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'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.
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