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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.
AstraZeneca and Merck announced that LYNPARZA received conditional approval in China for treating adult patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed after new hormonal therapies. The approval is based on Phase 3 PROfound trial results, demonstrating a 78% reduction in disease progression and a 37% decrease in mortality risk with LYNPARZA compared to abiraterone or enzalutamide. The drug improves radiographic progression-free survival to 9.8 months versus 3.0 months. Approval continues pending further verification through ongoing trials.
Merck (NYSE: MRK) announced that its Phase 3 KEYNOTE-826 trial for KEYTRUDA in combination with platinum-based chemotherapy has met primary endpoints in treating persistent, recurrent, or metastatic cervical cancer. This regimen showed significant improvements in overall survival (OS) and progression-free survival (PFS) compared to standard treatments, marking a key advancement in first-line immunotherapy for cervical cancer. Results will be presented at a medical meeting and submitted for regulatory review. KEYTRUDA's safety was consistent with prior studies.
Merck (NYSE: MRK) has secured a procurement agreement with the U.S. government for approximately 1.7 million courses of its investigational oral antiviral drug, Molnupiravir, pending Emergency Use Authorization by the FDA. The deal amounts to $1.2 billion, with Merck expecting to have over 10 million courses available by the end of 2021. Molnupiravir is currently in a Phase 3 clinical trial for treating non-hospitalized COVID-19 patients. Merck also plans to submit applications for authorization in other countries and has partnered with generic manufacturers to enhance global access.
Merck (NYSE: MRK) announced that Dr. Dean Li, executive vice president and president of Merck Research Laboratories, will participate in a virtual fireside chat at the Guggenheim Biopharma Strategy Series on June 22, 2021, at 9:00 a.m. EDT. The discussion will focus on global strategy and innovation in the biopharma sector. Investors, analysts, and the public can access the live audio webcast via Merck's investor relations site at this link.
Merck has a rich history of 130 years, dedicated to innovating medicines and vaccines.
Merck (NYSE: MRK) has announced the establishment of the Kenneth C. Frazier Award for Maternal Health Equity, which will be granted annually to honor organizations dedicated to improving maternal health care quality. This initiative, part of Merck for Mothers, aligns with Merck’s mission to combat systemic health access barriers. Named after the CEO, the award aims to spotlight impactful organizations, with nominations due by July 30, 2021, and grants of up to $250,000 available. Merck for Mothers, a $500 million initiative, aims to enhance health equity globally.
Merck (NYSE: MRK) has signed a procurement agreement with the U.S. government for molnupiravir (MK-4482), an investigational COVID-19 therapy currently in Phase 3 trials. If authorized, Merck will provide approximately 1.7 million treatment courses for around $1.2 billion. The company aims to have over 10 million courses available by the end of 2021. Merck is also pursuing global availability through tiered pricing and licensing agreements in 104 low- and middle-income countries. The ongoing MOVe-OUT study may lead to an Emergency Use Authorization later in 2021.
Merck (MRK) and Eisai have shared new findings from the pivotal Phase 3 CLEAR/KEYNOTE-581 trial, evaluating KEYTRUDA combined with LENVIMA for advanced renal cell carcinoma (RCC). This analysis, presented at ASCO 2021, indicates improved health-related quality of life (HRQoL) for patients using KEYTRUDA and LENVIMA over sunitinib. Key results showed better scores in physical functioning and fatigue at a mean follow-up of 46 weeks. The findings support the combination as a potential first-line treatment option, with data currently under FDA review.
Merck announced pivotal Phase 3 KEYNOTE-564 trial results for KEYTRUDA, demonstrating a 32% reduction in disease recurrence or death risk in renal cell carcinoma (RCC) patients post-nephrectomy. The trial involved 994 patients, showing KEYTRUDA's two-year disease-free survival rate at 77.3% versus 68.1% for placebo. Adverse events were noted, with 18.9% experiencing grade 3-5 treatment-related issues. As the first immunotherapy illustrating clinical benefit in RCC adjuvant treatment, KEYTRUDA could set new care standards. Outcomes will be presented at the 2021 ASCO Annual Meeting.
AstraZeneca and Merck (NYSE: MRK) announced significant findings from the Phase 3 OlympiA trial for LYNPARZA, which showed a 42% reduction in the risk of invasive breast cancer recurrence in patients with germline BRCA1/2 mutations compared to placebo. The data, presented at the 2021 ASCO Annual Meeting and published in the New England Journal of Medicine, highlighted a 3-year iDFS rate of 85.9% for LYNPARZA versus 77.1% for placebo. Secondary results also indicated a 43% reduction in distant disease-free survival risk. The trial continues to assess overall survival.
Merck (NYSE: MRK) has successfully completed the spinoff of Organon & Co., creating an independent publicly traded company. This strategic move aims to enhance each entity's operational focus and financial profiles. Merck anticipates achieving approximately $1.5 billion in operating efficiencies over three years, with an estimated $500 million realized in 2021. The spinoff involved a $9 billion distribution from Organon to Merck shareholders. Organon will now trade under the symbol 'OGN' on the New York Stock Exchange, while Merck retains 'MRK'.