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Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada, is a renowned American multinational pharmaceutical company headquartered in Rahway, New Jersey. Originally the American arm of Germany's Merck Group founded in 1668, Merck has established itself as a global leader in pharmaceuticals and vaccines.
Merck's core business is the development and manufacturing of medications and vaccines spanning several therapeutic areas such as cardiometabolic diseases, cancer, and infections. The company's immuno-oncology platform, particularly strong in cancer treatment, is a significant revenue driver. The firm’s oncology portfolio includes groundbreaking immunotherapies like KEYTRUDA, designed to treat melanoma and other cancers. KEYTRUDA, in combination with other therapies, has shown promising results in reducing cancer recurrence and improving survival rates.
Merck also boasts a robust vaccine business, offering vaccines for pediatric diseases and human papillomavirus (HPV). Their commitment to public health extends to Merck for Mothers, an initiative aimed at improving maternal health globally. In 2024, Merck surpassed its goal early by reaching over 30 million women with programs promoting safe, high-quality maternal care.
The company's animal health division is another sector of its diverse operations, providing solutions to improve animal health and productivity.
From a geographical perspective, nearly half of Merck's sales are generated in the United States. Financially, Merck maintains a solid position with ongoing investments in research and development to fuel innovation. The company is actively engaged in numerous partnerships and collaborative research initiatives to accelerate the development of new therapies.
Merck’s mission is rooted in scientific excellence and an unwavering commitment to improving lives. The company continues to invest in leading-edge research, with over 2,250 ongoing clinical trials, including more than 1,600 trials evaluating combination regimens. This dedication underpins Merck's strategy to address complex health challenges and advance global health.
AstraZeneca and Merck (NYSE: MRK) announced that the FDA has accepted their supplemental New Drug Application for LYNPARZA in combination with abiraterone and prednisone for treating metastatic castration-resistant prostate cancer (mCRPC). The FDA granted priority review status, with a decision expected in Q4 2022. In the PROpel trial, the combination showed a 34% reduction in disease progression risk, with median radiographic progression-free survival of 24.8 months compared to 16.6 months for placebo. Merck aims to address significant unmet needs in mCRPC treatment.
Merck (NYSE: MRK) and Orna Therapeutics have entered a strategic collaboration to develop vaccines and therapeutics targeting infectious diseases and oncology. Merck will pay Orna $150 million upfront and an additional $3.5 billion in potential milestones, plus royalties on approved products. Merck will also invest $100 million in Orna's Series B financing. Orna retains rights to its innovative oRNA technology platform, which has shown stability and effectiveness in therapeutic applications, promising advancements in RNA-based treatments.
The European Commission has approved LYNPARZA as the first PARP inhibitor for adjuvant treatment in adults with germline BRCA mutations and HER2-negative early breast cancer, based on the Phase 3 OlympiA trial results. LYNPARZA showed a 42% reduction in the risk of invasive disease recurrence and a 32% reduction in mortality compared to placebo. AstraZeneca will receive a $75 million payment from Merck due to this approval. This milestone indicates a shift in treatment options for high-risk patients, aiming to decrease recurrence rates.
Merck (NYSE: MRK) and Eisai announced that the Phase 3 LEAP-002 trial of KEYTRUDA combined with LENVIMA did not meet its primary endpoints for overall survival (OS) and progression-free survival (PFS) in unresectable hepatocellular carcinoma (uHCC). Although there were trends indicating potential benefits of the combination over LENVIMA monotherapy, results lacked statistical significance. The safety profile matched previous data. Merck and Eisai will showcase findings at a medical conference while continuing research on this combination across various cancers.
Merck (NYSE: MRK) announced that the Phase 3 KEYNOTE-921 trial for KEYTRUDA combined with chemotherapy (docetaxel) failed to meet its primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC). Despite modest trends favoring the combination, results lacked statistical significance. The safety profile of KEYTRUDA remained consistent with previous studies. Merck continues its commitment to developing new treatments for prostate cancer through various ongoing trials.
Merck reported robust financial performance for Q2 2022, with worldwide sales of $14.6 billion, a 28% increase from Q2 2021. Key drivers included KEYTRUDA sales rising 26% to $5.3 billion and GARDASIL growing 36% to $1.7 billion. Non-GAAP EPS improved to $1.87. The company received FDA approval for VAXNEUVANCE, and expanded indications for KEYTRUDA. Merck raised its full-year sales guidance to between $57.5 billion and $58.5 billion, reflecting a growth expectation of 18% to 20% despite foreign exchange impacts.
Merck (NYSE: MRK) announced a quarterly dividend of
Merck aims to lead in biopharmaceuticals while promoting diversity and sustainability in its operations. The company recognizes various risks and uncertainties affecting its performance, including market conditions and regulatory challenges.
Merck (NYSE: MRK) announced that its Phase 3 KEYNOTE-412 trial of KEYTRUDA® (pembrolizumab) combined with chemoradiation therapy for unresected locally advanced head and neck squamous cell carcinoma (HNSCC) failed to meet its primary endpoint of event-free survival (EFS). While the trial showed some improvement in EFS compared to placebo, it did not achieve statistical significance. Despite this setback, Merck remains committed to exploring KEYTRUDA regimens for HNSCC in earlier disease stages, with plans to present detailed results at a medical meeting.
Merck (NYSE: MRK) has entered a global agreement with Orion for the development and commercialization of the investigational drug ODM-208, designed to inhibit CYP11A1, crucial in steroid production. Merck will pay Orion
Merck (NYSE: MRK) has launched the Merck Digital Sciences Studio (MDSS) aimed at fostering innovation in drug discovery by supporting early-stage biomedical startups. The MDSS will provide investments, access to Azure Cloud computing, and collaboration opportunities with Merck scientists. Applications are now open for 12 spots in the first cohort, with a focus on artificial intelligence (AI) and machine learning (ML) technologies. The initiative will be located in Newark, NJ, and Cambridge, MA, collaborating with the New Jersey Innovation Institute and supported by notable venture funds.
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