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.
National Resilience, Inc. and Moderna, Inc. have entered a multi-year agreement for the manufacturing of mRNA for the Moderna COVID-19 vaccine. The mRNA will be produced at Resilience's facility in Mississauga, Ontario, for global distribution. Resilience's CEO, Rahul Singhvi, highlighted the impact of Moderna’s vaccine in saving lives and expressed excitement about this partnership, which aims to enhance vaccination efforts worldwide.
Moderna has announced a collaboration with the Institute for Life Changing Medicines (ILCM) to develop an mRNA therapy, mRNA-3351, for Crigler-Najjar Syndrome Type 1 (CN-1), an ultra-rare genetic disorder affecting about 70-100 individuals globally. This partnership aims to provide the therapy free of charge to patients. Moderna will license mRNA-3351 to ILCM without upfront fees, and ILCM will handle clinical development, projected to start in 2022. This initiative reflects Moderna's commitment to addressing rare diseases without imposing high costs on patients.
Moderna, Inc. (Nasdaq: MRNA) has submitted a request for conditional marketing approval to the European Medicines Agency (EMA) for its COVID-19 vaccine booster dose, mRNA-1273, at a 50 µg level. The amended Phase 2 study involving 344 participants showed that this booster significantly increases antibody responses, particularly against the Delta variant, boosting neutralizing titers above Phase 3 benchmarks. The safety profile after the third dose was similar to that of the second dose, indicating the potential for effective ongoing immunity against COVID-19.
Moderna (NASDAQ: MRNA) announced participation in two virtual investor conferences on September 10, 2021. The Wells Fargo 2021 Virtual Healthcare Conference will begin at 10:00 a.m. ET, followed by the Morgan Stanley 19th Annual Global Healthcare Conference at 11:45 a.m. ET. Live webcasts can be accessed on the Moderna Investors website and will be available for replay for 30 days. Moderna has emerged as a leader in mRNA therapeutics, developing vaccines and treatments across various therapeutic areas.
Moderna (NASDAQ:MRNA) has submitted data to the FDA for a booster dose of its COVID-19 vaccine (mRNA-1273) at a 50 µg dose level. The submission is backed by Phase 2 study data showing significant antibody responses against the Delta variant, exceeding benchmarks. Following the booster, neutralizing antibody titers increased significantly, especially in older adults. The safety profile remained consistent with previous doses. Moderna plans to submit further data to the EMA and other global authorities soon.
Moderna has completed its Biologics License Application (BLA) for the COVID-19 vaccine, requesting Priority Review from the FDA. The final analysis of the Phase 3 COVE study shows the vaccine has a 93% efficacy rate, which remains durable for six months after the second dose. This marks the first BLA submission in Moderna's history. The company aims for full licensure to prevent COVID-19 in individuals aged 18 and older. The vaccine has been available under Emergency Use Authorization since December 2020 and has delivered over 300 million doses to the U.S. government.
Moderna, Inc. (NASDAQ: MRNA) will host its fifth annual virtual R&D Day for analysts and investors on September 9 at 8:00 a.m. ET. Key presentations will be made by CEO Stéphane Bancel, Chief Medical Officer Paul Burton, and other leaders, focusing on Moderna's clinical development pipeline. Registration for the event can be done here. The webcast will also be available on Moderna's investor website and archived for one year.
Azzur Cleanrooms on Demand has expanded its partnership with Moderna, aiming to enhance clinical manufacturing capabilities. This collaboration spans over six years, with Moderna becoming the anchor client at Azzur's new Burlington, MA facility. The partnership aims to tackle production challenges and meet the growing demand for Moderna's products as they expand their clinical manufacturing capacity. Azzur operates multiple COD facilities across the U.S. and plans further expansion into new markets in the coming months.
Moderna, Inc. (Nasdaq: MRNA) announced a revised supply agreement with the Government of Canada for up to 105 million doses of its COVID-19 vaccine through 2024. The agreement stipulates 20 million doses in 2022 and 2023, with an option for an additional 15 million doses each year. For 2024, it allows for up to 35 million doses. Moderna's CEO, Stéphane Bancel, commended the Canadian government's support. This agreement further illustrates Moderna's role in combating the pandemic and highlights the company's ongoing collaboration with governmental partners.
Moderna (Nasdaq: MRNA) has commenced a Phase 1/2 trial for mRNA-3705, an investigational therapy targeting methylmalonic acidemia (MMA) caused by MUT deficiency. The first patient has been enrolled in the study assessing the safety and tolerability of this mRNA therapeutic. MMA is a rare metabolic disorder with no approved treatments, and current options are limited to dietary management and transplants. mRNA-3705 aims to restore missing enzymes to improve patient outcomes. The FDA has granted it Orphan Drug and Rare Pediatric Disease designations.