Moderna - MRNA STOCK NEWS

Moderna (NASDAQ:MRNA) announced a $176 million project award from BARDA’s Rapid Response Partnership Vehicle (RRPV) to accelerate mRNA-based pandemic influenza vaccine development. Funded by the U.S. Department of Health and Human Services (HHS), the project supports late-stage development for a pre-pandemic H5 influenza vaccine, addressing the highly infectious avian influenza virus. The agreement also includes options for future public health threat responses. Moderna’s CEO, Stéphane Bancel, highlighted the advantages of mRNA technology demonstrated during the COVID-19 pandemic. A Phase 1/2 study initiated in 2023 for the mRNA-1018 vaccine in adults will provide safety and immunogenicity data by 2024, informing Phase 3 plans.

Moderna has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on the marketing authorization for mRESVIA (mRNA-1345), their mRNA vaccine for respiratory syncytial virus (RSV). This vaccine is intended for adults aged 60 and older to protect against lower respiratory tract disease caused by RSV. The decision by the European Commission on the authorization of mRESVIA is pending.

RSV is a significant cause of lower respiratory infections and pneumonia, particularly affecting older adults. The CHMP's positive opinion is based on Phase 3 clinical trial data from the ConquerRSV study, which involved about 37,000 adults aged 60 and above in 22 countries. The trial showed a vaccine efficacy (VE) of 83.7% against RSV lower respiratory tract disease with a median follow-up of 3.7 months. With an 8.6-month follow-up, the vaccine showed sustained efficacy of 63.3%.

In May 2024, the U.S. FDA approved the vaccine under a breakthrough therapy designation. Moderna has also filed for marketing authorizations in various additional markets globally.

Moderna announced that its Phase 3 trial of mRNA-1283, a next-generation COVID-19 vaccine, met its primary efficacy endpoint.

The vaccine demonstrated non-inferior efficacy compared to Spikevax in participants aged 12 and older and higher efficacy in adults 18 and older.

The trial involved 11,400 individuals, half receiving 10 μg of mRNA-1283 and the other half 50 μg of Spikevax.

mRNA-1283 showed higher neutralizing antibody responses against Omicron BA.4/5 and ancestral SARS-CoV-2, especially in adults and those aged 65 and older.

Safety profiles were similar between mRNA-1283 and Spikevax, with common side effects being injection site pain, fatigue, headache, and myalgia.

Moderna plans to present the data at an upcoming conference and submit it for publication while engaging with regulators on the next steps.

Moderna announced positive results from its Phase 3 trial of the combination vaccine mRNA-1083 against influenza and COVID-19. The trial showed the vaccine elicited higher immune responses than licensed flu and COVID vaccines in adults 50 years and older. The study included approximately 8,000 participants split into two age cohorts: 50-64 and 65+. In both groups, mRNA-1083 significantly outperformed comparator vaccines for three influenza strains and the SARS-CoV-2 Omicron variant. The vaccine was found to be non-inferior in terms of safety and tolerability, with most adverse reactions being mild. Moderna plans to present these findings at a medical conference and seek regulatory approvals.

Moderna has submitted an FDA application for its updated Spikevax 2024-2025 COVID-19 vaccine, targeting the SARS-CoV-2 variant JN.1. The vaccine, based on FDA guidance and WHO recommendations, aims to be ready for shipping by August, pending regulatory approval. CEO Stéphane Bancel emphasizes the importance of staying up-to-date with COVID-19 vaccinations for protection during the respiratory illness season. The submission follows expert advice advocating for a monovalent JN.1 composition. Common adverse events include injection site pain, headache, fatigue, myalgia, and chills. Moderna is also seeking approvals globally to ensure timely distribution.

Moderna's investigational therapeutic mRNA-3705 has been selected by the U.S. FDA for the START pilot program, which aims to accelerate the development of treatments for rare diseases. The FDA's Center for Biologics Evaluation and Research chose mRNA-3705 as one of four investigational medicines for this program. mRNA-3705 targets methylmalonic acidemia (MMA), a rare, life-threatening metabolic disorder. Inclusion in the START program will enhance communication with the FDA, potentially speeding up the pivotal study initiation scheduled for 2024. The Landmark study, evaluating the safety and tolerability of mRNA-3705 in patients with MMA, is currently in Phase 1/2.

Moderna and Merck have reported three-year data from their Phase 2b study showing that the combination of mRNA-4157 (V940) and KEYTRUDA significantly improves recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) in patients with high-risk stage III/IV melanoma. The combination therapy reduced the risk of recurrence or death by 49% and distant metastasis or death by 62% compared to KEYTRUDA alone. The 2.5-year RFS rate for the combination was 74.8% versus 55.6% for KEYTRUDA alone.

The companies have started Phase 3 trials for melanoma and non-small cell lung cancer, and Phase 2 trials for renal and urothelial carcinomas, and a Phase 2/3 trial for cutaneous squamous cell carcinoma. Safety profiles were consistent with previous findings, showing mostly mild to moderate side effects.

Moderna announced that the U.S. FDA has approved its mRNA RSV vaccine, mRESVIA, to protect adults aged 60 and older from lower respiratory tract disease caused by RSV infection. This is Moderna's second approved mRNA product, and the only RSV vaccine available in single-dose pre-filled syringes. The approval is based on positive data from the Phase 3 ConquerRSV trial, which showed a vaccine efficacy of 83.7% and no serious safety concerns. Moderna plans to make mRESVIA available in the U.S. by the 2024/2025 respiratory virus season and has filed for approval in other global markets.

Moderna announced that three abstracts on mRNA-4157 (V940), an investigational mRNA individualized neoantigen therapy, will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 to June 4 in Chicago. The abstracts include studies on V940 combined with pembrolizumab for the treatment of high-risk melanoma and early-stage non-small-cell lung cancer. A three-year update on a study involving V940 and pembrolizumab in resected melanoma will also be presented. Moderna will host an investor event via webcast on June 3 at 6:15 PM CDT.