Welcome to our dedicated page for Merck & news (Ticker: MRK), a resource for investors and traders seeking the latest updates and insights on Merck & stock.
Merck & Co., Inc. reports news across a global pharmaceutical business known as MSD outside the United States and Canada. Company updates center on human health products for areas such as oncology, cardiometabolic disease and infections; vaccines including Gardasil; and Merck Animal Health medicines, devices and customer-support systems.
Recurring developments include FDA approvals, clinical and regulatory disclosures, research publications, pipeline additions, business development transactions, material agreements, capital-structure updates, governance matters, and operating and financial results. Recent themes include the approved HIV-1 regimen IDVYNSO, investigational programs such as enlicitide decanoate and TERN-701, technology partnerships for research, manufacturing and commercial functions, and animal health digital engagement initiatives.
Merck (MRK) and Eisai presented new data from the Phase 3 CLEAR study for advanced renal cell carcinoma (RCC) at the 2021 ASCO GU. KEYTRUDA plus LENVIMA showed significant improvements in progression-free survival (PFS) and overall survival (OS) compared to sunitinib, with PFS of 23.9 months and a 34% reduction in death risk. The objective response rate (ORR) reached 71%. LENVIMA plus everolimus also improved PFS but did not enhance OS compared to sunitinib. These results may shape future RCC treatment options.
Merck (NYSE: MRK) reported its financial results for Q4 and the full year 2020, achieving 5% growth in quarterly sales to $12.5 billion, and a 2% increase in annual sales to $48 billion. However, the company faced substantial challenges, including a $2.7 billion impairment charge related to an acquisition and a $1.6 billion intangible asset impairment for ZERBAXA. Non-GAAP EPS increased 14% in Q4 to $1.32, while GAAP EPS dropped to $(0.83). The impact of COVID-19 reduced revenue by approximately $2.5 billion for the year, primarily in human health.
Merck (NYSE: MRK) announced Kenneth C. Frazier will retire as CEO on June 30, 2021, transitioning to executive chairman. Robert M. Davis, currently CFO, will become CEO effective July 1, 2021, and president on April 1, 2021. The board expresses confidence in Davis’s ability to foster innovation and drive future growth. Frazier, who has led the company for over a decade, commended Davis's strategic leadership. Davis aims to maintain Merck's commitment to scientific innovation, particularly in developing essential medicines and vaccines amid the ongoing pandemic.
Merck (NYSE: MRK) has appointed Dr. Stephen L. Mayo to its Board of Directors, effective March 15, 2021. Dr. Mayo, a professor at Caltech and a member of the National Academy of Sciences, will stand for election at the Annual Meeting of Shareholders on May 25, 2021. His expertise in protein design is expected to enhance the board's scientific acumen, bringing valuable insights to the company's strategies. With Dr. Mayo's addition, the Merck board will consist of 14 members, bolstering its governance and decision-making capabilities.
Merck (NYSE: MRK) announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval for an expanded label of KEYTRUDA. This anti-PD-1 therapy is suggested as monotherapy for adult and pediatric patients over 3 years with relapsed or refractory classical Hodgkin lymphoma who have failed previous treatments, including autologous stem cell transplant. The recommendation is based on the KEYNOTE-204 trial, showing a 35% reduction in disease progression risk. A final decision from the European Commission is expected in Q1 2021.
Merck reported data from the Phase 3 KEYNOTE-598 study, evaluating the combination of KEYTRUDA and ipilimumab in patients with metastatic non-small cell lung cancer (NSCLC). Results showed no improvement in overall survival (OS) or progression-free survival (PFS) with the combination, and the addition of ipilimumab increased toxicity. The median OS was 21.4 months for the combination versus 21.9 months for monotherapy, while median PFS was 8.2 versus 8.4 months, respectively. The study was discontinued due to futility as per the Data Monitoring Committee's recommendation.
Merck (NYSE: MRK) has expanded its Safer Childbirth Cities initiative, offering funding for nine new city-based projects aimed at improving maternal health outcomes and addressing racial disparities. Launched in 2018, this initiative is part of Merck for Mothers, a $500 million global program. The selected projects will address health needs affected by COVID-19 and aim to increase maternal health equity through community-led solutions and support for women before, during, and after childbirth. The initiative responds to rising maternal mortality rates in the U.S., especially among Black and marginalized women.
Merck (NYSE: MRK) has declared a quarterly dividend of $0.65 per share for Q2 2021, payable on April 7, 2021, to shareholders of record by the close of business on March 15, 2021.
With a legacy of 130 years, Merck continues to innovate in biopharmaceuticals, addressing critical diseases like cancer and HIV, while enhancing healthcare access globally.
Merck (NYSE: MRK) announced interim data from its Phase 2a trial evaluating islatravir for pre-exposure prophylaxis (PrEP) in adults. The trial showed that both 60 mg and 120 mg once-monthly doses of islatravir met the pre-specified pharmacokinetics (PK) threshold for efficacy. Tolerability was acceptable, with mild to moderate adverse events reported. The ongoing study plans to transition to Phase 3 IMPOWER trials, aiming to broaden HIV prevention options for at-risk populations. As of now, 76.8% of participants have been dosed, suggesting a robust path forward for islatravir.
Merck (NYSE: MRK) announced that the European Commission has approved KEYTRUDA as a first-line monotherapy for adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This decision is based on the pivotal Phase 3 KEYNOTE-177 trial, which demonstrated a 40% reduction in disease progression risk compared to chemotherapy (HR=0.60) and a median progression-free survival of 16.5 months, more than double that of chemotherapy. KEYTRUDA showed a lower incidence of severe treatment-related adverse events (22% vs. 66%).