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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 Animal Health, a part of Merck & Co. (NYSE:MRK), has made a minority investment in LeeO Precision Farming B.V. and will distribute its digital swine traceability solution in selected markets. This cloud-based platform allows for real-time tracking of swine throughout their lifecycle, covering key life events from birth to transportation. The investment aims to enhance animal health solutions and traceability technology, fostering collaboration for better livestock management. LeeO's CEO expressed optimism about growth opportunities stemming from this partnership.
Merck (NYSE: MRK) announced that KEYTRUDA received four new approvals from Japan's Ministry of Health, Labor and Welfare, increasing its total to 23 approved uses across 13 cancer types. The new indications include:
- Neoadjuvant and adjuvant treatment for hormone receptor-negative breast cancer.
- Adjuvant treatment for renal cell carcinoma post-nephrectomy.
- Treatment for advanced cervical cancer.
- Adjuvant treatment for stage IIB and IIC melanoma.
These approvals aim to address rising cancer mortality rates in Japan, particularly for breast cancer.
Merck Animal Health has announced its acquisition of Vence, a leader in virtual fencing technology aimed at enhancing rotational grazing and livestock management. This initiative is set to expand Merck's portfolio of animal intelligence solutions, potentially increasing operational efficiencies for cattle producers. The deal is expected to close in the third quarter of 2022, reinforcing Merck's commitment to advancing animal health and well-being.
Merck (NYSE: MRK) and AstraZeneca announced that LYNPARZA has received approval in China as first-line maintenance treatment for patients with advanced ovarian cancer exhibiting homologous recombination deficiency (HRD)-positive status. The approval is based on the favorable outcomes of the Phase 3 PAOLA-1 trial showing significant progression-free survival (PFS) benefits. In China, ovarian cancer has a survival rate of ~39% among patients with advanced stages. This new treatment option is expected to enhance clinical outcomes for HRD-positive patients.
Merck (NYSE: MRK) achieved a significant legal victory as the U.S. District Court for the Northern District of West Virginia ruled in its favor in a patent infringement lawsuit against Viatris concerning sitagliptin, an active ingredient in JANUVIA and JANUMET. The court upheld the validity of two Merck patents, with expiration dates set for 2026 and 2029. Viatris aims to launch generic versions but faces challenges following this ruling. Merck has already settled agreements allowing generics to enter the market by May 2026. This decision is subject to appeal.
Merck (NYSE: MRK) announced the resumption of a Phase 2 study on an investigational weekly oral combination treatment of islatravir and lenacapavir for HIV-1, using a lower dose of islatravir. Merck will discontinue its monthly oral islatravir development for pre-exposure prophylaxis (PrEP) but plans to initiate a new Phase 3 clinical program for once-daily islatravir and doravirine. The FDA has approved this new approach, highlighting Merck's commitment to HIV treatment.
Merck (NYSE: MRK) has received a positive recommendation from the European Medicines Agency’s CHMP for its pneumococcal vaccine VAXNEUVANCE. The vaccine, which targets Streptococcus pneumoniae, is aimed at infants and children aged 6 weeks to under 18 years, complementing existing approvals for older populations. A final decision from the European Commission is anticipated by year-end 2023. Merck's commitment to combating pneumococcal disease continues, highlighting its focus on developing vaccines for various demographics against serious infections.
Seagen, Astellas, and Merck announced promising results from the phase 1b/2 EV-103 trial, showcasing a 64.5% confirmed objective response rate (ORR) in patients with unresectable locally advanced or metastatic urothelial cancer treated with enfortumab vedotin and pembrolizumab. The primary endpoint was met with significant responses including 10.5% complete responses. The median overall survival (OS) was 22.3 months. The trial highlights the potential of this combination therapy for patients ineligible for cisplatin chemotherapy. Discussions with regulatory authorities are planned.
Astellas, Seagen, and Merck announced significant findings from the phase 1b/2 EV-103 trial, highlighting a 64.5% confirmed objective response rate in unresectable advanced urothelial cancer patients treated with enfortumab vedotin and pembrolizumab. This combination demonstrated promising efficacy as a first-line treatment, with 10.5% achieving complete response. Additionally, median overall survival reached 22.3 months for the combination group. Adverse events mainly included skin reactions and neuropathy. The companies plan to discuss results with regulatory authorities and pursue further studies.
Merck (NYSE: MRK) announced promising five-year survival data for KEYTRUDA in treating metastatic non-small cell lung cancer (NSCLC). In KEYNOTE-189, KEYTRUDA plus chemotherapy achieved a five-year overall survival (OS) rate of 19.4%, significantly higher than 11.3% for chemotherapy alone. KEYNOTE-407 reported a five-year OS rate of 18.4% for KEYTRUDA plus chemotherapy versus 9.7% for chemotherapy alone. These results affirm KEYTRUDA's role as a first-line treatment, demonstrating improved overall survival and durable responses, significantly altering the treatment landscape for NSCLC.