 targeting varicella-zoster virus (VZV) for shingles prevention, and mRNA-4359, a checkpoint cancer vaccine. These developments aim to address lifelong medical conditions caused by latent viruses and to induce immune responses against cancer. Notably, HSV affects 18.6 million adults aged 18-49 in the U.S., while VZV-related shingles incidence is rising with age. Moderna's initiatives reflect its commitment to leveraging mRNA technology.

Moderna (NASDAQ:MRNA) announced that Australia's Therapeutic Goods Administration (TGA) has granted provisional registration for its Spikevax COVID-19 vaccine for children aged 6-11 years. This marks the first regulatory approval for the vaccine in this age group. Data from the Phase 2 'KidCOVE' study showed that the vaccine elicited a strong immune response comparable to that in young adults, with a 99.3% seroresponse rate. The vaccine was well tolerated, supporting its use in this demographic.

Moderna announced its plans to expand its commercial presence in Europe by establishing operations in Belgium, Denmark, the Netherlands, Norway, Poland, and Sweden. This move builds on the company's recent expansion in the Asia-Pacific region. Moderna aims to enhance the delivery of its mRNA vaccines and therapeutics, bolstering its European network where it already has subsidiaries in several major countries. The company has a pipeline of 40 development programs, with 25 in clinical trials, and is working on addressing variants of COVID-19.

Moderna (NASDAQ:MRNA) and Laboratorios Farmacéuticos Rovi (BME: ROVI) have announced a long-term partnership to enhance manufacturing capabilities in Spain. The 10-year agreement includes investments to improve ROVI's facilities in Madrid and other locations, allowing for increased capacity in producing Moderna's COVID-19 vaccine and future mRNA candidates. This collaboration aims to bolster Moderna's production and ROVI's role as a key manufacturer, with expected final details in Q1 2022.