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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.
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.
Merck (NYSE: MRK) and Gilead announced discontinuation of the Phase 3 KEYNOTE-D46/EVOKE-03 study of Trodelvy plus KEYTRUDA versus KEYTRUDA alone in previously untreated metastatic NSCLC patients with PD-L1 TPS ≥50%.
The eDMC recommended stopping after PFS failed to reach statistical significance and OS is unlikely to do so; safety was consistent with known profiles and no new safety signals emerged.
Apotex announced the U.S. launch of sitagliptin tablets and sitagliptin and metformin hydrochloride tablets, both eligible for 180-day shared exclusivity. These generics are AB rated to Merck’s JANUVIA and JANUMET and are indicated as adjuncts to diet and exercise for adults with type 2 diabetes.
The sitagliptin product comes in 25 mg, 50 mg, and 100 mg strengths, while the combination product is offered in 50 mg/500 mg and 50 mg/1,000 mg strengths. Both medicines are distributed through U.S. wholesalers and distributors.
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced that chairman and CEO Robert M. Davis and Dr. Dean Y. Li, president of Merck Research Laboratories, will join a fireside chat at the Goldman Sachs 47th Annual Global Healthcare Conference.
The session is scheduled for Tuesday, June 9, 2026, at 11:20 a.m. ET, with a live audio webcast accessible to investors, analysts, media, and the general public via an online weblink.
Merck (NYSE:MRK) and Moderna reported 5-year follow-up data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial of intismeran autogene (mRNA-4157, V940) plus KEYTRUDA in high-risk stage III/IV melanoma after complete resection.
The combination reduced risk of recurrence or death by 49% and distant metastasis or death by 59% versus KEYTRUDA alone at a median 60.3-month follow-up, with a safety profile consistent with prior analyses.
Merck (NYSE: MRK) reported that the FDA granted Breakthrough Therapy designation to calderasib (MK-1084), an investigational oral KRAS G12C inhibitor, combined with KEYTRUDA for first-line treatment of advanced or metastatic KRAS G12C‑mutant NSCLC with PD‑L1 TPS ≥1%.
The designation is supported by positive Phase 1 KANDLELIT‑001 data and is accompanied by an extensive KANDLELIT Phase 3 program across NSCLC and CRC. Calderasib is being developed in collaboration with Taiho and Astex.
Merck (NYSE: MRK) announced that Dr. Marjorie Green, senior vice president and head of oncology, global clinical development at Merck Research Laboratories, will join a fireside chat at the Jefferies Global Healthcare Conference on June 4, 2026, at 10:30 a.m. ET.
A live audio webcast of the presentation will be available to investors, analysts, media, and the public via an online weblink.
Merck (NYSE: MRK) declared a third-quarter 2026 quarterly dividend of $0.85 per share on its common stock. The dividend will be paid on July 8, 2026 to shareholders of record as of the close of business on June 15, 2026.
Merck (NYSE:MRK) received a positive opinion from the EU CHMP for KEYTRUDA plus Padcev as perioperative treatment for adults with resectable muscle-invasive bladder cancer who are ineligible for cisplatin chemotherapy, including the subcutaneous KEYTRUDA SC formulation.
The Phase 3 KEYNOTE-905 trial showed the combination cut event-free survival risk by 60% (HR=0.40) and death risk by 50% (HR=0.50) versus surgery alone, with higher pathologic complete response (57.1% vs 8.6%). An EC decision on EU marketing authorization is expected by Q3 2026.
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