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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 (NYSE: MRK) announced a new systematic literature review published in the Expert Review of Vaccines, detailing the global effectiveness of the GARDASIL vaccine. Covering 138 studies from 23 countries, the review highlights significant reductions in high-grade cervical lesions and HPV infections among vaccinated populations. Key findings include a 73% reduction in CIN3+ lesions in females aged 14-17 and a 96% decrease in vaccine-type HPV infections. The review underscores the necessity of expanding vaccination efforts to combat HPV-related cancers globally.
Veeva Systems (NYSE: VEEV) has announced a ten-year strategic partnership with Merck (NYSE: MRK), building upon their existing 12-year collaboration. The agreement entails Merck adopting a Veeva-first approach for new software and data solutions, aimed at reducing operational costs and enhancing patient and healthcare professional experiences. Veeva will offer a strategic pricing model and seek Merck's input on product development. This partnership is designed to accelerate Merck's digital transformation and improve efficiency in utilizing Veeva’s integrated platform.
Merck (MRK) reported strong third-quarter 2022 results, with worldwide sales of $15.0 billion, a 14% increase year-over-year. Key drivers include KEYTRUDA sales rising 20% to $5.4 billion and GARDASIL growing 15% to $2.3 billion. Non-GAAP EPS for the quarter was $1.85, up 4% compared to last year. Despite positive momentum, GAAP EPS fell 29% to $1.28 due to increased costs related to collaborations and licensing agreements. The company raised its full-year sales outlook to between $58.5 billion and $59.0 billion, while lowering GAAP EPS expectations to $5.68-$5.73.
Merck (NYSE: MRK) announced the retirement of Kenneth C. Frazier after 30 years, effective November 30, 2022. He served as CEO from 2011 to 2021 and as chairman since 2011. The board has elected Robert M. Davis, currently CEO and president, as the new chairman, effective December 1, 2022. Frazier's tenure is marked by significant investments in research and product launches that have advanced global health initiatives. Davis's leadership is anticipated to build upon Frazier's legacy of purpose-driven leadership and commitment to stakeholders.
Merck (NYSE: MRK) announced that the European Commission approved an expanded indication for VAXNEUVANCE, a 15-valent pneumococcal conjugate vaccine. This approval allows active immunization for infants, children, and adolescents against diseases caused by Streptococcus pneumoniae. In total, VAXNEUVANCE is now available in all 27 EU Member States and three additional countries. Key studies involving approximately 8,400 participants demonstrated noninferior immune responses compared to existing vaccines. Merck aims to strengthen protection against pneumococcal disease in vulnerable populations.
Merck (NYSE: MRK) announced positive results from a Phase 3 trial of PREVYMIS (letermovir) for CMV prophylaxis in kidney transplant recipients. The trial demonstrated that PREVYMIS is non-inferior to the standard treatment, valganciclovir, with a **10.4%** incidence of CMV disease compared to **11.8%** for valganciclovir. Additionally, PREVYMIS exhibited significantly lower rates of myelotoxicity (26% vs. 64%) in patients. Merck plans to submit a supplemental new drug application to the FDA by year-end based on these findings.
Merck Animal Health has launched the Animo® GPS, a new smart device designed for tracking dog activity and behavior. This GPS-enabled monitor alerts pet owners within 20 seconds if their dog leaves its 'Safe Zone,' with real-time location updates every five seconds in 'Lost Dog Mode.' The device tracks various behaviors such as sleep quality and barking via a mobile app. Animo GPS boasts a battery life of up to 12 weeks and is fully water-resistant. This innovation aims to enhance pet safety and health monitoring for dog owners.
Merck (NYSE: MRK) has partnered with the Bill & Melinda Gates Medical Research Institute to license two preclinical antibacterial candidates, MK-7762 and MK-3854, aimed at treating tuberculosis (TB). The compounds, discovered through the TB Drug Accelerator initiative, show potent antibacterial activity against Mycobacterium tuberculosis. The Gates MRI will conduct further studies to assess their potential in affordable combination therapies that might shorten treatment durations, particularly for drug-resistant TB, which poses significant global health challenges.
Merck (NYSE: MRK) has been recognized in Fortune's 2022 Change the World list for its commitment to enhancing global access to its human papillomavirus (HPV) vaccines. This marks the third inclusion in five years, showcasing its positive social impact as part of its core business strategy. Key initiatives include a long-term partnership with UNICEF to deliver 91.5 million vaccine doses and over $2 billion invested in vaccine supply. Merck aims to advance health equity and improve lives worldwide, aligning its actions with its Environmental, Social, and Governance (ESG) strategy.
Merck (NYSE: MRK) has announced positive results from the pivotal Phase 3 STELLAR trial for sotatercept, aimed at treating pulmonary arterial hypertension (PAH). The trial achieved its primary endpoint, showing a significant improvement in 6-minute walk distance at 24 weeks. Notably, eight out of nine secondary outcomes met statistical significance, including improvements in clinical worsening events. Sotatercept's safety profile aligns with earlier studies. The results underscore sotatercept's potential to redefine PAH treatment, with plans for urgent regulatory applications.