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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) will present more than 100 abstracts across 20+ cancer types at ESMO Congress 2025 (Oct 17–21) in Berlin. Key highlights include first-time Phase 3 data from KEYNOTE-905 (enfortumab vedotin + pembrolizumab) and KEYNOTE-B96 (pembrolizumab ± bevacizumab) featured in Presidential Symposium sessions.
Long-term follow-up includes 5‑year and 10‑/8‑year exploratory results for pembrolizumab in multiple lung and endometrial studies. Multiple investigational ADCs (R-DXd, I-DXd, sac-TMT) and other pipeline candidates will have clinical updates.
Merck (NYSE: MRK) completed the acquisition of Verona Pharma on October 7, 2025, acquiring all ADS for $107 per ADS (each ADS = eight ordinary shares) for a total transaction value of approximately $10 billion. Verona Pharma becomes a wholly owned Merck subsidiary and its ADS will no longer trade on Nasdaq.
The deal adds Ohtuvayre (ensifentrine)—an FDA‑approved (June 2024) first‑in‑class inhaled maintenance treatment for COPD—to Merck’s cardio‑pulmonary portfolio, and Ohtuvayre is being evaluated in bronchiectasis trials. Merck expects most of the purchase price to be capitalized as an intangible asset and amortized for GAAP purposes, and estimates a ~$0.16 negative impact on non‑GAAP EPS in the first 12 months related to financing costs partially offset by Ohtuvayre performance.
Merck (NYSE: MRK) announced on October 6, 2025 the initiation of three Phase 2b trials of tulisokibart (MK-7240) in hidradenitis suppurativa, radiographic axial spondyloarthritis, and rheumatoid arthritis.
According to the press release, global recruitment has begun with a target enrollment of more than 640 patients across the three studies (MK-7240-12, MK-7240-013, MK-7240-014). The company notes tulisokibart is already in Phase 3 trials for ulcerative colitis and Crohn’s disease and in a Phase 2 study for systemic sclerosis-associated interstitial lung disease, bringing the program to investigation in six diseases.
Merck (NYSE: MRK) has scheduled its third-quarter 2025 sales and earnings conference call for Thursday, October 30, 2025, at 9:00 a.m. ET. The call will feature company executives presenting an overview of Merck's quarterly performance.
Institutional investors, analysts, media, and the public can access the live audio webcast through a provided weblink. A replay of the webcast, earnings release, supplemental financial disclosures, and results presentation slides will be available on www.merck.com. Participants can also join via phone using the toll-free numbers (800) 369-3351 for U.S. and Canada or (517) 308-9448 with access code 9818590.
Merck (NYSE:MRK) announced positive Phase 3 HYPERION trial results for WINREVAIR™ (sotatercept-csrk) in recently diagnosed pulmonary arterial hypertension (PAH) patients. The study demonstrated that WINREVAIR reduced clinical worsening events risk by 76% compared to placebo in combination with background therapy.
Key findings include: 10.6% of WINREVAIR-treated patients versus 36.9% in the placebo group experienced clinical worsening events. The trial showed 29.4% of treated patients achieved multicomponent improvement, and 60.1% maintained or achieved a low REVEAL LITE 2 score. The safety profile remained consistent with previous trials, with adverse events occurring in 89.4% of WINREVAIR patients versus 90.0% in the placebo group.
Merck (NYSE: MRK) has received FDA approval for KEYTRUDA QLEX™, the first subcutaneously administered immune checkpoint inhibitor. This groundbreaking treatment can be administered in as little as one minute, compared to the traditional 30-minute IV infusion of KEYTRUDA.
The approval covers 38 solid tumor indications and is supported by a pivotal trial in non-small cell lung cancer (NSCLC) patients. The trial demonstrated comparable results between KEYTRUDA QLEX and IV KEYTRUDA, with similar overall response rates of 45% vs 42% respectively, and no notable differences in progression-free survival and overall survival.
KEYTRUDA QLEX will be available in the U.S. by late September 2025, offering flexible dosing options of either one-minute administration every three weeks or two-minute administration every six weeks, with injection sites in the thigh or abdomen.
Merck (NYSE: MRK) has received a positive recommendation from the European Medicines Agency's CHMP for ENFLONSIA™ (clesrovimab), a preventive treatment for respiratory syncytial virus (RSV) in infants. If approved by the European Commission, ENFLONSIA will become the first and only RSV preventive option in Europe offering consistent dosing regardless of infant weight.
The recommendation is based on data from two pivotal trials: the Phase 2b/3 CLEVER trial and Phase 3 SMART trial, both recently published in the New England Journal of Medicine. ENFLONSIA is a long-acting monoclonal antibody designed to provide protection through 5 months, covering a typical RSV season. The treatment has already received approval in the United States and United Arab Emirates in June 2025.
Merck (NYSE: MRK) received two positive CHMP opinions for KEYTRUDA®. The first recommends approval for a new subcutaneous (SC) administration route for all adult indications in the EU, which could reduce administration time to just 1-2 minutes compared to traditional IV infusion. KEYTRUDA SC demonstrated comparable results to standard KEYTRUDA in clinical trials.
The second opinion recommends approval for KEYTRUDA as a perioperative treatment for locally advanced head and neck squamous cell carcinoma (LA-HNSCC) in adults with PD-L1 expressing tumors. This recommendation is based on the Phase 3 KEYNOTE-689 trial, which showed significant improvement in event-free survival. Final EC decisions for both recommendations are expected in Q4 2025.
Merck (NYSE:MRK) and Daiichi Sankyo announced that their drug candidate raludotatug deruxtecan (R-DXd) has received Breakthrough Therapy Designation (BTD) from the FDA. The designation is for treating adult patients with CDH6-expressing platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers who have previously received bevacizumab treatment.
The BTD, which marks the first for R-DXd and second since the Merck-Daiichi Sankyo collaboration, was granted based on data from a phase 1 trial and the ongoing REJOICE-Ovarian01 phase 2/3 trial. R-DXd is a potential first-in-class CDH6 directed antibody drug conjugate (ADC) designed to address the significant unmet medical need in platinum-resistant cancers.
The designation will help accelerate the development and regulatory review of R-DXd, with detailed trial results expected to be presented at an upcoming medical meeting.Merck (NYSE: MRK) announced positive Phase 3 STRIDE-13 trial results for CAPVAXIVE®, their 21-valent pneumococcal conjugate vaccine, at the 6th ESCMID Conference on Vaccines. The trial evaluated the vaccine in children and adolescents aged 2-18 years with chronic medical conditions that increase pneumococcal disease risk.
The study demonstrated that CAPVAXIVE elicited immune responses to all 21 serotypes, was noninferior to PPSV23 for 12 shared serotypes, and superior for 9 unique serotypes. The vaccine showed comparable safety profiles between groups, with similar adverse events rates. CAPVAXIVE potentially covers 78% of IPD cases in at-risk children and adolescents, including 11 unique serotypes accounting for 34% of cases.