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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) 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.
Merck (NYSE: MRK) announced that the FDA has accepted and granted priority review for a new sBLA for KEYTRUDA, used with chemotherapy for first-line treatment of locally advanced unresectable or metastatic esophageal and gastroesophageal junction carcinoma. This decision is based on pivotal Phase 3 KEYNOTE-590 trial data, which showed significant improvements in overall survival and progression-free survival compared to chemotherapy alone. The PDUFA target action date is April 13, 2021. Currently, KEYTRUDA is approved for second-line treatment in the U.S., China, and Japan.
Merck (NYSE: MRK) and Eisai announced that their Phase 3 trial of KEYTRUDA® (pembrolizumab) combined with LENVIMA® (lenvatinib) for advanced endometrial cancer met its primary endpoints: overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). The trial showed significant survival advantages over chemotherapy regimens in both the mismatch repair proficient and intention-to-treat populations. The companies plan to present results at medical meetings and submit applications for marketing authorization based on the findings.
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.