Moderna Stock Price, News & Analysis

Moderna's mRNA-1273.214 has shown significantly higher antibody responses against various COVID-19 variants, including Omicron subvariants BA.4 and BA.5, versus the current booster. The company has completed regulatory submissions in the EU, UK, and Australia, with more filings expected shortly. Additionally, Moderna is developing another bivalent candidate, mRNA-1273.222, following FDA guidance. Data indicates a geometric mean ratio of 1.69 for neutralizing titers and a 6.3-fold increase in BA.4/5 responses.

Moderna, Inc. (NASDAQ:MRNA) announced promising results from its Phase 2/3 study on the bivalent COVID booster candidate, mRNA-1273.214. This booster demonstrated a greater than 5-fold increase in neutralizing antibodies against the Omicron subvariants BA.4 and BA.5 one month post-administration, showing a neutralizing GMT of 941 for all participants. The company plans to submit this data to regulators and prepare for supply in August, anticipating a rise in infections. The bivalent vaccine is considered essential for addressing the evolving SARS-CoV-2 variants.

Moderna has announced a collaboration with the UK government to establish an mRNA Innovation and Technology Center. This facility aims to enhance access to domestically manufactured vaccines targeting respiratory viruses, including COVID-19 and seasonal influenza. Moderna plans to increase its R&D investments in the UK, supporting rapid pandemic responses as part of the UK’s '100 Days Mission'. A recent purchase agreement was made for 60 million doses of Moderna’s COVID-19 vaccine for delivery over 2022 and 2023.

Moderna, Inc. has received emergency use authorization (EUA) from the FDA for its COVID-19 vaccine mRNA-1273 for children aged 6 months to 17 years. This vaccine is administered in two doses tailored for specific age groups, initiating protection as children return to school. The safety and efficacy data from clinical trials involving over 14,000 children show significant antibody responses and comparable efficacy to adults. The vaccine will be available at select sites, allowing millions of children to receive protection against COVID-19.

Moderna has announced promising clinical data for its COVID-19 booster candidate, mRNA-1273.214, demonstrating an 8-fold increase in neutralizing geometric mean titers against the Omicron variant compared to the original vaccine. The study met all primary endpoints, confirming superior antibody response and safety profiles comparable to the original mRNA-1273. A regulatory submission is planned in the coming weeks to enable its use as a Fall booster. Moderna anticipates more durable protection against variants with this new bivalent candidate, marking a significant advancement in the fight against COVID-19.

Moderna's seasonal influenza vaccine candidate, mRNA-1010, has entered a Phase 3 trial, marking a significant milestone as the company's first flu vaccine to reach this stage. Approximately 6,000 adults in the Southern Hemisphere will participate in this randomized, observer-blind study aimed at evaluating safety and immunological non-inferiority compared to licensed vaccines. Moderna is advancing its respiratory portfolio, which includes multiple mRNA vaccine candidates, with expectations of commercial launches for three respiratory vaccines in the next two to three years.

Moderna (NASDAQ:MRNA) announced an amendment to its COVID-19 vaccine supply agreement with the European Commission, allowing the delivery of booster doses to be postponed to later in 2022 or early 2023. This includes the potential for updated bivalent vaccine candidates pending approval. Moderna expects approximately $21 billion in advanced purchase agreements for 2022, anticipating higher sales in the latter half of the year compared to the first half. The company is currently evaluating a new booster candidate, mRNA-1273.214, with initial data expected in June.

Moderna (NASDAQ:MRNA) announced its upcoming participation in two major investor conferences: the 2022 Jefferies Healthcare Conference on June 8 at 3:00 p.m. ET and the 43rd Annual Goldman Sachs Global Healthcare Conference on June 14 at 12:20 p.m. ET. Live webcasts will be available on the Moderna investor website, with replays archived for at least 30 days. Moderna has evolved from a research-stage company to a leader in mRNA therapeutics, having developed vaccines and therapeutics for various diseases, including a highly effective COVID-19 vaccine.

Moderna has announced that it will assume the role of marketing authorization holder for its COVID-19 vaccine Spikevax™ in Japan starting August 1, 2022. This transition includes taking over all related activities, such as import, regulatory compliance, development, quality assurance, and commercialization. In a collaborative effort, Takeda will continue to provide distribution support during a transitional phase of the national vaccination campaign. Both companies aim to ensure smooth operational implementation during this handover.