Welcome to our dedicated page for Merck & Co. news (Ticker: MRK), a resource for investors and traders seeking the latest updates and insights on Merck & Co. stock.
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.
Merck (NYSE: MRK) announced positive topline results from the pivotal PNEU-PED (V114-029) study, evaluating the safety and immunogenicity of VAXNEUVANCE, a 15-valent pneumococcal conjugate vaccine, in infants aged 42-90 days. The study showed that VAXNEUVANCE had a safety profile comparable to PCV13, meeting primary endpoints for immunogenicity after 3 and 4 doses. Additionally, VAXNEUVANCE demonstrated superior immune responses for specific serotypes. The Phase 3 PNEU-LINK study also confirmed the vaccine's favorable safety profile, with full results to be shared at a scientific congress.
Merck (NYSE: MRK) announced the resignation of Leslie A. Brun, its independent lead director, effective August 19, 2021. Brun is stepping down to become chairman and CEO of Ariel Alternatives, a private equity initiative focused on scaling minority-owned businesses as tier 1 suppliers to Fortune 500 companies. Merck is considering an investment in Ariel Alternatives. CEO Rob Davis acknowledged Brun's contributions and expressed support for his new role. The company plans to appoint a new independent lead director soon.
Merck (NYSE: MRK) has received FDA approval for WELIREG, an oral HIF-2α inhibitor, to treat adult patients with von Hippel-Lindau (VHL) disease requiring therapy for associated renal cell carcinoma (RCC), central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors (pNET). This approval marks WELIREG as the first systemic therapy for certain VHL-associated tumors in the U.S. The treatment showed a significant overall response rate (ORR) of 49% in RCC patients and is vital for addressing an unmet medical need.
Merck and Eisai announced FDA approval for the combination of KEYTRUDA and LENVIMA as a first-line treatment for advanced renal cell carcinoma (RCC). This decision is based on results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, which showed significant improvements in progression-free survival (PFS) and overall survival (OS) compared to sunitinib. KEYTRUDA plus LENVIMA reduced disease progression or death by 61%, with median PFS of 23.9 months versus 9.2 months for sunitinib. 71% of patients achieved confirmed objective response rate, indicating strong efficacy for this cancer therapy.
Merck (NYSE: MRK) announced that the FDA has accepted its supplemental Biologics License Application for KEYTRUDA, targeting advanced endometrial carcinoma with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) characteristics. This application stems from data from KEYNOTE-158, which will be discussed at the upcoming ESMO Congress. The FDA's target action date is March 28, 2022. KEYTRUDA has previously received accelerated approval for similar cancer indications and is part of Merck's expanding oncology portfolio, aimed at addressing challenging women's cancers.
Merck (NYSE: MRK) announced that the FDA has accepted its supplemental Biologics License Application for KEYTRUDA, its anti-PD-1 therapy, for the adjuvant treatment of renal cell carcinoma (RCC) patients at high risk of recurrence post-nephrectomy. This priority review is based on pivotal Phase 3 KEYNOTE-564 trial data, showing significant improvement in disease-free survival compared to placebo. The PDUFA target action date is set for December 10, 2021. Merck continues to explore KEYTRUDA across various settings in RCC, with over 20 clinical studies involving more than 4,000 patients globally.
Merck (NYSE: MRK) announced that its Phase 3 KEYNOTE-716 trial for KEYTRUDA, an anti-PD-1 therapy, successfully met its primary endpoint of recurrence-free survival (RFS) in high-risk stage II melanoma patients after complete surgical resection. The interim analysis showed significant RFS improvement compared to placebo, with no new safety concerns reported. The FDA has accepted a supplemental Biologics License Application for KEYTRUDA in this indication, granting it Priority Review with a target action date of December 4, 2021. This marks a critical step in advancing melanoma treatment.
Merck (NYSE: MRK) announced the appointment of Cristal N. Downing as chief communications & public affairs officer, effective August 16, 2021. This new role within the Executive Team emphasizes enhanced communication strategies. CEO Rob Davis praised Downing's transformational leadership and experience in biopharmaceuticals, highlighting her previous role at Johnson & Johnson, where she led communication strategies and health equity initiatives. The company aims to strengthen its strategic impact and continue delivering essential innovations amid a growing focus on biopharmaceutical advancement.
Merck (NYSE: MRK) reported strong Q2 2021 results, with sales rising 22% to $11.4 billion. Non-GAAP EPS increased by 28% to $1.31, while GAAP EPS fell 48% to $0.48, impacted by a $1.7 billion charge for Pandion acquisition. KEYTRUDA sales were a highlight, growing 23% to $4.2 billion. Regulatory approvals for KEYTRUDA and Lynparza were announced, enhancing their oncology portfolio. Full-year guidance projects revenue between $46.4 and $47.4 billion, with an EPS range of $4.24 to $4.34. COVID-19's impact is expected to wane.
Merck (NYSE: MRK) announced a quarterly dividend of $0.65 per share for Q4 2021, payable on October 7, 2021 to shareholders of record on September 15, 2021. This decision reflects the company's ongoing commitment to returning value to shareholders while maintaining its focus on innovation in various therapeutic areas, including cancer and infectious diseases. Merck has been a leader in the biopharmaceutical industry for over 130 years, dedicated to improving lives through its medicines and vaccines.
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