Moderna Stock Price, News & Analysis

Moderna, Inc. (Nasdaq: MRNA) held its fourth annual Science Day to showcase developments in mRNA therapeutics and vaccines. The event highlights 24 mRNA programs, with 14 in clinical studies, and focuses on the advancements in mRNA delivery, particularly targeting hematopoietic stem cells, and optimizing mRNA engineering for enhanced protein expression. The company is also leveraging AI to address SARS-CoV-2 variants. These efforts underscore Moderna's continuous commitment to innovation in utilizing mRNA for therapeutic purposes.

Moderna (Nasdaq: MRNA) announced that its Phase 2/3 study of the COVID-19 vaccine (mRNA-1273) in adolescents (ages 12-17) successfully met its primary immunogenicity endpoint. The study, enrolling over 3,700 participants, showed no COVID-19 cases in the vaccine group after two doses, achieving 100% efficacy under adult case definitions. Additionally, a 93% efficacy was noted in seronegative participants using a secondary CDC definition after the first dose. The safety profile was consistent with adult studies, prompting plans to submit findings for global regulatory approval in early June.

Moderna (Nasdaq:MRNA) has expanded its collaboration with Aldevron, enhancing support for both the Moderna COVID-19 Vaccine and its clinical development pipeline. Aldevron will supply plasmid DNA, which is essential for generating the mRNA vaccines. This partnership, spanning nearly a decade, aims to leverage Aldevron's manufacturing capabilities, including a newly expanded GMP facility in Fargo, North Dakota. Moderna continues to work on a diverse range of programs, including various therapeutics and vaccines, while maintaining strategic alliances to maximize their operational efficiency.

Moderna (Nasdaq: MRNA) has entered into a Manufacturing Services and Supply Agreement with Samsung Biologics to conduct large-scale commercial fill-finish manufacturing of its COVID-19 vaccine, mRNA-1273. The technology transfer will start immediately at Samsung's Incheon facility, aiming to produce hundreds of millions of doses for markets outside the U.S. by Q3 2021. This partnership enhances Moderna's manufacturing capacity, crucial during the ongoing pandemic. Both companies emphasize the urgency in supplying the vaccine globally.

Moderna has signed two Memoranda of Understanding (MoUs) with the South Korean government to enhance mRNA vaccine research and explore local manufacturing opportunities. The collaborations involve the Korea National Institute of Health and the Ministry of Trade, Industry, and Energy. Additionally, Moderna has entered into a Manufacturing Services and Supply Agreement with Samsung Biologics for COVID-19 vaccine production. Moderna aims to establish a commercial subsidiary in South Korea in 2021, which will support its growing commercial network in the region.

Moderna, Inc. (Nasdaq: MRNA) has received Conditional Marketing Authorization from South Korea's Ministry of Food and Drug Safety for its COVID-19 mRNA vaccine. GC Pharma will distribute the vaccine in South Korea, which has secured 40 million doses. Moderna plans to establish a commercial subsidiary in South Korea in 2021 and is in discussions for local manufacturing opportunities. The vaccine is authorized for adults aged 18 and older, with approvals also secured in multiple countries and from the World Health Organization.

Moderna, Inc. (Nasdaq: MRNA) announced the Ministry of Health, Labour and Welfare (MHLW) of Japan granted emergency use approval for its mRNA COVID-19 vaccine, COVID-19 Vaccine Moderna Intramuscular Injection. Distribution, facilitated by Takeda, starts immediately. This marks Moderna's first product approval in Japan, following positive Phase 3 COVE study results. The vaccine is authorized for adults 18 and older, and initial trials showed an immune response in all participants. Moderna plans to expand its commercial presence in Japan.

Moderna (Nasdaq: MRNA) will host a virtual Science Day for analysts and investors on May 27 at 8:00 a.m. ET. The event will feature presentations from President Stephen Hoge and Chief Scientific Officer Melissa Moore, focusing on the latest advancements in the company's messenger RNA research. A live webcast will be accessible on the Moderna website, and a replay will be available for one year. Moderna has established itself as a leader in mRNA therapeutics and vaccines, with 24 development programs and 14 in clinical trials.

Moderna, Inc. (Nasdaq: MRNA) announced plans to establish an International Business Services Hub in Warsaw, Poland, enhancing its global operational infrastructure. The Moderna International Business Services (MIBS) Center will provide essential services including finance, pharmacovigilance, human resources, and digital services, creating approximately 160 jobs upon full operation by Q3. CEO Stéphane Bancel highlighted Warsaw's favorable business conditions as key to the expansion, which aims to support Moderna’s growing international business and improve operational efficiency.