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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) is reorganizing its Human Health operating structure into two business units: Oncology and Specialty, Pharma & Infectious Diseases. Jannie Oosthuizen is appointed EVP and president, Oncology and MSD International; Brian Foard joins as EVP and president, Specialty, Pharma & Infectious Diseases effective March 2, 2026.
The company said it is conducting approximately 80 Phase 3 studies and expects >20 new growth drivers over the next several years, aiming to support multiple forthcoming launches and sustained commercial execution.
Merck (NYSE: MRK) reported positive Phase 3 SMART trial second RSV season data for ENFLONSIA (clesrovimab) in infants and children under 2 years at increased risk for severe RSV disease (presented Feb 19, 2026).
Safety in season 2 was generally consistent with season 1, serum concentrations matched pivotal CLEVER trial levels, and results support extrapolation of efficacy and regulatory submissions for an expanded indication through a second RSV season.
Merck (NYSE: MRK) and Mayo Clinic announced a research and development collaboration on February 18, 2026 to apply AI, advanced analytics and multimodal clinical data to support drug discovery and development.
The agreement gives Merck access to Mayo Clinic Platform data—de-identified clinical, genomic, imaging and molecular datasets—plus AI tools, registries and biorepositories to validate AI models and inform target identification in IBD, atopic dermatitis and multiple sclerosis.
Merck (NYSE: MRK) will present multiple genitourinary cancer data sets at the 2026 ASCO GU Cancers Symposium (Feb 26–28, 2026), including Phase 3 KEYNOTE-B15 showing significant improvements in event-free survival, overall survival and pathologic complete response for KEYTRUDA plus Padcev in muscle-invasive bladder cancer.
Additional featured results include LITESPARK-022 (adjuvant KEYTRUDA plus WELIREG) showing disease-free survival benefit and LITESPARK-011 (WELIREG plus LENVIMA) showing progression-free survival benefit in renal cell carcinoma.
Merck (NYSE: MRK) announced FDA approval of KEYTRUDA and KEYTRUDA QLEX plus paclitaxel, with or without bevacizumab, for adults with PD-L1+ (CPS ≥1) platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma after one or two prior systemic regimens.
Approvals are based on Phase 3 KEYNOTE-B96: PFS HR 0.72 (28% risk reduction; p=0.0014), median PFS 8.3 vs 7.2 months; OS HR 0.76 (24% risk reduction; p=0.0053), median OS 18.2 vs 14.0 months. Safety signals include 54% serious adverse reactions and 3.9% fatal reactions.
Merck (NYSE: MRK) reported fourth-quarter 2025 worldwide sales of $16.4 billion (+5% / +4% ex-FX) and full-year sales of $65.0 billion (+1% / +2% ex-FX). Fourth-quarter GAAP EPS was $1.19 and non-GAAP EPS was $2.04; full-year GAAP EPS was $7.28 and non-GAAP EPS was $8.98. Key drivers included KEYTRUDA sales of $31.7 billion (+7%), strong Animal Health performance ($6.4 billion, +8%), and rising contributions from WINREVAIR and CAPVAXIVE. The company completed acquisitions of Verona Pharma and Cidara, reported positive Phase 3 readouts, and set 2026 sales outlook of $65.5–$67.0 billion with non-GAAP EPS guidance of $5.00–$5.15 (includes a one-time ~$3.65 per-share charge).
Merck (NYSE: MRK) announced the Board declared a quarterly cash dividend of $0.85 per share for the second quarter of 2026. Payment is scheduled for April 7, 2026 to shareholders of record at the close of business on March 16, 2026.
Moderna (NASDAQ:MRNA) and Merck (NYSE:MRK) reported median five-year follow-up data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study showing that intismeran autogene plus KEYTRUDA reduced the risk of recurrence or death by 49% (HR=0.510; 95% CI 0.294-0.887; one-sided nominal p=0.0075) versus KEYTRUDA alone in patients with resected high-risk stage III/IV melanoma.
The safety profile remained consistent with prior reports. Moderna and Merck plan further follow-up presentations and continue enrollment across eight Phase 2/3 studies, with the Phase 3 adjuvant melanoma trial fully enrolled.
Merck (NYSE: MRK) initiated the Phase 3 KANDLELIT-007 trial on January 7, 2026 to evaluate oral calderasib (MK-1084) plus subcutaneous KEYTRUDA QLEX versus subcutaneous KEYTRUDA QLEX with pemetrexed and carboplatin or cisplatin in first-line KRAS G12C-mutant, advanced or metastatic nonsquamous NSCLC.
The randomized, open-label global study will enroll approximately 675 patients. The primary endpoint is progression-free survival (PFS) in PD-L1 expressors (TPS ≥1%); secondary endpoints include PFS in all patients, overall survival, response rate, duration of response and safety.
Merck (NYSE: MRK) completed a cash tender offer to acquire Cidara Therapeutics (Nasdaq: CDTX) on January 6, 2026, at a purchase price of $221.50 per share.
Approximately 27,149,333 shares were validly tendered (about 85.96% of outstanding shares); all such shares were accepted and Merck expects prompt payment. Merck will merge a subsidiary into Cidara so remaining shares are converted into cash at the offer price and Cidara common stock will be delisted.
The transaction is expected to be accounted for as an asset acquisition, increasing 2026 research and development expense by approximately $9.0 billion (about $3.65 per share) and reducing GAAP and non-GAAP EPS by about $0.30 per share in the first 12 months. Merck cited CD388, a long-acting, strain-agnostic antiviral for influenza prevention in high-risk individuals, as a strategic rationale.