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. 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.
Moderna announces it will take over as the marketing authorization holder for its COVID-19 vaccine, SpikevaxTM, in Japan starting August 1, 2022. This transition from Takeda includes responsibilities for import, local regulations, development, quality assurance, and commercialization. Takeda will continue to provide distribution support during a transitional period. This move aims to strengthen Moderna's commercial organization in Japan as it continues to combat the COVID-19 pandemic.
Moderna (Nasdaq: MRNA) will participate in a fireside chat at the UBS 2022 Global Healthcare Conference on May 24 at 9:15 a.m. ET. A live webcast will be available on the company's investor website, with a replay accessible for 30 days post-event. Moderna, known for its mRNA technology, has evolved from a research company to a leader in developing vaccines and therapeutics across various diseases, including COVID-19, reinforcing its position in the biopharmaceutical sector.
IAVI and Moderna announced a Phase I clinical trial in Rwanda and South Africa to assess the safety and immunogenicity of an mRNA HIV vaccine antigen (mRNA-1644). This trial, known as IAVI G003, follows promising results from a prior study that indicated 97% of participants developed targeted immune responses. The trial aims to enroll 18 healthy, HIV-negative adults who will receive two doses of the vaccine. This initiative is supported by the U.S. government and the Bill & Melinda Gates Foundation, aiming to strengthen scientific capacity in regions heavily impacted by HIV.
Moderna detailed advancements in its mRNA platform during its 5th Annual Science and Technology Day, focusing on innovative delivery methods, including pulmonary applications. The company is collaborating with Vertex to develop treatments for cystic fibrosis via inhalation. Evidence supports the safety of its COVID-19 vaccines for pregnant and breastfeeding women. The firm emphasizes the importance of mRNA stability for product shelf-life, achieving improved manufacturing processes. Moderna's ongoing research aims to optimize clinical applications of mRNA across various diseases.