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) reported Phase 3 results showing sacituzumab tirumotecan reduced death risk by 32% versus chemotherapy in previously treated endometrial cancer.
The 776-patient TroFuse-005 trial enrolled patients previously treated with platinum-based chemotherapy and anti-PD-1/L1 immunotherapy. At a prespecified interim analysis, median overall survival was 19.0 versus 12.1 months, while median progression-free survival—time without disease progression or death—was 7.2 versus 3.9 months. Both primary endpoints improved statistically significantly. Tumor response rates were 35.1% versus 17.3%. Grade 3 or higher treatment-related adverse events occurred in 54.4% versus 41.4%; treatment-related deaths occurred in 0.8% in each arm. The FDA accepted the application for priority review, with a June 15, 2027 target action date. Sac-TMT is being developed with Kelun-Biotech.
Merck (MRK) and Moderna (MRNA) reported Phase 3 results showing intismeran plus KEYTRUDA reduced melanoma recurrence or death risk by 42%. INTerpath-001 enrolled 1,137 patients with completely resected stage IIB-IV melanoma. At median follow-up of 24.6 months, the combination also reduced distant metastasis or death risk by 38% versus KEYTRUDA alone. Two-year recurrence-free survival was 82.2% versus 70.0%; survival without distant metastasis was 88.5% versus 80.2%.
Efficacy was comparable during the first six months. After six months, a pre-specified sensitivity analysis showed 58% lower recurrence or death risk. Overall survival data remain immature, with a favorable trend observed. Grade 3–5 treatment-related adverse events occurred in 14.2% versus 13.4%; no new safety signals emerged. The companies are engaging regulators. Results will be presented at ESMO 2026 and have been accepted for publication in The New England Journal of Medicine.
Merck (NYSE: MRK) received European Commission approval for KEYTRUDA plus Padcev before and after surgery in adults with operable muscle-invasive bladder cancer.
The approval covers patients regardless of cisplatin eligibility and includes KEYTRUDA SC. It authorizes marketing across all 27 EU member states, Iceland, Liechtenstein and Norway. Country-level availability depends partly on national reimbursement procedures.
In the Phase 3 KEYNOTE-B15 trial, involving 808 cisplatin-eligible patients, the combination reduced the risk of disease progression, recurrence or death by 47% and the risk of death by 35% versus preoperative gemcitabine and cisplatin followed by surgery. Both improvements were statistically significant. Pathologic complete response was 55.8% versus 32.5%, also statistically significant. The FDA approved the perioperative combination for adults with muscle-invasive bladder cancer in July 2026.
Merck (MRK) announced that Paul J. Diaz will join its Board of Directors effective Nov. 1, 2026, bringing membership to 14.
Diaz, managing partner at Cressey & Company, will stand for election by shareholders in May 2027. He previously served as president and chief executive officer of Myriad Genetics and Kindred Healthcare.
Merck (MRK) will present first-time results from three pivotal oncology trials at ESMO 2026 in Madrid, Spain, on October 23-27.
INTerpath-001 showed improved recurrence-free and distant metastasis-free survival with investigational intismeran autogene plus KEYTRUDA versus KEYTRUDA alone after complete removal of stage IIB-IV melanoma. TroFuse-005 showed improved overall and progression-free survival with investigational sacituzumab tirumotecan in advanced or recurrent endometrial cancer after platinum chemotherapy and a PD-1 or PD-L1 inhibitor. KEYNOTE-C93 evaluates first-line KEYTRUDA alone in mismatch repair deficient advanced or recurrent endometrial cancer.
More than 90 additional abstracts cover more than 20 tumor types. Presentations include Phase 3 OptiTROP lung cancer studies and the final LITESPARK-011 kidney cancer analysis. Merck will hold an oncology investor event on October 26.
Merck (MRK) presented one-year BRUNELLO trial results showing both remigromig doses met the primary endpoint in adults with diabetic macular edema.
The pivotal Phase 2b/3 study showed non-inferiority, meaning vision gains met a prespecified margin versus monthly 0.5 mg ranibizumab. Best corrected visual acuity improved by 9.1 letters with remigromig 0.5 mg and 8.7 letters with 0.8 mg, versus 11.8 letters with ranibizumab. No secondary endpoint showed superiority. Proliferative diabetic retinopathy adverse events occurred in 6.7% and 6.1% of the respective remigromig groups versus 0.9%; adverse-event discontinuations were 4.9% and 4.5% versus 0.9%.
Results will be discussed with regulators. Remigromig remains under evaluation in BAROLO for diabetic macular edema and SUPER TUSCAN for wet age-related macular degeneration and retinal vein occlusion-related macular edema. Merck also has four pivotal trials underway for MK-8748.
Merck (NYSE: MRK) will hold its third-quarter 2026 sales and earnings conference call on Oct. 29 at 9:00 a.m. ET. Executives will review quarterly performance with institutional investors and analysts. A live audio webcast will be open to the public, and a replay, earnings release, supplemental financial disclosures and results slides will be available at www.merck.com.
Merck (MRK) announced that tulisokibart met the primary endpoint in a Phase 2b trial for moderate to severe hidradenitis suppurativa.
At week 16, HiSCR50, a response requiring at least a 50% reduction in abscesses and inflammatory nodules without increased abscess or draining tunnel counts, was achieved by 72% of high-dose and 64% of medium-dose patients versus 35% with placebo. Both regimens demonstrated superiority over placebo; the exploratory low-dose response was 52%. HiSCR75 responses were 41%, 40% and 29% for high, medium and low doses, respectively, versus 15% with placebo. Quality-of-life scores numerically improved versus placebo at high and medium doses, but not at low dose.
Adverse events occurred in 42.9%–52.4% of tulisokibart recipients versus 40.9% with placebo. No serious or opportunistic infections occurred. Merck plans to advance tulisokibart to Phase 3 in HS.
Merck (MRK) has closed an exclusive global license with SciBrunch Therapeutics for preclinical SPR2015, with a $400 million upfront payment.
Merck gained worldwide rights to develop, manufacture and commercialize the investigational oral KRAS G12D (ON) inhibitor. SciBrunch is eligible for payments tied to development, commercialization and other milestones across multiple indications. The transaction’s total potential value, including the upfront payment, is $2.13 billion. Merck will record a $400 million pre-tax charge, or approximately $0.13 per share, in third-quarter 2026 GAAP and non-GAAP results.
SPR2015 showed activity in KRAS G12D-mutant cell lines and antitumor effects in preclinical tumor models presented at the 2026 AACR Annual Meeting.
Merck (MRK) and Daiichi Sankyo’s U.S. application for ifinatamab deruxtecan in extensive-stage small cell lung cancer was voluntarily withdrawn.
The application sought accelerated approval for adults whose disease progressed on or after platinum-based chemotherapy. Following discussions with the FDA, the companies said the supporting data, including from the IDeate-Lung01 phase 2 trial, did not meet requirements for accelerated approval. IDeate-Lung01 enrolled 187 patients.
Enrollment continues in IDeate-Lung02, a phase 3 trial comparing the drug with physician-chosen chemotherapy after progression following one prior line of platinum-based chemotherapy. Ifinatamab deruxtecan remains investigational.