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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 that Jannie Oosthuizen, president, Human Health U.S., and Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, will participate in a fireside chat at the Jefferies Global Healthcare Conference in London on Thursday, Nov. 20, 2025 at 9:30 a.m. ET / 2:30 p.m. GMT. Investors, analysts, media and the public are invited to listen via a live audio webcast available at the provided weblink.
Merck (NYSE: MRK) announced Phase 3 CORALreef HeFH results showing once-daily oral enlicitide decanoate reduced LDL-C by 59.4% versus placebo at week 24 (95% CI: -65.6, -53.2; p<0.001) and by 61.5% versus placebo at one year (95% CI: -69.4, -53.7; p<0.001) in adults with heterozygous familial hypercholesterolemia on stable lipid therapy.
Secondary endpoints improved: non-HDL-C -53.0%, ApoB -49.1%, Lp(a) -27.5% (all p<0.001). 67.3% of treated patients achieved ≥50% LDL-C reduction and LDL-C <55 mg/dL at week 24 versus 1.0% placebo. Safety, serious AEs, and discontinuations were similar to placebo; adherence was high (~97%). Data presented at AHA 2025 and published in JAMA.
Merck (NYSE: MRK) reported Phase 3 CORALreef Lipids results showing investigational once-daily oral enlicitide decanoate produced a 55.8% LDL-C reduction at week 24 versus placebo (95% CI: -60.9, -50.7; p<0.001) and a 59.7% post-hoc reanalysis (95% CI: -62.3, -57.1; p<0.001). Reductions were sustained at one year: 47.6% primary (95% CI: -52.7, -42.5) and 52.4% post-hoc (95% CI: -55.1, -49.7), both p<0.001. Secondary endpoints fell significantly: non-HDL-C -53.4%, ApoB -50.3%, Lp(a) -28.2% at week 24. 67.5% of patients on enlicitide met the prespecified goal of ≥50% LDL-C reduction and LDL-C <55 mg/dL versus 1.2% on placebo. Overall safety and adverse event rates were reported as comparable to placebo, with high adherence (≈97%). Data were presented at AHA Scientific Sessions 2025 (Nov 8, 2025).
Merck (NYSE: MRK) entered a financing agreement with Blackstone Life Sciences to advance development of sacituzumab tirumotecan (sac-TMT), an investigational TROP2-targeting ADC. Blackstone will pay $700 million to fund a portion of 2026 development costs; the payment is non‑refundable, subject to termination provisions. Blackstone may receive low‑to‑mid single‑digit royalties on sac-TMT net sales if U.S. approval is obtained for first‑line triple‑negative breast cancer based on TroFuse‑011. Merck retains development, manufacturing, and commercialization control; the asset remains under the existing exclusive license with Kelun‑Biotech. Sac‑TMT is in 15 global Phase 3 trials across six tumor types.
Merck (NYSE: MRK) announced that Prometheus BioSciences, a Merck subsidiary, reached an agreement with Dr. Falk Pharma to discontinue their prior co-development/co-commercialization contract for MK-8690 (formerly PRA-052), an investigational anti-CD30 ligand monoclonal antibody in an early-stage clinical trial.
Under the deal Prometheus secures global rights to MK-8690; Falk will receive a $150 million upfront payment, may receive a development milestone payment, and is eligible for royalties in certain territories. Merck will record a $150 million pre-tax R&D charge (~$0.05 per share) in Q4 under both GAAP and non-GAAP.
Merck Foundation (MRK) launched the Collaborative for Equity in Cardiac Care, a $22 million initiative spanning five years to improve access to person-centered cardiovascular care in underserved U.S. communities, announced November 3, 2025.
Eleven organizations received grants to develop evidence-informed programs, and Johns Hopkins Center for Health Equity will serve as the National Program Office to provide technical assistance, peer learning, cross-site evaluation and results dissemination.
Summary not available.
Merck (NYSE: MRK) and Eisai reported Phase 3 LEAP-012 results in unresectable, non-metastatic hepatocellular carcinoma (HCC). At a pre-specified interim analysis, KEYTRUDA plus LENVIMA with TACE did not achieve statistical significance for overall survival (OS) versus TACE alone and the companies judged the likelihood of a future OS success to be low, prompting study closure.
The regimen met the other primary endpoint, progression-free survival (PFS), showing a statistically significant and clinically meaningful improvement; safety was consistent with prior studies. Results will be shared with investigators and the scientific community. Existing regulatory approvals are unaffected.
Merck (NYSE: MRK) announced that the European Commission approved KEYTRUDA (pembrolizumab) for adults with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) whose tumors express PD-L1 (CPS ≥1).
Approval covers KEYTRUDA as neoadjuvant monotherapy, continued as adjuvant with radiotherapy with or without cisplatin, then as monotherapy. The decision is based on Phase 3 KEYNOTE-689, where the KEYTRUDA perioperative regimen reduced risk of event-free survival (EFS) events by 30% (HR=0.70; 95% CI 0.55–0.89; p=0.00140) and doubled median EFS to 59.7 months versus 29.6 months vs comparator in PD-L1 CPS ≥1 patients. The approval follows CHMP positive recommendation and enables marketing across the 27 EU member states plus Iceland, Liechtenstein and Norway, with national reimbursement determining local availability.
Merck (NYSE: MRK) reported positive topline results from the Phase 3 LITESPARK-022 trial in clear cell renal cell carcinoma (RCC) following nephrectomy.
KEYTRUDA (pembrolizumab) plus WELIREG (belzutifan) demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) versus KEYTRUDA plus placebo in the adjuvant setting. The trial will continue to evaluate overall survival (OS), a key secondary endpoint. Merck said safety profiles for the combination were overall consistent with prior studies. Results will be presented at a future medical meeting and shared with regulatory authorities worldwide.