Welcome to our dedicated page for Moderna news (Ticker: MRNA), a resource for investors and traders seeking the latest updates and insights on Moderna stock.
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 (Nasdaq: MRNA) has confirmed an agreement with Japan's Ministry of Health and Takeda Pharmaceutical to supply 50 million doses of its COVID-19 vaccine candidate, mRNA-1273. This partnership aims to ensure rapid distribution of the vaccine in Japan, pending regulatory approvals. Moderna will handle manufacturing and supply, while Takeda, supported by Japanese authorities, will oversee import and distribution efforts. CEO Stéphane Bancel expressed gratitude to Japanese partners, highlighting the confidence in mRNA-1273 amid promising clinical data.
Moderna, Inc. (Nasdaq: MRNA) announced a supply agreement with Qatar's Ministry of Public Health for its COVID-19 vaccine candidate, mRNA-1273, aiming to enhance access to vaccines in Qatar. The Phase 3 COVE study is fully enrolled with 30,000 participants, demonstrating strong immune responses in interim analyses. Moderna plans to manufacture 500 million to 1 billion doses annually starting in 2021. This development underscores Moderna's commitment to combating the pandemic, leveraging its innovative mRNA technology.
Moderna, Inc. (Nasdaq: MRNA) has completed enrollment of 30,000 participants for its Phase 3 COVE study of mRNA-1273, a COVID-19 vaccine candidate. Over 25,650 participants have received their second dose. The company is collaborating with NIAID and BARDA, prioritizing groups at high risk for severe COVID-19, including 7,000 individuals over 65. Enrollment also included over 11,000 participants from diverse communities, representing 37% of the population. The next steps involve analyzing safety data and determining emergency use authorization based on the potential benefits and risks.
Moderna, Inc. (Nasdaq: MRNA) announced a live conference call on October 29, 2020, at 8:00 a.m. ET to present its third quarter 2020 financial results and provide a corporate update. Interested participants can join via phone or access a webcast from Moderna's Investor Relations website. The call will also feature insights into Moderna's advancements in mRNA technology, focusing on therapeutics and vaccines for various diseases. The archived audio of the call will be available for one year post-event.
Moderna, Inc. (Nasdaq: MRNA) announced receipt of confirmation from the European Medicine Agency (EMA) that its COVID-19 vaccine candidate, mRNA-1273, is eligible for a Marketing Authorization Application in the EU. This follows positive results from preclinical studies and interim analyses of Phase 1 trials. The company plans to scale up production to deliver around 500 million to 1 billion doses annually starting in 2021, collaborating with partners Lonza and ROVI for European manufacturing. The Phase 1 study showed strong immune responses across all age categories.
Moderna (Nasdaq: MRNA) has initiated a rolling submission to Health Canada for its COVID-19 vaccine candidate, mRNA-1273, following positive results from preclinical and Phase 1 studies. This submission allows for ongoing assessments of safety and efficacy data as they become available. The Canadian government has confirmed orders for 20 million doses, with delivery expected in 2021 from European production facilities. The Phase 1 analysis indicated strong immune responses were generated across all age groups, supporting the vaccine's potential effectiveness.
Moderna, Inc. (Nasdaq: MRNA) has secured a commitment of up to $56 million from DARPA to develop a mobile manufacturing prototype. This initiative aims to facilitate rapid production of vaccines and therapeutics in remote locations, aligning with DARPA's NOW program. The prototype can manufacture hundreds of doses within days, enhancing military and civilian healthcare responses. CEO Stéphane Bancel emphasized the potential for this technology to address future viral outbreaks.
Moderna, Inc. (Nasdaq: MRNA) announced the return of all rights to its respiratory syncytial virus (RSV) vaccine (mRNA-1172) from Merck. The transition includes the completion of the Phase 1 study by Merck, which will then be managed by Moderna. This consolidation allows Moderna to focus on RSV vaccines for adults and children. Additionally, Moderna initiated a Phase 1 study for its other RSV candidate (mRNA-1345). The company remains committed to its collaboration with Merck in cancer vaccines while expanding its RSV vaccine efforts.
Moderna (Nasdaq: MRNA) announced the second interim analysis of its Phase 1 study for mRNA-1273, a COVID-19 vaccine. The study involved 40 healthy adults, with two doses (25 µg and 100 µg) evaluated. Results showed both doses were well-tolerated, with the 100 µg dose eliciting stronger immune responses. Notably, binding and neutralizing antibody levels were comparable between older adults and younger cohorts. The U.S. government has purchased 100 million doses with an option for 400 million more, indicating strong market potential for Moderna's vaccine.
Moderna (Nasdaq: MRNA) announced that Dr. Stephen Hoge, President, will speak at the Chardan Virtual 4th Annual Genetic Medicines Conference on October 5, 2020, at 2:00 p.m. ET. A live webcast of the event will be available in the Investors section of Moderna's website, with a replay accessible for 30 days afterward. Moderna is focused on advancing mRNA science for transformative medicines addressing various diseases and has collaborations with major organizations like AstraZeneca and Merck.