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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.
Merck (NYSE: MRK) announced that the FDA has placed clinical holds on several investigational new drug applications for islatravir (MK-8591) due to decreases in lymphocyte and CD4+ T-cell counts observed during clinical studies. The holds affect oral and injectable formulations for HIV-1 treatment and prevention, halting further dosing and enrollment in several trials. Affected studies include Phase 3 trials for oral islatravir as pre-exposure prophylaxis (PrEP) in high-risk populations. Merck remains committed to addressing unmet needs in HIV care.
Organon (NYSE: OGN) has completed its acquisition of Forendo Pharma, enhancing its women's health pipeline with novel treatments for endometriosis and polycystic ovarian syndrome (PCOS). The transaction includes a $75 million upfront payment and potential total consideration of up to $954 million based on development and commercial milestones. Forendo's lead candidate, FOR-6219, is entering Phase 2 clinical trials and aims to offer a long-term treatment option for endometriosis, addressing significant unmet needs in women's health.
Merck (NYSE: MRK) has announced an additional $150 million commitment to its Merck for Mothers initiative, aiming to enhance maternal health globally. This investment builds upon a previous $500 million commitment made in 2011, targeting to support programs that will reach 25 million women by 2025, up from 13.1 million to date. The funding is crucial as the COVID-19 pandemic has hindered maternal care, particularly in high-need regions like India, Nigeria, and Kenya. A minimum of $15 million will also support initiatives addressing maternal health disparities in the U.S.
Merck (NYSE: MRK) has announced a pause in enrollment for the Phase 3 clinical studies IMPOWER 22 and IMPOWER 24, which evaluate the investigational drug islatravir for pre-exposure prophylaxis against HIV-1. This decision follows recommendations from an external data monitoring committee. However, participants already enrolled will continue receiving the study medication. Merck will enhance monitoring measures for participants during this period. The company remains committed to addressing unmet needs in HIV treatment and prevention.
Merck (NYSE: MRK) has received FDA approval for KEYTRUDA as an adjuvant treatment for pediatric and adult patients with completely resected stage IIB and IIC melanoma. This decision is based on KEYTRUDA's performance in the Phase 3 KEYNOTE-716 trial, demonstrating a 35% reduction in the risk of disease recurrence or death compared to placebo. After 14.4 months, 11% of patients treated with KEYTRUDA experienced recurrence, compared to 17% for the placebo group. This approval expands treatment options for patients at high risk of recurrence following surgery.
Merck (NYSE: MRK) announced that the FDA has accepted for Priority Review its supplemental Biologics License Application for VAXNEUVANCE, a 15-valent pneumococcal conjugate vaccine. This vaccine aims to prevent invasive pneumococcal disease in children aged 6 weeks to 17 years. The priority review indicates significant potential for improved safety and effectiveness. The FDA set a target action date of April 1, 2022. Clinical studies suggest it will broaden coverage against critical pneumococcal strains, addressing a considerable disease burden in children.
Merck (NYSE: MRK) and Ridgeback Biotherapeutics received a positive vote from the FDA's Antimicrobial Drugs Advisory Committee, recommending Emergency Use Authorization (EUA) for molnupiravir (MK-4482), an oral antiviral for treating mild to moderate COVID-19 in high-risk adults. The committee voted 13-10, asserting the benefits outweigh risks. Data from the MOVe-OUT study showed molnupiravir reduced hospitalization or death by approximately 50%. Merck is gearing up for production and aims for broad access to molnupiravir globally.
Merck (NYSE: MRK) has declared a quarterly dividend of
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