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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 final results from the Phase 3 KEYNOTE-394 trial at ASCO GI 2022, investigating KEYTRUDA plus best supportive care (BSC) for patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. The trial demonstrated a 21% reduction in the risk of death, with a median overall survival (OS) of 14.6 months for KEYTRUDA compared to 13.0 months for placebo. Key findings showed a 26% reduction in disease progression risk and an overall response rate (ORR) of 12.7%. However, treatment-related adverse events were higher in the KEYTRUDA group.
Merck Animal Health, part of Merck & Co. (NYSE:MRK), announced findings from its latest Veterinary Wellbeing Study, conducted with the AVMA. The survey, the third since 2017 and the first post-COVID-19, highlights increased mental health challenges among U.S. veterinarians and staff. Key findings include that 92% reported increased stress, with 88% citing student debt as a significant concern. Merck pledged $100,000 to support AVMA's mental health initiatives. The pandemic exacerbated staffing shortages, with serious psychological distress rising to 9.7% among veterinarians and 18.1% among support staff.
Merck (NYSE: MRK) has announced a significant partnership with UNICEF to supply up to 3 million courses of molnupiravir, its investigational COVID-19 antiviral, to low- and middle-income countries in the first half of 2022. This initiative aims to ensure equitable access to the treatment after regulatory approvals. The drug has been authorized in various countries, including the US, UK, and Japan. Merck has committed to manufacturing millions of doses and granting licenses to generic manufacturers to enhance affordability and availability in developing regions.
Merck (NYSE: MRK) announced positive results from the Phase 3 KEYNOTE-091 trial, showing that its anti-PD-1 therapy, KEYTRUDA, significantly improves disease-free survival (DFS) in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) post-surgery. The study met one of its dual primary endpoints, although the endpoint related to high PD-L1 expressers did not achieve statistical significance. The findings support KEYTRUDA’s potential in early-stage NSCLC treatment. Results are set for presentation at a medical meeting and regulatory submission.
Merck (NYSE: MRK) will hold its fourth-quarter and full-year 2021 sales and earnings conference call on February 3 at 8:00 a.m. EST. Company executives will outline Merck's performance and future outlook. Investors can access the live audio webcast on Merck’s website, where a replay will also be available. Merck has been committed to pioneering healthcare solutions for over 125 years, focusing on a wide range of diseases. The release includes forward-looking statements regarding potential industry challenges and regulatory impacts that could affect future performance.
Organon (NYSE: OGN) and Samsung Bioepis announced that the FDA has accepted the supplemental Biologics License Application (sBLA) for SB5, a citrate-free, high-concentration formulation of adalimumab, referencing HUMIRA®. The sBLA, submitted in October 2021, is based on clinical data comparing SB5's pharmacokinetics, safety, and immunogenicity between 100 mg/mL and 50 mg/mL formulations. SB5 is expected to launch in the U.S. on or after July 1, 2023, under a licensing agreement with AbbVie.
Merck (NYSE: MRK) has announced that CEO Robert M. Davis and Dr. Dean Y. Li, President of Merck Research Laboratories, will participate in the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022, at 5:15 p.m. ET. Investors and the public can view the live video webcast at their official investor relations website. Merck, a leader in biopharmaceuticals for over 125 years, focuses on developing medicines and vaccines for serious diseases. The company emphasizes its commitment to healthcare access and innovation.
Merck (MRK) and Eisai announced that the Japanese Ministry of Health has approved the combination of KEYTRUDA and LENVIMA for treating unresectable, advanced, or recurrent endometrial carcinoma after chemotherapy. This marks the first approval in Japan for this combination. The approval is based on the KEYNOTE-775/Study 309 trial, which showed a 38% reduction in the risk of death and a 44% decrease in disease progression risk compared to chemotherapy. This combination is already approved in the U.S. and Europe.
Merck (NYSE: MRK) and Ridgeback Biotherapeutics have received Special Approval for Emergency from Japan's Ministry of Health for molnupiravir, the world's first oral COVID-19 antiviral medication. This approval allows for swift access to treatment for SARS-CoV-2 infection, with the Japanese government purchasing 1.6 million courses of the drug. The approval is based on clinical data showing molnupiravir significantly reduces hospitalization and death rates among high-risk COVID-19 patients, making it a critical asset in combating the pandemic.
Merck (NYSE: MRK) and Ridgeback Biotherapeutics have announced that the FDA granted Emergency Use Authorization (EUA) for molnupiravir, an investigational oral antiviral for treating mild to moderate COVID-19 in high-risk adults. This milestone marks a significant step in the fight against COVID-19. Molnupiravir must be administered within five days of symptom onset. The companies plan to produce and distribute millions of courses globally, with commitments to equitable access. Concerns exist regarding the drug's use in pregnant individuals due to potential risks.