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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 (NYSE: MRK) announced an extension to the FDA's Prescription Drug User Fee Act (PDUFA) date by three months for the supplemental new drug application (sNDA) regarding LYNPARZA in combination with abiraterone and prednisone for treating metastatic castration-resistant prostate cancer (mCRPC). The extension aims to allow further review of the application, which is supported by the Phase 3 PROpel trial data. LYNPARZA is already approved for certain indications in the U.S. and EU, with ongoing regulatory reviews in additional countries.
Moderna and Merck announced positive results from the Phase 2b KEYNOTE-942 trial of mRNA-4157/V940 combined with KEYTRUDA in stage III/IV melanoma patients. The study showed a 44% reduction in the risk of disease recurrence or death compared to KEYTRUDA alone. This marks the first efficacy demonstration of an mRNA cancer treatment in a randomized trial. The companies plan to initiate a Phase 3 study and expand to other tumor types in 2023. Adverse events associated with mRNA-4157/V940 were consistent with previous studies, indicating manageable safety.
Merck (NYSE: MRK) has initiated a cash tender offer for all outstanding shares of Imago BioSciences (NASDAQ: IMGO) at $36 per share. This follows a definitive agreement announced on November 21, 2022, to acquire Imago. The tender offer is set to expire on January 10, 2023. Upon successful completion, Imago will merge into a Merck subsidiary and become a wholly-owned entity. The tender offer is subject to conditions, including the tender of a majority of Imago's shares and necessary regulatory approvals. Closing is expected in Q1 2023.
Merck (NYSE: MRK) announced the presentation of new data on investigational drugs, including favezelimab, zilovertamab vedotin, and nemtabrutinib, at the 64th American Society of Hematology (ASH) Annual Meeting from Dec. 10-13, 2022, in New Orleans and virtually. Key findings will involve nearly 40 abstracts showcasing advancements in blood cancer treatments, including new insights on KEYTRUDA (pembrolizumab). Dr. Gregory Lubiniecki emphasized Merck's commitment to enhancing the treatment landscape for blood cancer patients and the importance of their growing pipeline of therapies.
Merck (NYSE: MRK) announced a quarterly dividend of $0.73 per share for Q1 2023, to be paid on Jan. 9, 2023. This payment is for shareholders of record as of Dec. 15, 2022. Merck aims to leverage leading-edge science to improve lives globally and remains committed to research and development in the biopharmaceutical sector. The company emphasizes its dedication to sustainability and a diverse workforce, striving for a healthy future for all communities.
Merck (NYSE: MRK) announced positive topline results from the pivotal Phase 3 KEYNOTE-859 trial, where KEYTRUDA® (pembrolizumab) combined with chemotherapy significantly improved overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) for patients with HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma. The independent Data Monitoring Committee confirmed these statistically significant findings. No new safety concerns were identified. Results will be presented at future medical meetings and submitted for regulatory review.
Merck's potential approval for LYNPARZA in combination with abiraterone for treating metastatic castration-resistant prostate cancer (mCRPC) has gained a positive opinion from the European Medicines Agency's CHMP. The Phase 3 PROpel trial results showed a 34% reduction in disease progression or death compared to placebo, with median radiographic progression-free survival of 24.8 months. While the safety profile aligns with prior studies, 14% of patients discontinued treatment due to side effects, including anemia and fatigue.
Merck (NYSE: MRK) announced a new systematic literature review published in the Expert Review of Vaccines, detailing the global effectiveness of the GARDASIL vaccine. Covering 138 studies from 23 countries, the review highlights significant reductions in high-grade cervical lesions and HPV infections among vaccinated populations. Key findings include a 73% reduction in CIN3+ lesions in females aged 14-17 and a 96% decrease in vaccine-type HPV infections. The review underscores the necessity of expanding vaccination efforts to combat HPV-related cancers globally.
Veeva Systems (NYSE: VEEV) has announced a ten-year strategic partnership with Merck (NYSE: MRK), building upon their existing 12-year collaboration. The agreement entails Merck adopting a Veeva-first approach for new software and data solutions, aimed at reducing operational costs and enhancing patient and healthcare professional experiences. Veeva will offer a strategic pricing model and seek Merck's input on product development. This partnership is designed to accelerate Merck's digital transformation and improve efficiency in utilizing Veeva’s integrated platform.
Merck (MRK) reported strong third-quarter 2022 results, with worldwide sales of $15.0 billion, a 14% increase year-over-year. Key drivers include KEYTRUDA sales rising 20% to $5.4 billion and GARDASIL growing 15% to $2.3 billion. Non-GAAP EPS for the quarter was $1.85, up 4% compared to last year. Despite positive momentum, GAAP EPS fell 29% to $1.28 due to increased costs related to collaborations and licensing agreements. The company raised its full-year sales outlook to between $58.5 billion and $59.0 billion, while lowering GAAP EPS expectations to $5.68-$5.73.