Merck & Co Stock Price, News & Analysis

Merck (NYSE:MRK) announced multiple agreements to boost manufacturing capacity for SARS-CoV-2/COVID-19 vaccines and medicines, receiving up to $268.8 million in funding from BARDA. This funding will support adapting existing facilities for vaccine and medicine production. Additionally, Merck will collaborate with Janssen Pharmaceuticals to produce components of its COVID-19 vaccine. Merck plans substantial capital investments exceeding $20 billion through 2024 to enhance its global vaccine manufacturing capabilities.

Merck (NYSE: MRK) announced the fifth round of grants in its Merck for Mothers Global Grants program, aimed at reducing maternal mortality in critical regions. Launched in 2011, this initiative has supported over 60 projects globally, benefiting 3.5 million women and training 60,000 healthcare workers. The current grantees will implement high-impact activities across Asia Pacific, Europe, Africa, the Middle East, and Latin America, promoting health equity and improving maternal health services.

Merck (NYSE: MRK) announced the voluntary withdrawal of the U.S. indication for KEYTRUDA (pembrolizumab) in treating metastatic small cell lung cancer (SCLC) post-chemotherapy. This decision, made in consultation with the FDA, is part of a broader industry review of accelerated approvals. The withdrawal does not impact other KEYTRUDA indications. The accelerated approval, granted in June 2019, was based on tumor response data, but the confirmatory trial did not show statistical significance in overall survival. Merck is notifying healthcare providers and suggests patients discuss treatment options.

Merck (NYSE: MRK) announced that the FDA has accepted its New Drug Application (NDA) for gefapixant, a selective P2X3 receptor antagonist, aimed at treating refractory chronic cough (RCC) and unexplained chronic cough (UCC) in adults. The FDA has set a target action date of December 21, 2021. This application is based on results from the COUGH-1 and COUGH-2 clinical trials, which include over 2,000 patients. If approved, gefapixant would become the first medication specifically indicated for these conditions, addressing a significant unmet medical need.

Merck Animal Health, a division of Merck & Co. (NYSE: MRK), has completed the acquisition of Poultry Sense Ltd., an innovator in poultry health monitoring solutions. This acquisition aims to enhance Merck's technology portfolio to improve animal well-being and productivity in the poultry industry. Poultry Sense's technology allows real-time tracking of health indicators through wireless sensors, facilitating earlier illness detection and better farm management. Specific financial terms were not disclosed. This move aligns with Merck's strategy to expand its digital capabilities in animal health.

Merck (NYSE: MRK) has announced its agreement to acquire Pandion Therapeutics (Nasdaq: PAND) for $60 per share, totaling approximately $1.85 billion. The acquisition aims to enhance Merck's portfolio in autoimmune disease therapeutics, leveraging Pandion's TALON technology and its lead candidate, PT101. PT101 has completed a Phase 1a clinical trial focusing on safety and tolerability, showing promise in treating autoimmune diseases. The transaction is expected to close in the first half of 2021, pending regulatory approvals and other customary conditions.

Merck (NYSE: MRK) announced that Frank Clyburn, Executive Vice President and Chief Commercial Officer, will participate in the Cowen 41st Annual Health Care Conference on March 3, 2021, at 1:20 p.m. EST. A live video webcast of the presentation will be available to investors, analysts, media, and the public. For over 130 years, Merck has been committed to advancing healthcare through innovative medicines and vaccines. The company focuses on addressing various diseases and improving population health through partnerships and policies.

AstraZeneca and Merck (MRK) announced that their Phase 3 OlympiA trial for LYNPARZA will proceed to early primary analysis following an Independent Data Monitoring Committee (IDMC) recommendation. The trial crossed the superiority boundary for the invasive disease-free survival (iDFS) endpoint versus placebo in patients with germline BRCA-mutated, HER2-negative breast cancer. Approximately 2.3 million women were diagnosed with breast cancer in 2020, with 5% having BRCA mutations. The trial aims to assess further secondary endpoints of overall survival and distant disease-free survival.

Merck (MRK) and Eisai presented new data from the Phase 3 CLEAR study for advanced renal cell carcinoma (RCC) at the 2021 ASCO GU. KEYTRUDA plus LENVIMA showed significant improvements in progression-free survival (PFS) and overall survival (OS) compared to sunitinib, with PFS of 23.9 months and a 34% reduction in death risk. The objective response rate (ORR) reached 71%. LENVIMA plus everolimus also improved PFS but did not enhance OS compared to sunitinib. These results may shape future RCC treatment options.