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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) and Eisai announced that the Phase 3 LITESPARK-012 trial in first-line advanced clear cell renal cell carcinoma did not meet dual primary endpoints of progression-free survival (PFS) and overall survival (OS) versus KEYTRUDA plus LENVIMA at a pre-specified interim analysis. The safety profiles were consistent with prior studies. A full data evaluation is ongoing and results will be shared with the scientific community. The companies noted this does not affect other LITESPARK trials; two sNDAs from LITESPARK-011 have FDA review with an Oct. 4, 2026 PDUFA date.
Merck (NYSE: MRK) said the FDA granted priority review for two supplemental BLAs for KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, to treat cisplatin-eligible muscle-invasive bladder cancer (MIBC).
The applications rely on Phase 3 KEYNOTE-B15, which showed statistically significant and clinically meaningful improvements in event-free survival and overall survival. The FDA set a PDUFA date of August 17, 2026. If approved, these regimens would be the first perioperative treatments for MIBC regardless of cisplatin eligibility.
Merck (NYSE: MRK) announced that the European Commission approved ENFLONSIA (clesrovimab) on April 17, 2026 for prevention of RSV lower respiratory tract disease in neonates and infants during their first RSV season. ENFLONSIA offers a single, non-weight-based dose designed to provide protection through five months and is authorized across the 27 EU member states plus Iceland, Liechtenstein and Norway. Approval is supported by pivotal CLEVER and interim SMART trial data, with clinical results published in the New England Journal of Medicine in September 2025. Availability timing will vary by country pending reimbursement.
Merck (NYSE: MRK) and Daiichi Sankyo announced the FDA has accepted the BLA for ifinatamab deruxtecan and granted Priority Review for adult patients with extensive-stage small cell lung cancer (ES-SCLC) after platinum-based chemotherapy.
The PDUFA date is October 10, 2026; the BLA is also under RTOR and Project Orbis and is supported by IDeate-Lung01 Phase 2 and IDeate-PanTumor01 Phase 1/2 data. If approved, the drug would be a potential first-in-class B7-H3 directed DXd ADC.
Merck (NYSE: MRK) has commenced a cash tender offer to acquire Terns Pharmaceuticals (Nasdaq: TERN) at $53.00 per share. The offer expires one minute after 11:59 p.m. ET on May 4, 2026, and the transaction is expected to close in Q2 2026.
The closing is conditional on the tender of more than 50% of outstanding Terns shares, completion of the Hart-Scott-Rodino waiting period, and customary closing conditions. Upon successful closing, Terns will become a wholly owned subsidiary of Merck.
Merck (NYSE: MRK) announced initiation of MALBEC, a pivotal Phase 2b/3 trial of MK-8748 (Tiespectus) for neovascular age-related macular degeneration (NVAMD) on April 2, 2026. The program follows Phase 1/2a RIOJA results and includes a second NVAMD study scheduled to begin later in 2026 (NCT07496567).
MK-8748 is a bispecific antibody that agonizes Tie2 and inhibits VEGF to target vascular leakage; Merck also advances MK-3000 in registrational Phase 2b/3 studies for diabetic macular edema.
Merck (NYSE: MRK) announced European Commission approval of KEYTRUDA (pembrolizumab) plus paclitaxel ± bevacizumab for adults with PD-L1 (CPS ≥1) platinum-resistant recurrent ovarian carcinoma after one or two prior systemic regimens.
The approval, based on Phase 3 KEYNOTE-B96, showed improved PFS (HR=0.72) and OS (HR=0.76) and covers all 27 EU member states plus Iceland, Liechtenstein and Norway; national reimbursement will determine local availability.
Merck (NYSE: MRK) will hold a first-quarter 2026 sales and earnings conference call at 9:00 a.m. ET on Thursday, April 30 for institutional investors and analysts. A live audio webcast will be available to the public.
A replay, the sales and earnings news release, supplemental financial disclosures and presentation slides will be posted at www.merck.com. Participants may join by dialing (800) 369-3351 (U.S./Canada) or (517) 308-9448 with access code 9818590.
Merck (NYSE: MRK) announced Phase 3 CORALreef AddOn results showing investigational oral PCSK9 inhibitor enlicitide decanoate reduced LDL-C by 64.6% at eight weeks versus baseline when added to statins and delivered significantly greater LDL-C reductions versus bempedoic acid, ezetimibe, and their combination.
Enlicitide improved goal attainment and key secondary lipids (ApoB, non‑HDL‑C, Lp(a)) with a safety profile consistent with prior CORALreef trials; FDA assigned a Commissioner’s National Priority Voucher in December 2025.
Merck (NYSE: MRK) reported positive Phase 2 CADENCE results for WINREVAIR (sotatercept-csrk) in adults with CpcPH-HFpEF, meeting the primary endpoint with a significant PVR reduction at week 24 (0.3 mg/kg: -1.02 WU, p=0.004; 0.7 mg/kg: -0.75 WU, p=0.024). Multiple hemodynamic, biomarker and clinical trends support advancing to a registrational Phase 3 program.