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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 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.
Merck (NYSE: MRK) and Eisai announced that the Phase 3 LITESPARK-011 trial of oral WELIREG (belzutifan) plus LENVIMA (lenvatinib) met the trial's primary endpoint of progression-free survival (PFS) at a pre-specified interim analysis versus cabozantinib in patients with advanced renal cell carcinoma whose disease progressed after anti-PD-1/L1 therapy.
The combination also showed a statistically significant improvement in the trial's key secondary endpoint objective response rate (ORR). A trend toward improved overall survival (OS) was observed but did not reach statistical significance at this interim analysis. Safety profiles were consistent with prior studies and no new safety signals were reported. Companies will discuss data with regulators and present results at a medical meeting.