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 entered a supply agreement with the U.K. government to provide mRNA-1273, its COVID-19 vaccine candidate, starting in March 2021, pending regulatory approval. The U.K. aims to secure safe and effective COVID-19 vaccines. The Phase 3 COVE study shows mRNA-1273 has a vaccine efficacy of 94.5% with over 30,000 participants. Moderna continues to strengthen its manufacturing capabilities, targeting delivery of 500 million to 1 billion doses annually beginning in 2021, aided by partnerships with Lonza and ROVI.
Moderna (Nasdaq: MRNA) announced that its Phase 3 COVE study for mRNA-1273, a COVID-19 vaccine, met pre-specified efficacy criteria with a vaccine efficacy of 94.5%. The interim analysis included over 30,000 participants and showed only 5 COVID-19 cases in the vaccine group versus 90 in the placebo group. The Data Safety Monitoring Board reported no significant safety concerns. Moderna plans to submit for Emergency Use Authorization (EUA) with the FDA, anticipating 20 million doses ready for distribution in the U.S. by year-end 2020.
Moderna (Nasdaq: MRNA) announces new data confirming that its COVID-19 vaccine candidate, mRNA-1273, remains stable at 2° to 8°C for 30 days, extending previous estimates from 7 days. The vaccine can also be stored at -20°C for up to six months and room temperature for 12 hours. These stability improvements are crucial for distribution across pharmacies and hospitals, facilitating wider vaccinations. Moderna is working with regulatory bodies to submit this data for approval while ensuring vaccine accessibility and streamlined logistics.
Moderna (Nasdaq: MRNA) announced that Swissmedic has initiated a rolling review of its COVID-19 vaccine candidate, mRNA-1273. This follows positive results from a preclinical study and interim analysis of Phase 1 trials showing strong immune responses. The rolling review allows for quicker authorization, contingent on meeting Swissmedic's safety and efficacy standards. Moderna completed enrollment for its Phase 3 COVE study with 30,000 participants, focusing on the vaccine's effectiveness across age groups. CEO Stéphane Bancel expressed optimism about the collaboration with Swissmedic, highlighting promising data.
Moderna, Inc. (Nasdaq: MRNA) announced the completion of case accrual for the first interim analysis of its Phase 3 COVE study of mRNA-1273, a COVID-19 vaccine candidate. With significantly increased case identification, the analysis will include more than the targeted 53 cases. The COVE study enrolled 30,000 participants, focusing on those at high risk for severe COVID-19. The study aims to prevent symptomatic and severe disease, with results expected to influence regulatory decisions.
Moderna, Inc. (Nasdaq: MRNA) has released interim data from its Phase 1 study of the mRNA personalized cancer vaccine (PCV) mRNA-4157, presented at SITC 2020. The study involved 10 HPV(-) Head and Neck Squamous Cell Carcinoma patients and 17 Micro-Satellite Stable Colorectal Cancer patients. Notably, 50% of patients in the HPV(-) cohort experienced tumor shrinkage, with two achieving complete responses. The overall disease control rate was 90%, and median progression-free survival reached 9.8 months. Moderna plans to expand the cohort based on this encouraging data.
Moderna (Nasdaq: MRNA) announced its participation in two upcoming investor conferences. The Credit Suisse 29th Annual Virtual Healthcare Conference will take place on November 11, 2020, at 8:00 a.m. ET, followed by the Jefferies Virtual London Healthcare Conference on November 18, 2020, at 11:25 a.m. ET. Live webcasts of these presentations will be accessible on Moderna's website under the 'Events and Presentations' section, with replays available for 30 days following each event.
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.
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