Moderna Stock Price, News & Analysis

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.

Moderna, Inc. (MRNA) will be presenting at upcoming investor conferences in May and June 2024. The company will participate in events such as Bernstein's 40th Annual Strategic Decisions Conference, Jefferies Healthcare Conference, and Goldman Sachs 45th Annual Global Healthcare Conference. Investors can access live webcasts and replays of these presentations on Moderna's website.

Moderna, Inc. (NASDAQ: MRNA) receives an update from the U.S. FDA regarding the review of its investigational RSV vaccine, mRNA-1345. The FDA will not complete the review by the PDUFA date of May 12, 2024, due to administrative constraints but expects to finish it by the end of May 2024. Moderna remains optimistic about the review and is on track for a CDC Advisory Committee meeting in June 2024.

Moderna reported first quarter revenues of $167 million, with a GAAP net loss of $1.2 billion. The company reaffirmed its 2024 expected product sales of approximately $4 billion. Moderna initiated three new clinical studies for cancer treatment, advanced three new vaccine programs, and provided updates on its COVID-19 and RSV vaccine commercial efforts. Financially, the company saw a decline in revenue due to reduced sales of its COVID-19 vaccine, with cost of sales decreasing by 88%. Research and development expenses decreased by 6% while selling, general, and administrative expenses decreased by 10%. Moderna's net loss was $(1.2) billion, with diluted EPS of $(3.07). The company maintains a cash, cash equivalents, and investments position of $12.2 billion as of March 31, 2024. Looking ahead, Moderna reaffirmed its 2024 revenue expectations, with key milestones in its late-stage pipeline, including respiratory vaccines, next-generation COVID-19 vaccine, and various other vaccine and therapeutics programs.