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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) will hold its second-quarter 2026 sales and earnings conference call with institutional investors and analysts at 9:00 a.m. ET on Tuesday, Aug. 4. A live audio webcast and replay, plus related earnings materials, will be available on www.merck.com.
Merck (NYSE: MRK) announced a new agreement with the ADAP Crisis Task Force to help state AIDS Drug Assistance Programs provide access to once-daily HIV treatment IDVYNSO (doravirine/islatravir) for eligible adults living with HIV.
IDVYNSO received FDA approval in April 2026 as a two-drug single-tablet regimen for virologically suppressed adults. Merck will also support access and affordability through The Merck Access Program, offering information on insurance coverage, out-of-pocket costs and co-pay assistance options.
The FDA approved KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), each with Trodelvy (sacituzumab govitecan-hziy), as first-line treatment for adults with PD-L1+ (CPS ≥10) unresectable locally advanced or metastatic triple‑negative breast cancer.
In Phase 3 KEYNOTE‑D19/ASCENT‑04, KEYTRUDA plus Trodelvy reduced risk of disease progression or death by 35% (HR 0.65) versus KEYTRUDA plus chemotherapy, with median PFS 11.2 vs 7.8 months and higher objective response rate (61% vs 55%). NCCN lists the regimen as a category 1 preferred first-line option for certain PD‑L1+ metastatic TNBC patients.
Merck (NYSE:MRK) received European Commission approval for KEYTRUDA plus Padcev as perioperative treatment (neoadjuvant and adjuvant) for adults with resectable muscle-invasive bladder cancer who are ineligible for cisplatin chemotherapy.
The Phase 3 KEYNOTE-905 trial showed a 60% reduction in event-free survival risk and 50% reduction in death risk versus surgery alone, with higher pathologic complete response rates. The approval covers all 27 EU states plus Iceland, Liechtenstein and Norway; launch timing depends on national reimbursement.
Merck (NYSE: MRK) reported positive topline Phase 3 results for tulisokibart (MK-7240) in the ATLAS-UC induction-only study in moderately to severely active ulcerative colitis. The trial met its primary endpoint of 12-week clinical remission by Modified Mayo Score and key secondary endpoints, with no safety concerns identified. Tulisokibart is the first anti-TL1A antibody to show Phase 3 clinical remission in this setting and is being studied across seven immune-mediated indications, including Phase 3 programs in UC and Crohn’s disease.
Merck (NYSE: MRK) received U.S. FDA approval for an expanded indication of CAPVAXIVE, its 21-valent pneumococcal conjugate vaccine, for children and adolescents aged 2–17 at increased risk who completed a primary pediatric PCV series.
The vaccine is now indicated to prevent invasive pneumococcal disease in these patients and adults, and pneumonia in adults, with the pneumonia indication granted under accelerated approval based on immune response data. A confirmatory trial is required, and no CAPVAXIVE efficacy studies have yet been completed.
Merck (NYSE:MRK), through Merck Animal Health, reported global survey results on canine allergic skin disease. Data from 1,710 dog owners and 1,413 veterinarians show high prevalence of itchy skin cases, treatment switching due to efficacy, safety and cost concerns, and a desire for rapid-onset, targeted, easier-to-administer antipruritic options, including for younger dogs and more affordable therapies.
Merck (NYSE:MRK) received FDA approval for KEYTRUDA and KEYTRUDA QLEX, each combined with WELIREG, as adjuvant treatment for adults with clear cell renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy, with or without metastasectomy.
Phase 3 LITESPARK-022 (1,841 patients) showed KEYTRUDA plus WELIREG cut the risk of disease recurrence, metastasis or death by 28% versus KEYTRUDA plus placebo (HR=0.72; p=0.0003), with 24‑month disease-free survival of 81% vs 74%. WELIREG carries a boxed warning for embryo‑fetal harm and can cause severe anemia and hypoxia.
Merck (NYSE:MRK), through Merck Animal Health, signed a definitive agreement to acquire biodevice innovator TARGAN for an undisclosed price.
The deal, expected to close in Q3 2026 pending regulatory approvals, would add TARGAN’s WingScan™ gender-identification system and high-speed ocular vaccine delivery technology for commercial poultry hatcheries worldwide.
Gilead and Merck (NYSE:MRK) reported positive topline Phase 3 results for once-weekly oral HIV regimen islatravir/lenacapavir (ISL/LEN). Both ISLEND-1 and ISLEND-2 met the Week 48 primary endpoint, showing statistical non-inferiority to daily BIKTARVY or standard of care, with generally comparable safety. The partners plan global regulatory filings.