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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) 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%).
Merck (NYSE: MRK) is halting the development of its COVID-19 vaccine candidates, V590 and V591, after finding that their immune response was less effective than those of other vaccines. Instead, Merck will focus on advancing therapeutic candidates MK-4482 and MK-7110, which aim to treat COVID-19. The company plans to record a charge in Q4 2020 due to this decision, affecting GAAP results. Meanwhile, MK-7110 has shown promising Phase 3 results, while MK-4482 is undergoing Phase 2/3 trials. Merck remains committed to ongoing SARS-CoV-2 research and enhancing pandemic-response capabilities.
Merck (NYSE:MRK) has received FDA approval for VERQUVO (vericiguat), a soluble guanylate cyclase stimulator, aimed at reducing cardiovascular death and heart failure hospitalization for adults post-heart failure hospitalization or IV diuretics. This is the first treatment specifically approved for this patient group, based on VICTORIA trial data involving 5,050 patients. VERQUVO demonstrated a 4.2% reduction in annualized absolute risk compared to placebo. The drug comes with a boxed warning against use in pregnant women due to potential fetal harm.
Merck (NYSE: MRK) announced the FDA's acceptance of its Biologics License Application (BLA) for V114, a 15-valent pneumococcal conjugate vaccine aimed at preventing invasive pneumococcal disease in adults. The FDA has set a target action date of July 18, 2021, for this priority review. V114 offers protection against serotypes 22F and 33F, which are not covered by existing vaccines. This application is supported by robust clinical studies, including Phase 2 and Phase 3, demonstrating its efficacy in diverse adult populations.
Merck (NYSE: MRK) will host its fourth-quarter and full-year 2020 sales and earnings conference call on Feb. 4 at 8:00 a.m. EST. Executives will discuss the company's performance during the quarter. Investors and the general public can access a live audio webcast via Merck's website. A replay, along with financial disclosures, will also be available online. Merck has a long-standing commitment to advancing healthcare, focusing on innovative medicines and vaccines for critical diseases.
Merck (NYSE: MRK) will participate in the 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021, at 4:30 p.m. EST. Key executives, including Kenneth C. Frazier, Robert Davis, and Dr. Dean Li, will present during the event. A live video webcast will be available for investors, analysts, and the public at this link. Merck has a long-standing commitment to advancing healthcare through innovative medicines and vaccines, focusing on critical diseases like cancer and infectious diseases.
AstraZeneca and Merck announced the approval of LYNPARZA in Japan for treating advanced ovarian, prostate, and pancreatic cancer. These approvals allow for maintenance treatment after first-line chemotherapy for homologous recombination repair deficient (HRD) ovarian cancer, treatment for BRCA gene-mutated metastatic prostate cancer, and maintenance post-platinum chemotherapy for unresectable pancreatic cancer. The decisions were based on Phase 3 trial results, emphasizing the importance of biomarker testing in personalizing cancer treatment.
Merck (NYSE: MRK) has reached an agreement with the U.S. Government to develop and manufacture MK-7110, an investigational therapy for COVID-19, pending FDA approval. The deal is valued at approximately $356 million, aiming to supply 60,000-100,000 doses by June 30, 2021, as part of Operation Warp Speed. MK-7110 has shown promising results, with a 60% higher probability of clinical improvement in COVID-19 patients compared to placebo. The ongoing Phase 3 trial enrolled 243 patients, indicating robust efficacy for severe COVID-19 cases.