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 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.
Merck (MRK) and Eisai received U.S. FDA approval on September 25, 2026, for WELIREG plus LENVIMA in previously treated advanced kidney cancer.
The oral combination is approved for adults with advanced renal cell carcinoma with a clear cell component after a PD-1 or PD-L1 inhibitor. In the 747-patient Phase 3 LITESPARK-011 trial, median progression-free survival was 14.6 months with the combination versus 10.6 months with cabozantinib. The risk of progression or death was 26% lower (HR 0.74; p=0.001), and objective response rates were 53% versus 40% (p=0.0002). At final analysis, overall survival did not meet statistical significance.
Serious adverse reactions occurred in 54% of patients receiving the combination, and fatal adverse reactions in 5%. Adverse reactions led to permanent discontinuation of WELIREG in 17% and LENVIMA in 23%. WELIREG carries a boxed warning for embryo-fetal harm.
Merck (MRK) reported both remigromig doses met BRUNELLO’s primary vision endpoint versus ranibizumab at week 52 in diabetic macular edema.
In the pivotal Phase 2b/3 study, 0.5 mg and 0.8 mg remigromig each demonstrated non-inferiority to 0.5 mg ranibizumab for mean change from baseline in best-corrected visual acuity, a measure of vision with corrective lenses. Both doses were generally well tolerated, but the remigromig arms had higher rates of proliferative diabetic retinopathy, vitreous hemorrhage and treatment discontinuations due to adverse events than the ranibizumab arm.
Remigromig is an investigational antibody designed to activate the Wnt pathway. BRUNELLO is the first of two pivotal Phase 2b/3 studies of remigromig in this condition; the other, BAROLO, is ongoing. Further analyses of the safety findings are underway. Merck plans to discuss the BRUNELLO results with regulators.
Merck (MRK) received U.S. FDA approval on an updated WINREVAIR™ (sotatercept‑csrk) label to add Phase 3 HYPERION trial efficacy and safety data in adults recently diagnosed with pulmonary arterial hypertension (PAH).
In HYPERION (N=320), adding WINREVAIR to background therapy in WHO functional class II–III patients diagnosed within 12 months reduced the risk of first clinical worsening event by 76% versus placebo (hazard ratio 0.24; 95% CI, 0.14–0.41; p<0.0001). A first clinical worsening event occurred in 10.6% of WINREVAIR patients versus 36.9% on placebo. The updated label also details adverse reactions, including higher rates of epistaxis (31.9% vs 6.9%), telangiectasia (26.3% vs 11.3%) and increased hemoglobin (11.3% vs 1.3%).
Separately, new European Respiratory Society PAH guidelines give WINREVAIR a “strong” recommendation, with “high” certainty of evidence, as add‑on therapy for adults on background treatment who have not achieved low‑risk status.
Merck (MRK) received approval from Japan’s Ministry of Health, Labor and Welfare for KEYTRUDA QLEX / KEYJECT, a subcutaneous formulation of pembrolizumab with berahyaluronidase alfa, for all KEYTRUDA indications currently approved in Japan.
KEYJECT is the first and only subcutaneous immune checkpoint inhibitor in Japan and can be administered by a healthcare provider in about one minute every three weeks or two minutes every six weeks. Approval is supported by Phase 3 trial MK‑3475A‑D77 in treatment‑naïve metastatic NSCLC, which showed comparable pembrolizumab exposure, similar overall response rates (45% vs 42%) and no notable differences in PFS or OS versus intravenous KEYTRUDA, both given with chemotherapy every six weeks. Subcutaneous pembrolizumab formulations are already approved in the U.S. and EU for all KEYTRUDA indications in those regions.
Merck (MRK) received a positive opinion from the EMA’s CHMP recommending approval of KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) as perioperative (neoadjuvant and adjuvant) treatment for adults with resectable muscle-invasive bladder cancer (MIBC), including both cisplatin-eligible and cisplatin-ineligible patients.
The recommendation, which also covers subcutaneous KEYTRUDA SC / KEYTRUDA QLEX, will be reviewed by the European Commission, with a final decision expected by Q4 2026 for the EU, Iceland, Liechtenstein and Norway. The opinion is based on Phase 3 KEYNOTE-B15, where KEYTRUDA plus Padcev reduced risk of event-free survival events by 47% (HR 0.53) and risk of death by 35% (HR 0.65) versus neoadjuvant gemcitabine/cisplatin plus surgery, and improved pathologic complete response rate to 55.8% versus 32.5%. Prior EC approval already covers cisplatin-ineligible MIBC based on KEYNOTE-905.
Merck (MRK) launched Your Hive of Whole Health, a multi-year educational program to help people living with HIV build personalized support networks for whole person care. Unveiled at the 2026 U.S. Conference on HIV/AIDS in Anaheim, the initiative provides tools and resources to support physical, mental, emotional, and social well-being. The program, created with community advisors and featuring advocate Debbie Allen, encourages individuals to identify and nurture their own “Hive” of caregivers, peers, and supporters, with more information available at HiveofWholeHealth.com.