Welcome to our dedicated page for Merck & Co news (Ticker: MRK), a resource for investors and traders seeking the latest updates and insights on Merck & Co stock.
Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada, generates frequent news across human health, animal health and corporate finance. As a research-intensive biopharmaceutical company with more than a century of history developing medicines and vaccines, Merck regularly announces clinical trial milestones, regulatory decisions, business development transactions and capital markets activity.
Recent news highlights include oncology updates from Merck’s extensive KEYTRUDA program, such as positive Phase 3 data in muscle-invasive bladder cancer and new trials in non-small cell lung cancer using combinations like calderasib (MK-1084) with KEYTRUDA QLEX. The company also reports on progress in other therapeutic areas, including pulmonary arterial hypertension with WINREVAIR, Alzheimer’s disease candidates MK-2214 and MK-1167, and cardiovascular research with the oral PCSK9 inhibitor candidate enlicitide.
Investors following MRK news will also see announcements related to Merck Animal Health, such as the conditional U.S. FDA approval of EXZOLT CATTLE-CA1 for the prevention and treatment of New World screwworm larvae and the treatment and control of cattle fever tick, as well as updates on acquisitions like the planned merger with Cidara Therapeutics to add the influenza candidate CD388 to Merck’s respiratory portfolio.
Corporate and financial communications include quarterly earnings calls, participation in major healthcare conferences and disclosures about note offerings under the company’s shelf registration statement. This news page aggregates these developments so readers can review clinical, regulatory, strategic and financial updates related to Merck & Co., Inc. and its MRK stock in one place.
Merck (NYSE: MRK) will hold its first-quarter 2022 sales and earnings conference call on April 28 at 8:00 a.m. EDT. Executives will provide insights into the company's quarterly performance and future outlook. The event will be accessible to investors, journalists, and the public via a live audio webcast, with a replay and additional financial disclosures available later on their website.
Merck has a long-standing commitment to developing medicines and vaccines for serious diseases, emphasizing its role as a leading biopharmaceutical company.
Merck (NYSE: MRK) announced a significant expansion of its cardiopulmonary pipeline and portfolio, tripling its size through clinical trial advancements and business development deals in the past year. The company anticipates eight potential approvals in its cardiovascular portfolio by 2030, with initial launches expected between 2024 and 2028. The overall peak commercial revenue opportunity for this portfolio is projected to exceed $10 billion by the mid-2030s.
Merck (NYSE: MRK) has reaffirmed its commitment to enhance access to HPV vaccines by significantly investing in manufacturing. The company expanded its Elkton, VA facility by 120,000 square feet, creating 150 jobs, to meet the rising global demand for HPV vaccines. Merck aims to provide 91.5 million doses to Gavi-supported countries from 2021-2025. Having committed over $1 billion for capacity expansion, Merck expects its supply to double between 2020 and 2023 as new facilities come online.
Merck (NYSE: MRK) announced an extension of the Prescription Drug User Fee Act (PDUFA) date for their Pneumococcal 15-valent Conjugate Vaccine, VAXNEUVANCE, to July 1, 2022. The FDA requested additional analyses of data from pediatric studies, which Merck has provided. The vaccine is aimed at infants and children aged 6 weeks to 17 years for preventing invasive pneumococcal disease. Previously, VAXNEUVANCE received Priority Review from the FDA, and the company remains confident in the strength of its pediatric data.
Merck (NYSE: MRK) and Ridgeback Biotherapeutics presented data on LAGEVRIO (molnupiravir) at the 2022 European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). The Phase 3 MOVe-OUT trial results showed that LAGEVRIO led to the rapid elimination of infectious SARS-CoV-2 in patients with initial viral infection. At Days 3, 5, and 10, 0.0% of patients on LAGEVRIO had detectable infectious virus compared to 21.8% and 2.2% in the placebo group. These findings suggest LAGEVRIO's potential in treating mild to moderate COVID-19 among at-risk adults.
Eikon Therapeutics has appointed Kenneth C. Frazier as its first independent director, effective April 1, 2022. Frazier, the former CEO of Merck (NYSE:MRK) and current director at Exxon Mobil Corporation (NYSE:XOM), brings extensive pharmaceutical industry expertise. His leadership at Merck was marked by the advancement of numerous significant medicines. Eikon's CEO, Roger M. Perlmutter, expressed that Frazier's knowledge and advocacy for social justice will greatly benefit the company's mission in drug discovery and development.
Organon (NYSE: OGN) and Daré Bioscience (NASDAQ: DARE) have entered an agreement for Organon to license global rights to XACIATO, an FDA-approved treatment for bacterial vaginosis (BV) affecting an estimated 21 million U.S. women. The deal includes a $10 million upfront payment to Daré, potential milestone payments of up to $182.5 million, and tiered royalties on net sales. XACIATO is expected to be commercially available in the U.S. in Q4 2022, pending regulatory review. This collaboration aligns with Organon's strategy to enhance women's healthcare options.
Merck (NYSE: MRK) announced that the European Medicines Agency’s CHMP has recommended approval of KEYTRUDA for treating certain cancers with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors. This includes patients with unresectable or metastatic colorectal, gastric, small intestine, and biliary cancers, as well as advanced or recurrent endometrial carcinoma after previous therapies. The recommendation is based on successful results from the Phase 2 KEYNOTE-158 and KEYNOTE-164 trials, supporting its use as a monotherapy.
Merck (NYSE: MRK) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of KEYTRUDA combined with chemotherapy for treating persistent, recurrent, or metastatic cervical cancer in adults with PD-L1 expressing tumors (CPS ≥1). This recommendation follows the Phase 3 KEYNOTE-826 trial, which showed significant improvements in overall survival (HR=0.64) and progression-free survival (HR=0.62), with a 68% objective response rate compared to 50% for chemotherapy alone. A final decision from the European Commission is anticipated in Q2 2022.
Merck (NYSE: MRK) announced the retirement of Dr. Roy D. Baynes, Chief Medical Officer, effective July, with Dr. Eliav Barr succeeding him on April 1, 2022. Dr. Baynes has significantly contributed to Merck's oncology leadership, notably through the development of KEYTRUDA. Under Dr. Barr, who has over two decades with Merck, the company aims to continue advancements in clinical development, particularly in oncology and vaccines. This leadership transition aims to ensure ongoing growth and innovation in Merck’s pipeline.
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