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.
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.
Moderna, Inc. (NASDAQ:MRNA) announced the immediate departure of its Chief Financial Officer, Jorge Gomez, amidst an ongoing internal investigation at his previous employer, Dentsply Sirona Inc. In light of this, David Meline, the recently retired CFO, will resume his role as CFO while the company searches for a new candidate. Moderna emphasizes that these changes come with risks and uncertainties, and encourages stakeholders to refer to its latest filings for detailed risk factors.
Moderna (NASDAQ:MRNA) will host its in-person Science and Technology Day for analysts and investors on May 17, 2022, at 9:00 a.m. ET in Boston, MA. Key presentations will be made by President Stephen Hoge, Chief Scientific Officer Melissa Moore, and other scientists highlighting advances in mRNA technology.
A live webcast will be available on Moderna's investor website, with a replay accessible for one year. Moderna has transformed significantly over the past decade, developing a diverse portfolio of vaccines and therapeutics, particularly noted for its effective COVID-19 vaccine.
Moderna reported strong Q1 2022 results, achieving revenues of $6.1 billion and a net income of $3.7 billion, resulting in a diluted EPS of $8.58. The company reaffirmed its 2022 advance purchase agreements totaling $21 billion and outlined plans for four Phase 3 programs in the second quarter, including COVID booster and flu vaccines. Moderna's pipeline now has 46 programs with 29 in clinical trials, showing robust progress in both preventive and therapeutic mRNA applications.
Moderna (NASDAQ: MRNA) has submitted a variation for conditional marketing authorization to the European Medicines Agency (EMA) for its COVID-19 vaccine, Spikevax, targeting children six months to under six years. This follows the EMA's positive recommendation for use in children aged six years and older. Positive interim results indicated strong antibody responses and a favorable safety profile from the Phase 2/3 KidCOVE study. Efficacy estimates for the younger age group showed 51% effectiveness against Omicron. The company also continues to explore booster doses for pediatric populations.
Moderna plans to establish a state-of-the-art mRNA vaccine manufacturing facility in Quebec, with an annual production capacity of up to 100 million doses. This facility is part of a ten-year strategic partnership with the Government of Canada aimed at enhancing pandemic preparedness. Following the expected certification by Health Canada, the facility will produce vaccines for respiratory viruses, including COVID-19. Construction is set to begin in 2022, with operations anticipated by 2024, creating hundreds of jobs and bolstering Canada's life sciences ecosystem.
Moderna, Inc. (NASDAQ: MRNA) has submitted a request for emergency use authorization (EUA) of its COVID-19 vaccine, mRNA-1273, for children aged 6 months to under 6 years. This submission is based on positive results from the Phase 2/3 KidCOVE study, which showed a robust antibody response and favorable safety profile. Vaccine efficacy was reported at 51% for the 6 months to 2 years age group and 37% for the 2 years to < 6 years group, similar to adult efficacy. The EUA submission will be finalized next week as Moderna continues to research booster doses for pediatric cohorts.
Moderna has appointed Arpa Garay as the new Chief Commercial Officer, effective May 31, 2022. Ms. Garay brings over 16 years of experience from Merck & Co., where she was Chief Marketing Officer and led significant global marketing strategies. Her extensive background in oncology and digital marketing is expected to bolster Moderna's commercial efforts in mRNA therapeutics. Moderna emphasizes its commitment to innovative therapies, aiming to leverage Ms. Garay's expertise to enhance patient outcomes worldwide.
Moderna's bivalent booster candidate mRNA-1273.211 shows enhanced neutralizing titers against COVID-19 variants, including Omicron. This candidate demonstrated superiority for six months after administration against variants of concern. The tolerability and safety were consistent with the authorized mRNA-1273 booster. Additionally, Moderna is assessing another bivalent booster, mRNA-1273.214, in a Phase 2/3 study, with data expected in Q2 2022. These findings support Moderna's strategy to address ongoing virus mutations and enhance vaccine effectiveness.