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 (NYSE: MRK) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for KEYTRUDA, recommending its approval as a first-line treatment for adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This recommendation is based on the Phase 3 KEYNOTE-177 trial, which showed a significant improvement in progression-free survival compared to standard chemotherapy regimens. A final decision by the European Commission is anticipated in Q1 2021.
Merck (NYSE: MRK) announced that Robert M. Davis, CFO and Executive VP, will participate in a virtual fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on December 2, 2020, at 9:40 a.m. EST. Investors, analysts, and the public can listen to the live audio webcast via Merck's official site.
Merck has been dedicated to discovering medicines and vaccines for over 125 years, focusing on critical diseases including cancer and infectious diseases.
Summary not available.
Merck (NYSE: MRK) has submitted applications for its investigational 15-valent pneumococcal conjugate vaccine, V114, to both the FDA and EMA, targeting adults 18 and older. The applications are based on Phase 2 and Phase 3 clinical study results, addressing various adult populations, including those at increased risk. V114 aims to enhance protection against pneumococcal disease with serotypes not included in existing vaccines. Notably, it has previously received Breakthrough Therapy Designation from the FDA for certain age groups.
Merck (NYSE: MRK) has entered into a definitive agreement to acquire OncoImmune for $425 million in cash, with additional sales-based and regulatory milestone payments. The acquisition is bolstered by positive interim results from OncoImmune's Phase 3 trial for CD24Fc, a treatment for severe COVID-19, showing a 60% improvement in clinical status and over a 50% reduction in the risk of death. The deal is expected to close before the end of 2020, pending regulatory approvals. Merck will also invest $50 million in a new entity formed from OncoImmune's non-CD24Fc assets.
Merck (NYSE: MRK) has declared a quarterly dividend of $0.65 per share for Q1 2021. The payment date is set for January 8, 2021, with shareholders on record by December 15, 2020. This decision underscores Merck's commitment to returning income to shareholders while continuing its mission of advancing healthcare through innovative medicines and vaccines.
Merck has been a leader in the biopharmaceutical industry for over 125 years, focusing on significant health challenges including cancer and infectious diseases.
Merck (NYSE: MRK) has partnered with the Bill & Melinda Gates Foundation to fund a Phase 3 study, IMPOWER 22, to explore a once-monthly oral pre-exposure prophylaxis (PrEP) for HIV-1 in high-risk women and adolescent girls in sub-Saharan Africa. Islatravir, Merck’s investigational antiviral, will be tested for its safety and efficacy. With women representing nearly 60% of new infections in this region, this initiative aims to provide a significant preventive option and advance HIV science globally.
Merck (NYSE: MRK) announced FDA approval for KEYTRUDA in combination with chemotherapy for treating locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) with PD-L1 expression (CPS ≥10). This decision is based on the Phase 3 KEYNOTE-355 trial, demonstrating a 35% reduction in disease progression or death compared to chemotherapy alone. KEYTRUDA’s introduction offers a new option for TNBC patients, which affects 15-20% of breast cancer cases. However, this approval is under accelerated conditions pending further clinical evidence.
Merck (NYSE: MRK) and Eisai announced significant results from the Phase 3 KEYNOTE-581/CLEAR trial, demonstrating that KEYTRUDA® (pembrolizumab) combined with LENVIMA® (lenvatinib) provides superior progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) compared to sunitinib in first-line treatment of advanced renal cell carcinoma (RCC). The study also showed LENVIMA plus everolimus met PFS and ORR endpoints versus sunitinib. Both combinations exhibited safety profiles consistent with prior studies, with plans for regulatory submissions based on these findings.
Pappas Capital announced the acquisition of its portfolio company VelosBio Inc. by Merck (NYSE: MRK) for $2.75 billion in cash. VelosBio, a clinical-stage biopharmaceutical firm, develops innovative cancer therapies targeting ROR1. Pappas Capital has invested in VelosBio since 2018, including a $137 million Series B financing in July 2020. The acquisition aims to advance VelosBio's investigational drug, VLS-101, currently in clinical trials for treating hematologic malignancies and solid tumors. This strategic move marks a significant milestone for both Pappas Capital and VelosBio.