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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 LYNPARZA as the first PARP inhibitor for adjuvant treatment in adults with germline BRCA mutations and HER2-negative early breast cancer, based on the Phase 3 OlympiA trial results. LYNPARZA showed a 42% reduction in the risk of invasive disease recurrence and a 32% reduction in mortality compared to placebo. AstraZeneca will receive a $75 million payment from Merck due to this approval. This milestone indicates a shift in treatment options for high-risk patients, aiming to decrease recurrence rates.
Merck (NYSE: MRK) and Eisai announced that the Phase 3 LEAP-002 trial of KEYTRUDA combined with LENVIMA did not meet its primary endpoints for overall survival (OS) and progression-free survival (PFS) in unresectable hepatocellular carcinoma (uHCC). Although there were trends indicating potential benefits of the combination over LENVIMA monotherapy, results lacked statistical significance. The safety profile matched previous data. Merck and Eisai will showcase findings at a medical conference while continuing research on this combination across various cancers.
Merck (NYSE: MRK) announced that the Phase 3 KEYNOTE-921 trial for KEYTRUDA combined with chemotherapy (docetaxel) failed to meet its primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC). Despite modest trends favoring the combination, results lacked statistical significance. The safety profile of KEYTRUDA remained consistent with previous studies. Merck continues its commitment to developing new treatments for prostate cancer through various ongoing trials.
Merck reported robust financial performance for Q2 2022, with worldwide sales of $14.6 billion, a 28% increase from Q2 2021. Key drivers included KEYTRUDA sales rising 26% to $5.3 billion and GARDASIL growing 36% to $1.7 billion. Non-GAAP EPS improved to $1.87. The company received FDA approval for VAXNEUVANCE, and expanded indications for KEYTRUDA. Merck raised its full-year sales guidance to between $57.5 billion and $58.5 billion, reflecting a growth expectation of 18% to 20% despite foreign exchange impacts.
Merck (NYSE: MRK) announced a quarterly dividend of $0.69 per share for Q4 2022. The payment is scheduled for October 7, 2022, to shareholders on record as of September 15, 2022. This dividend declaration reflects the company's commitment to returning value to its shareholders.
Merck aims to lead in biopharmaceuticals while promoting diversity and sustainability in its operations. The company recognizes various risks and uncertainties affecting its performance, including market conditions and regulatory challenges.
Merck (NYSE: MRK) announced that its Phase 3 KEYNOTE-412 trial of KEYTRUDA® (pembrolizumab) combined with chemoradiation therapy for unresected locally advanced head and neck squamous cell carcinoma (HNSCC) failed to meet its primary endpoint of event-free survival (EFS). While the trial showed some improvement in EFS compared to placebo, it did not achieve statistical significance. Despite this setback, Merck remains committed to exploring KEYTRUDA regimens for HNSCC in earlier disease stages, with plans to present detailed results at a medical meeting.
Merck (NYSE: MRK) has entered a global agreement with Orion for the development and commercialization of the investigational drug ODM-208, designed to inhibit CYP11A1, crucial in steroid production. Merck will pay Orion USD 290 million upfront, expensed in Q3 2022. Orion will recognize about EUR 220 million as income upon signing. The deal allows for future milestone payments and royalties on sales if ODM-208 is approved, presenting a significant opportunity for both companies in tackling metastatic castration-resistant prostate cancer.
Merck (NYSE: MRK) has launched the Merck Digital Sciences Studio (MDSS) aimed at fostering innovation in drug discovery by supporting early-stage biomedical startups. The MDSS will provide investments, access to Azure Cloud computing, and collaboration opportunities with Merck scientists. Applications are now open for 12 spots in the first cohort, with a focus on artificial intelligence (AI) and machine learning (ML) technologies. The initiative will be located in Newark, NJ, and Cambridge, MA, collaborating with the New Jersey Innovation Institute and supported by notable venture funds.
Merck (NYSE: MRK) will conduct its second-quarter 2022 sales and earnings conference call on July 28 at 8:00 a.m. ET. Company executives will present an overview of Merck's performance for the quarter and its outlook, accessible via a live audio webcast. The call can be joined by dialing designated numbers for the USA and international participants. A replay will be available on Merck's website along with supplemental disclosures. For over 130 years, Merck has been a leader in biopharmaceuticals, advancing health solutions globally.
AstraZeneca and Merck announced a positive recommendation from the European Medicines Agency for LYNPARZA in treating high-risk early breast cancer with gBRCA mutations. This follows the Phase 3 OlympiA trial, showing LYNPARZA improved invasive disease-free survival by 42% and overall survival by 32% compared to placebo. With breast cancer affecting 2.3 million globally in 2020, this treatment could significantly impact outcomes for HER2-negative patients in Europe. The drug is already approved in the U.S., EU, and Japan for various BRCA-related cancers.