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's Spikevax COVID-19 vaccine has received full approval from the U.S. FDA for individuals aged 18 and older. This marks a significant achievement as Spikevax is the company's first product to gain full licensure in the U.S., complementing its existing approvals in over 70 countries, including Canada and the EU. The decision was based on extensive safety and efficacy data, affirming Spikevax's role in combating the pandemic. In 2021, 807 million doses were shipped worldwide, with a significant portion supplied to low- and middle-income countries.
IAVI and Moderna have initiated a Phase 1 clinical trial for an experimental HIV vaccine at George Washington University. The trial aims to evaluate mRNA-based immunogens' ability to induce neutralizing antibodies in healthy participants. Following promising results from a previous trial, this study will examine the effectiveness of the mRNA platform in vaccine design. The trial involves 56 volunteers and aims to produce critical immune responses against HIV variants. Supported by the Bill & Melinda Gates Foundation, this research represents a significant step in HIV vaccine development.
Moderna has commenced the Phase 2 study of its Omicron-specific booster candidate, mRNA-1273.529, with the first participant dosed. The study aims to evaluate the immunogenicity and safety of the booster in two cohorts: those with a primary series of mRNA-1273 and those with an additional 50 µg booster dose. While neutralizing antibodies against Omicron showed a 6.3-fold decline six months post-boost, they remained detectable in all participants. Moderna plans to share findings to inform public health decisions on booster strategies against SARS-CoV-2.
Moderna (NASDAQ:MRNA) reported shipping 807 million doses of its COVID-19 vaccine globally in 2021, with approximately 25% delivered to low- and middle-income countries. The company achieved product sales of about $17.5 billion for the year and has secured advanced purchase agreements (APAs) for 2022 totaling around $18.5 billion. Moderna is expanding its mRNA pipeline with 40 programs, including ongoing studies for COVID-19 and flu vaccines, and has partnered with Carisma Therapeutics for cancer therapy developments. The company remains focused on reinvesting in R&D and expanding its manufacturing capabilities.
On January 10, 2022, Moderna (NASDAQ: MRNA) announced a strategic collaboration with Carisma Therapeutics to develop in vivo engineered chimeric antigen receptor monocyte (CAR-M) therapeutics for cancer treatment. The agreement includes a $45 million upfront cash payment and a $35 million convertible note from Moderna to Carisma. Carisma will handle discovery, while Moderna will lead clinical development and commercialization. This partnership aims to enhance Moderna's oncology pipeline and leverage both companies' expertise in mRNA and engineered macrophages.
Moderna has initiated a Phase 1 study for its mRNA-1189 vaccine targeting Epstein-Barr Virus (EBV), with the first participant dosed. The trial, named Eclipse, aims to enroll approximately 270 participants in the U.S. EBV can cause infectious mononucleosis, with significant health impacts and no current vaccine available. The study will assess the safety and tolerability of mRNA-1189 in adults aged 18-30. Moderna is developing vaccines against latent viruses, expanding its portfolio alongside its CMV vaccine candidate.
Moderna, Inc. (NASDAQ:MRNA) will have its CEO, Stéphane Bancel, participate in a fireside chat at the Goldman Sachs 14th Annual Healthcare CEOs Unscripted Conference on January 6th, 2022, at 2:00 p.m. ET. A live webcast will be accessible in the Investors section of Moderna's website, with a replay available for 30 days post-event. Moderna has evolved over the past decade from an mRNA research-stage company to a leader in mRNA therapeutics and vaccines, contributing significantly to COVID-19 vaccine development.
Moderna, Inc. (Nasdaq:MRNA) will present updates on its mRNA pipeline at the 40th annual J.P. Morgan Healthcare Conference on January 10, 2022, at 8:15 a.m. ET. CEO Stéphane Bancel will lead the presentation. A live webcast will be available on Moderna's investor website, and a recorded version will be accessible for 30 days post-event. Moderna has advanced significantly in mRNA therapeutics and vaccines, particularly in response to the COVID-19 pandemic, and maintains a strong portfolio across various disease modalities.
Moderna, Inc. (NASDAQ:MRNA) announced a revised supply agreement with the South Korean government for 20 million doses of its COVID-19 vaccine or an updated booster candidate. This includes 15 million doses for the third quarter and 5 million doses for the fourth quarter of 2022. CEO Stéphane Bancel expressed gratitude for South Korea's proactive planning for the fall 2022 booster season. The company emphasizes its commitment to combating the COVID-19 pandemic, underscoring its evolution from research to a leading enterprise in mRNA therapeutics and vaccines.
Moderna, Inc. (NASDAQ:MRNA) announced that the Swiss Federal Government has ordered an additional seven million doses of its COVID-19 booster vaccine, increasing the total commitment to 27.5 million doses.
The booster can elevate neutralizing antibody levels against the Omicron variant significantly. Moderna aims to continually enhance its COVID-19 vaccine in response to emerging variants. SPIKEVAX is authorized for individuals 12 and older, and Moderna maintains a broad clinical portfolio across various therapeutic areas.