Moderna Stock Price, News & Analysis

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.

Moderna, Inc. (Nasdaq: MRNA) announced FDA approval for a third dose of its COVID-19 vaccine (mRNA-1273) for immunocompromised individuals 18 and older. This decision is based on recent studies indicating enhanced immune responses in this population. The vaccine has previously received emergency use authorization and is actively utilized across over 50 countries. Moderna's CEO emphasized the commitment to improving protection against COVID-19, particularly for those at higher risk. The company continues to research the vaccine's effectiveness against variants.