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. 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) has secured approval from the European Commission for an agreement to supply 80 million doses of its COVID-19 vaccine candidate, mRNA-1273. The contract, which can be expanded to 160 million doses, marks a significant step in the EU's efforts to secure access to effective vaccines. Pending regulatory approvals, deliveries may commence as early as Q1 2021. Moderna's vaccine has shown a promising efficacy rate of 94.5% in Phase 3 trials. The company is on track to manufacture up to 1 billion doses globally in 2021.
Moderna, a biotechnology company based in Cambridge, announced that the European Medicines Agency (EMA) has initiated a rolling review of its COVID-19 vaccine candidate, mRNA-1273. This follows the confirmation of eligibility for submission on October 14, 2020. The Phase 3 study of mRNA-1273 has reported an efficacy of 94.5%, involving over 30,000 participants. Moderna aims to scale up production to deliver 500 million doses annually, potentially reaching 1 billion doses by 2021, in collaboration with strategic partners Lonza and ROVI.
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.
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