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 (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Daiichi Sankyo’s U.S. application for ifinatamab deruxtecan in extensive-stage small cell lung cancer was voluntarily withdrawn.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.
Perspective Therapeutics (CATX) announced a clinical trial collaboration and supply agreement with Merck (MRK)/b) on September 14, 2026 to evaluate Perspective’s targeted alpha therapy in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in FAP-α–positive solid tumors.
The combination will be tested via an amendment to Perspective’s ongoing Phase 1/2a, multi-center, open-label, dose-finding and dose-expansion study (NCT06710756) in patients with certain non-small cell lung and colorectal cancers expressing FAP-α. The study has completed enrollment in the first three monotherapy dose cohorts. Perspective sponsors the trial, while Merck supplies pembrolizumab at no cost. PSV359 is designed to deliver the alpha-emitting isotope 212Pb to FAP-α–expressing tumors, with related imaging agents (203Pb/68Ga, PSV377) used to select patients and assess FAP-α expression.
Merck (MRK)/b) will participate in the Morgan Stanley 24th Annual Global Healthcare Conference with a fireside chat on Sept. 14, 2026, at 3:20 p.m. ET.Chairman and CEO Robert M. Davis and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled speakers. Investors, analysts, media and the public are invited to listen to a live audio webcast of the presentation via a company-provided weblink.
Merck (MRK) will participate in the Wells Fargo 21st Annual Healthcare Conference with a fireside chat on Wednesday, Sept. 9, 2026, at 2:15 p.m. ET.
Executive vice president and CFO Caroline Litchfield and Dr. Dean Y. Li, president of Merck Research Laboratories, will speak, with a live audio webcast available to the public via the provided weblink.