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Moderna, Inc. (NASDAQ: MRNA) is a cutting-edge biotech company based in Cambridge, Massachusetts, founded in 2010. Moderna is at the forefront of pioneering messenger RNA therapeutics™, a revolutionary class of drugs that utilize mRNA technology to direct cells to produce proteins that can fight diseases. This innovative approach has shown promise in addressing targets that were previously considered untreatable with traditional drugs.
With over 200 patent applications and more than 10,000 claims, Moderna has a robust intellectual property portfolio that includes novel nucleotide chemistries and specific drug compositions. The company has successfully developed and commercialized several mRNA-based drugs, initially focusing on rare diseases and oncology, while partnering to advance drug candidates in other therapeutic areas.
Moderna’s mRNA technology gained global recognition with its COVID-19 vaccine, Spikevax®, which was one of the earliest vaccines to receive emergency use authorization in the United States in December 2020. As of mid-2023, Moderna had 39 mRNA development candidates in clinical trials, covering a wide range of therapeutic areas such as infectious diseases, oncology, cardiovascular diseases, and rare genetic disorders.
Some of Moderna's recent achievements include the advancement of three new vaccine programs—targeting Epstein-Barr virus, Varicella-Zoster virus, and norovirus—towards Phase 3 clinical trials. Additionally, the company initiated three new clinical studies combining its investigational individualized neoantigen therapy with Merck’s Keytruda® for treating various cancers.
Financially, Moderna reported first-quarter revenues of $167 million in 2024, with a GAAP net loss of $1.2 billion. Despite the decline in COVID-19 vaccine sales, the company reaffirms its 2024 expected product sales of approximately $4 billion. Moderna is preparing for the launches of its RSV vaccine and the Spikevax® 2024-2025 formula, demonstrating its commitment to fighting respiratory illnesses.
Moderna continues to focus on innovation and operational efficiency, utilizing AI technologies to enhance productivity. The company's long-term vision includes leveraging its mRNA platform to develop therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, and autoimmune diseases, striving to make a significant impact on global health.
Moderna, Inc. (Nasdaq: MRNA) announced that Qatar's Ministry of Public Health granted emergency use authorization for the COVID-19 Vaccine Moderna. This authorization is a significant milestone in the global fight against COVID-19, reflecting confidence in Moderna's mRNA vaccine. The approval is based on scientific evidence from a Phase 3 clinical study. The vaccine has already been authorized in multiple regions, including the U.S., EU, and UK. Moderna remains committed to working with global health agencies to expand its vaccine's availability.
Moderna, Inc. (Nasdaq: MRNA) announced supply agreements for its COVID-19 Vaccine Moderna with Taiwan (5 million doses) and Colombia (10 million doses). Deliveries are set to commence in mid-2021, pending regulatory approvals in both countries. The vaccine is based on mRNA technology and has received various authorizations globally. Moderna emphasizes collaboration with both governments in this effort.
Moderna (Nasdaq: MRNA) will host a live conference call on February 25, 2021, at 8:00 a.m. ET to discuss its fourth quarter and full year 2020 financial results. The call can be accessed by dialing 866-922-5184 domestically or 409-937-8950 internationally, with conference ID 4066945. Moderna has evolved significantly over the past ten years, moving from research-stage activities to commercial success, primarily recognized for its COVID-19 vaccine, now widely used. The company has 24 development programs, with 13 in clinical stages across various therapeutic areas.
Moderna, Inc. (Nasdaq: MRNA) has received interim authorization from the Singapore Health Sciences Authority for its mRNA COVID-19 vaccine under the Pandemic Special Access Route. This decision marks a significant milestone in the global COVID-19 response. The authorization is based on extensive scientific evidence, including data from its pivotal Phase 3 clinical trial. Moderna's vaccine is already approved in several countries, including the U.S., Canada, and the EU. The company continues to advance mRNA technology for various therapeutic areas, supported by strategic alliances with major pharmaceutical firms.
Moderna (Nasdaq: MRNA) announced an increase in its COVID-19 vaccine supply agreement with the Swiss Federal Government from 7.5 million to 13.5 million doses. This decision underscores the government's confidence in Moderna, with deliveries starting in summer 2021 and an option for additional doses in early 2022. The vaccine was authorized by Swissmedic, supporting Moderna's expansion strategy beyond North America. The company continues to enhance its mRNA vaccine platform, which has gained regulatory approval and shows promise in various therapeutic areas.
Moderna (Nasdaq: MRNA) is in discussions with the U.S. government for an additional 100 million doses of its COVID-19 vaccine, aiming for delivery in Q3 2021. This new agreement would increase the total doses to 300 million. Moderna leverages its U.S. manufacturing capacity to fulfill this order. The vaccine received Emergency Use Authorization from the FDA on December 18, 2020, and has been pivotal in the fight against the pandemic. However, the press release includes various safety considerations and potential risks associated with vaccine administration.
Moderna, Inc. (Nasdaq: MRNA) has supplied 30.4 million doses of its COVID-19 vaccine to the U.S. government, with 10.1 million administered in the country. The company is on track to deliver 100 million doses by the end of Q1 2021 and 200 million total by the end of Q2 2021. Moderna has increased its global production estimate for 2021 from 500 to 600 million doses, aiming for up to 1 billion doses. The vaccine has received Emergency Use Authorization from the FDA, and additional authorizations are pending in other countries.
Moderna, Inc. (Nasdaq: MRNA) announced a conference call on January 25 at 4:30 PM ET to discuss in vitro neutralization studies of its COVID-19 vaccine against emerging SARS-CoV-2 strains. The findings indicate that the vaccine retains neutralizing activity, a critical factor in ongoing pandemic response efforts. The call will also be accessible via a webcast. Over the past decade, Moderna has evolved significantly, demonstrating its mRNA technology's potential with multiple vaccines and therapies in development, enhancing its position in the biotechnology field.
Moderna (Nasdaq: MRNA) announced in vitro neutralization data for its COVID-19 Vaccine against emerging variants B.1.1.7 and B.1.351. The vaccine demonstrated strong neutralizing titers against B.1.1.7, with no significant decline. However, a six-fold reduction was observed against B.1.351, although levels remained protective. The company plans to conduct a Phase 1 trial for an emerging variant booster candidate, mRNA-1273.351. CEO Stéphane Bancel emphasized the importance of being proactive against evolving virus strains.
Moderna Inc (Nasdaq: MRNA) has initiated a Phase 1/2 clinical trial for its COVID-19 vaccine candidate (mRNA-1273 or TAK-919) in Japan, in partnership with Takeda Pharmaceutical Co. The study will involve 200 healthy adults and will assess the vaccine's safety and immunogenicity. Participants will receive two vaccinations 28 days apart. Pending licensure, Takeda plans to import and distribute 50 million doses starting in the first half of 2021. This represents Moderna's first clinical trial in Japan, aiming to enhance the country's COVID-19 vaccination efforts.