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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) 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.
Merck (NYSE: MRK) announced promising results from the IDeate-Lung01 Phase 2 trial of ifinatamab deruxtecan (I-DXd) in treating extensive-stage small cell lung cancer (ES-SCLC). The trial demonstrated a 48.2% objective response rate in 137 previously treated patients.
Key findings include median overall survival of 10.3 months, progression-free survival of 4.9 months, and a disease control rate of 87.6%. In second-line treatment patients, the response rate increased to 56.3%. The drug received FDA Breakthrough Therapy Designation in August 2025 for ES-SCLC patients who progressed after platinum-based chemotherapy.
The safety profile showed grade 3 or higher treatment-related adverse events in 36.5% of patients, with neutropenia, lymphopenia, and anemia being most common. Treatment-related interstitial lung disease occurred in 12.4% of patients.
Merck (NYSE:MRK) announced positive Phase 3 trial results for enlicitide decanoate, the first oral PCSK9 inhibitor for treating adults with hypercholesterolemia. The CORALreef Lipids trial met all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful reductions in LDL-C compared to placebo at Week 24.
The study showed significant reductions in non-HDL-C, apolipoprotein B, and lipoprotein(a). The drug demonstrated a favorable safety profile with comparable adverse event rates and discontinuations between treatment groups. This marks the third Phase 3 trial to show positive results for enlicitide, positioning it as a potential game-changer in LDL-C management.
Merck (NYSE:MRK) has announced that its top executives will participate in an upcoming healthcare conference. Chairman and CEO Robert M. Davis, along with Dr. Dean Y. Li, executive vice president and president of Merck Research Laboratories, will engage in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 8, 2025, at 2:35 p.m. EDT.
The presentation will be accessible to investors, analysts, media, and the general public through a live audio webcast.
Merck (NYSE: MRK) announced results from two significant studies of VERQUVO® (vericiguat) in patients with chronic heart failure and reduced ejection fraction (HFrEF). The Phase 3 VICTOR trial did not meet its primary endpoint, failing to show statistical significance in reducing cardiovascular death or heart failure hospitalization compared to placebo in stable HFrEF patients.
However, a pre-specified pooled analysis of the VICTOR and VICTORIA trials demonstrated positive results, showing a statistically significant risk reduction in cardiovascular death and heart failure hospitalization across a broader patient spectrum. The safety profile remained consistent with previous trials, and Merck maintains confidence in VERQUVO's approved indication based on the earlier VICTORIA trial results.
Merck (NYSE: MRK) announced its participation in the upcoming 2025 Wells Fargo Healthcare Conference. Caroline Litchfield, executive vice president and CFO, along with Dr. Eliav Barr, SVP and chief medical officer of Merck Research Laboratories, will engage in a fireside chat on September 4, 2025, at 11:50 a.m. EDT.
The presentation will be accessible through a live audio webcast, open to investors, analysts, media, and the general public.
Merck (NYSE:MRK) and Daiichi Sankyo have initiated the HERTHENA-Breast04 phase 3 trial evaluating patritumab deruxtecan (HER3-DXd) for patients with metastatic hormone receptor positive, HER2 negative breast cancer. The trial will assess the drug against investigator's choice of treatment in patients who experienced disease progression following endocrine and CDK4/6 inhibitor therapy.
The study's initiation follows promising results from the ICARUS-Breast01 and a previous phase 1/2 trial. This development is particularly significant as only 30% of patients with advanced or metastatic disease survive five years post-diagnosis, highlighting a critical need for new treatment options in this challenging disease setting.
Merck (NYSE: MRK) will present extensive new research data at the European Society of Cardiology Congress (ESC) 2025 in Madrid, focusing on three major cardiovascular areas: atherosclerotic cardiovascular disease (ASCVD), pulmonary hypertension (PH), and heart failure with reduced ejection fraction (HFrEF).
Key presentations include clinical trial results for WINREVAIR™ (sotatercept-csrk) in PH patients and VERQUVO® (vericiguat) in HFrEF patients through the VICTOR trial. The company will host three symposia discussing LDL-C management in ASCVD, PAH treatment approaches, and CVD challenges.
The comprehensive research program demonstrates Merck's ongoing commitment to addressing cardiovascular disease, which remains the leading cause of death worldwide with approximately 19 million deaths annually.