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, 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.
Moderna (Nasdaq: MRNA) has signed a supply agreement with the Australian government for 25 million COVID-19 vaccine doses. This includes 10 million doses of the original mRNA-1273 vaccine and 15 million doses of an updated variant booster, pending regulatory approval. Moderna plans to submit an application to the Therapeutic Goods Administration of Australia. Additionally, the Company aims to establish a commercial subsidiary in Australia this year. Initial data from a Phase 2 study show increased antibody responses with booster doses, indicating efficacy against variants of concern.
Moderna (Nasdaq: MRNA) announced that CFO David Meline and SVP Lavina Talukdar will partake in a fireside chat at the Bank of America 2021 Healthcare Conference on May 13, 2021, at 11:00 a.m. ET. The event will be available via live webcast on Moderna's investor website, with a replay accessible for 30 days post-event.
Since its inception, Moderna has evolved from a research-stage company to a leader in mRNA therapeutics and vaccines, currently advancing 24 development programs, including 13 in clinical stages.
Moderna, Inc. (Nasdaq: MRNA) reported its first profitable quarter, aiding over 100 million individuals with its COVID-19 vaccine. The company raised its supply forecast for 2021 to 800 million doses, aiming for 1 billion. Promising data from recent clinical trials indicate a 96% vaccine efficacy in adolescents and strong responses to variant booster doses. Additionally, Moderna is expanding its pipeline with 24 mRNA programs, including candidates for RSV and CMV vaccines. The company is set to initiate its Biologics License Application for its COVID-19 vaccine this month.
Moderna (Nasdaq: MRNA) announced a new supply agreement with the Swiss Federal Government to deliver 7 million doses of its booster vaccine in 2022, with an option for an additional 7 million doses for late 2022 or early 2023, contingent on regulatory approval. This follows prior agreements totaling 13.5 million doses. Data from a Phase 2 study indicates that booster doses increased neutralizing antibody responses against SARS-CoV-2 variants. Safety profiles for the booster were comparable to prior doses. Moderna continues to adapt its vaccine to combat emerging variants.
Moderna (MRNA) announced promising data from its Phase 2 study, demonstrating that a 50 µg booster dose of its mRNA-1273.351 vaccine significantly increases neutralizing antibody titers against SARS-CoV-2 and its variants, B.1.351 and P.1. The study found a boost in titers for all participants following the booster. mRNA-1273.351 outperformed mRNA-1273 against B.1.351, with a geometric mean titer of 1400 compared to 864. Safety profiles were comparable to previous doses, with mild to moderate adverse effects. Future data on the multivalent booster mRNA-1273.211 is anticipated.
Moderna, Inc. (Nasdaq: MRNA) has announced an expansion of the Moderna Technology Center in Norwood, MA, set to more than double its space from 300,000 to 650,000 square feet. This growth will enhance production capabilities, particularly for the COVID-19 vaccine, expecting a 50% increase in output by early 2022. The expansion supports plans for global capacity reaching up to 3 billion doses in 2022, and focuses on technical development and preclinical production. The facility integrates advanced technologies and adheres to environmental standards.
Moderna, Inc. (Nasdaq: MRNA) has signed an agreement with Gavi, the Vaccine Alliance to supply up to 500 million doses of its COVID-19 vaccine, including an initial 34 million doses in Q4 2021. This deal supports low- and middle-income countries via the COVAX Facility, furthering Moderna’s commitment to equitable vaccine access. Additionally, the World Health Organization has granted Emergency Use Listing for Moderna's vaccine, enhancing its global reach. The agreement highlights Moderna's pivotal role in combating the COVID-19 pandemic.