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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.
The European Commission has approved Merck's KEYTRUDA for treating microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumors in adults. This approval applies to various cancers, including colorectal, endometrial, gastric, small intestine, and biliary cancers, post previous therapies. KEYTRUDA's efficacy was supported by two Phase 2 trials, showing objective response rates of up to 56% across indications. This marks the second approval for KEYTRUDA related to MSI-H/dMMR biomarkers in Europe, expanding treatment options for patients facing advanced cancer.
Merck (NYSE: MRK) announces the European Commission's approval of KEYTRUDA for treating persistent, recurrent, or metastatic cervical cancer in patients with PD-L1 expressing tumors (CPS ≥1). This decision follows the Phase 3 KEYNOTE-826 trial, which showed a 36% reduction in death risk and improved overall survival (OS) and progression-free survival (PFS) with the KEYTRUDA regimen compared to traditional chemotherapy. The objective response rate (ORR) was 68% for KEYTRUDA versus 50% for chemotherapy. This marks the first immunotherapy regimens approved for this cancer type in Europe.
Merck (MRK) reported strong first-quarter 2022 results with worldwide sales of $15.9 billion, a 50% increase from Q1 2021, driven by effective commercial execution and recovery from COVID-19. Key product sales include KEYTRUDA at $4.8 billion (+23%) and LAGEVRIO with $3.2 billion in sales. GAAP EPS rose to $1.70 from $1.08, while non-GAAP EPS jumped to $2.14. Merck raised its full-year revenue guidance to between $56.9 billion and $58.1 billion, reflecting a growth of 17% to 19%. The company continues to advance its research pipeline with multiple regulatory approvals.
Merck (NYSE: MRK) announced a positive opinion from the European Medicines Agency's CHMP, recommending KEYTRUDA for adults with locally advanced, early-stage triple-negative breast cancer (TNBC) at high risk of recurrence. This recommendation stems from the pivotal KEYNOTE-522 trial, which demonstrated a 37% reduction in event risk with the KEYTRUDA regimen compared to chemotherapy-placebo. The European Commission will review this recommendation, with a decision expected in Q2 2022. If approved, this will be KEYTRUDA's second indication for TNBC in Europe.
Organon (NYSE: OGN) will release its Q1 2022 financial results on May 5, 2022, before an 8:30 a.m. EDT conference call. The call will be accessible via webcast on the company's website, with a replay available approximately two hours later. Analysts and investors must register in advance using conference ID# 6895016. Formed as a spin-off from Merck (NYSE: MRK), Organon focuses on women's health, boasting a diverse portfolio of over 60 medicines. The company aims to collaborate with biopharmaceutical innovators while maintaining strong cash flows for future growth.
Merck (NYSE: MRK) announced Joseph Romanelli will lead its Human Health International division, effective August 1, 2022. Reporting to CEO Robert M. Davis, Romanelli will oversee Merck's $22 billion international business and a team of 14,000 across 75 markets. He returns to Merck after serving as CEO of JiXing Pharmaceuticals, where he led the company's growth in China, Merck's second-largest market. Romanelli's extensive experience in strategic roles since joining Merck in 1996 positions him well to drive growth in the international sector.
Merck (MRK) announced that its investigational pneumococcal vaccine, V116, has received Breakthrough Therapy Designation from the FDA for preventing invasive pneumococcal disease in adults. This vaccine targets serotypes responsible for 85% of all cases in individuals aged 65 and over in the U.S. as of 2019. Phase 3 clinical trials are set to begin in 2022, following promising results from previous studies. The breakthrough designation aims to expedite development and review, suggesting significant potential for improved outcomes compared to existing vaccines.
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.