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. (NASDAQ: MRNA) is a biotechnology company focused on mRNA medicines, with multiple approved vaccines and a broad clinical pipeline. The MRNA news page on Stock Titan aggregates company announcements, investor updates and regulatory developments so readers can follow how Moderna’s strategy and pipeline progress translate into real-world events.
Investors and observers can use this feed to track commercial updates on products such as Spikevax, mRESVIA and mNEXSPIKE, along with developments in late-stage respiratory programs like the seasonal influenza vaccine mRNA-1010, the flu/COVID combination vaccine mRNA-1083 and the Norovirus vaccine candidate mRNA-1403. News items often cover regulatory submissions and opinions from agencies including the U.S. Food and Drug Administration, the European Medicines Agency, Health Canada and others.
The page also surfaces pipeline and clinical trial news in oncology and rare diseases, including updates on mRNA-4157 (intismeran autogene), mRNA-4359, mRNA-3927 for propionic acidemia and mRNA-3705 for methylmalonic acidemia. Announcements related to partnerships, such as CEPI’s funding commitment for the H5 pandemic influenza vaccine candidate mRNA-1018, appear here as well.
In addition, the MRNA news feed includes financial results, guidance and capital structure updates, such as quarterly earnings releases, multi-year financial frameworks and information on facilities like the $1.5 billion credit agreement. Corporate items, including participation in healthcare conferences, Analyst Day presentations and shareholder meeting outcomes, are also reflected.
By reviewing this consolidated news stream, readers can see how Moderna’s respiratory vaccine franchise, oncology and rare disease programs, manufacturing expansion and financing decisions evolve over time, all based on the company’s own disclosures and related announcements.
Moderna and Merck have received Breakthrough Therapy Designation from the FDA for their investigational personalized mRNA cancer vaccine mRNA-4157/V940. This designation is based on promising results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial, showcasing efficacy in combination with Merck's KEYTRUDA for treating high-risk melanoma post-surgery. The designation expedites development for serious conditions with significant unmet needs. The companies plan to launch a Phase 3 study in adjuvant melanoma in 2023, with the potential to broaden to other cancers, including non-small cell lung cancer.
Moderna has entered a strategic collaboration with Life Edit Therapeutics to develop innovative in vivo gene editing therapies using mRNA technology. This alliance aims to tackle challenging genetic diseases by combining Life Edit's advanced gene editing capabilities, including base editing, with Moderna's mRNA platform. Life Edit will receive an upfront cash payment, ongoing funding for research, and potential milestone payments, along with tiered royalties on global product sales. This partnership exemplifies a commitment to pioneering new therapeutic approaches and broadening the landscape of gene editing.
Health Canada has authorized Moderna's bivalent Omicron-targeting COVID-19 vaccine, mRNA-1273.214, for use in children and adolescents aged 6 to 17. This authorization includes a 25 µg dose for ages 6 to 11 and a 50 µg dose for those aged 12 to 17. Clinical trials demonstrated that both bivalent vaccines (mRNA-1273.214 and mRNA-1273.222) induced superior antibody responses compared to the original vaccine. CEO Stéphane Bancel emphasized the importance of this authorization for broader protection against emerging variants. The decision follows successful Phase 2/3 trials, reinforcing Moderna's commitment to combat COVID-19.
Moderna announced interim results from its Phase 3 trial of mRNA-1010, a seasonal influenza vaccine candidate. The trial showed superiority in seroconversion rates for A/H3N2 and A/H1N1 strains and non-inferiority for A/H1N1 geometric mean titer ratios. However, non-inferiority was not met for the influenza B strains. The vaccine was well-tolerated, with a reported 70% of recipients experiencing minor adverse reactions. The ongoing efficacy study has recorded over 200 PCR-confirmed cases, primarily of influenza A. An interim analysis is expected by the end of Q1 2023. mRNA-1010 is one of five influenza candidates being evaluated by Moderna.
Personalis, Inc. (PSNL) and Moderna, Inc. (MRNA) have signed a new agreement to utilize the Personalis NeXT Platform for clinical studies involving the investigational personalized cancer vaccine, mRNA-4157/V940. This platform previously supported the Phase 2b clinical study, sequencing genomic data from patient tumor samples to identify mutations that may prompt tailored antitumor responses. Chris Hall from Personalis expressed excitement about continuing their collaboration with Moderna, emphasizing the aim to advance individualized cancer treatments.
Moderna, Inc. (NASDAQ:MRNA) will host a live conference call and webcast on February 23, 2023, at 8:00 a.m. ET to report its fourth quarter and full year 2022 financial results.
The call will provide a corporate update, and a webcast will be available in the Investors section of the Moderna website.
Since its inception, Moderna has evolved from a research-stage company to a major biotechnology enterprise with a diverse clinical portfolio, strong manufacturing capabilities, and significant mRNA technology advancements.
Moderna, Inc. (NASDAQ:MRNA) announced that its investigational mRNA vaccine candidate, mRNA-1345, for respiratory syncytial virus (RSV) has received Breakthrough Therapy Designation from the FDA. This designation is granted based on the positive topline data showing an efficacy of 83.7% against RSV lower respiratory tract disease in adults aged 60 and older, as observed in the ConquerRSV Phase 3 trial. The vaccine was well tolerated, with mild side effects reported. Moderna plans to submit a licensing application in the first half of 2023, aiming to address the significant health impact of RSV in older adults.
Moderna's mRNA-1345 has shown a vaccine efficacy of 83.7% against RSV lower respiratory tract disease in adults over 60, based on results from the Phase 3 ConquerRSV trial with 37,000 participants across 22 countries. The Data and Safety Monitoring Board (DSMB) found no safety concerns, indicating the vaccine was well-tolerated. Moderna plans to seek regulatory approval in the first half of 2023. This marks a significant step in addressing the public health burden of RSV, which significantly affects older adults, leading to thousands of hospitalizations each year. Further detailed results are expected to be presented at an upcoming conference.
Moderna reported unaudited COVID-19 vaccine sales of approximately $18.4 billion for 2022, expecting a minimum of $5.0 billion in 2023 from confirmed contracts. The company has 48 programs in development, including 36 in clinical trials, and plans to increase R&D investment to $4.5 billion for 2023. Key updates include advancing RSV and flu vaccine trials, a promising cancer treatment in collaboration with Merck, and ongoing studies for rare diseases, including propionic acidemia. Moderna's strong cash position exceeds $18 billion.
Moderna and CytomX have announced a collaboration to develop mRNA-based conditionally activated therapies. CytomX will receive an upfront payment of $35 million, including $5 million in research funding, and could earn up to $1.2 billion in milestone payments. This partnership aims to leverage Moderna's mRNA technology and CytomX's Probody platform to create innovative therapeutics for oncology and beyond. Moderna will lead clinical development, while CytomX retains rights to royalties on net sales of commercialized products.