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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) announced the presentation of data from six approved medicines and pipeline candidates targeting over 25 cancers at the 2022 ASCO Annual Meeting in Chicago from June 3-7. Highlights include findings from KEYTRUDA, WELIREG, LYNPARZA, and LENVIMA, alongside investigational therapies like favezelimab and MK-0482. Key data emphasize advancements in treatment for cancers such as melanoma, non-small cell lung cancer, and triple-negative breast cancer. An Oncology Investor Event will occur on June 7, providing insights into Merck's oncology strategy.
Organon reported first quarter 2022 revenue of $1,567 million, a 4% increase from the previous year. Net income from continuing operations was $348 million or $1.36 per diluted share, reflecting a 12% decline year-over-year. The company’s adjusted net income was $420 million or $1.65 per diluted share, down 7%. Organon continues to grow its women's health offerings and affirmed its full-year financial guidance. A quarterly dividend of $0.28 was declared, payable on June 16, 2022.
Merck (NYSE: MRK) announced that Executive Vice President and Chief Financial Officer Caroline Litchfield will take part in a fireside chat at the Bank of America Securities 2022 Healthcare Conference. This event is set for May 11 at 11:40 a.m. ET, and interested parties can listen live through the provided link.
With over 130 years of experience, Merck is committed to advancing health care through innovative medicines and vaccines. The company addresses serious diseases, including cancer and infectious diseases, aiming to enhance global health access.
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.