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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) 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.
Merck Animal Health (NYSE:MRK) released findings from a comprehensive global survey highlighting significant gaps in flea and tick prevention for pets. The study, involving 4,072 pet owners and 582 veterinarians across 15 countries, revealed that while 83% of pet owners consider flea and tick treatment crucial, many struggle with consistent administration.
Key findings show that despite 80% of pet owners feeling confident in administering medication, 74% of veterinarians worry about inconsistent treatment administration. In the U.S., two-thirds of veterinarians report that most pet owners don't follow year-round treatment plans. The survey also found that 65% of veterinarians would likely recommend an annual medication option, while 75% of pet owners are willing to try once-yearly treatments.
Merck (NYSE:MRK) and Daiichi Sankyo announced that their novel B7-H3 directed antibody drug conjugate (ADC) ifinatamab deruxtecan (I-DXd) has received Breakthrough Therapy Designation (BTD) from the FDA for treating extensive-stage small cell lung cancer in adults who experienced disease progression after platinum-based chemotherapy.
The BTD, which marks the first designation for ifinatamab deruxtecan and the first since the Merck-Daiichi Sankyo collaboration began, was granted based on data from the IDeate-Lung01 phase 2 trial and supported by the IDeate-PanTumor01 phase 1/2 trial. The primary analysis results will be presented at the upcoming IASLC 2025 World Conference on Lung Cancer.
Merck (NYSE: MRK) announced positive Phase 3 results for KEYTRUDA plus Padcev in treating muscle-invasive bladder cancer (MIBC) patients ineligible for cisplatin-based chemotherapy. The KEYNOTE-905 trial demonstrated statistically significant improvements in event-free survival, overall survival, and pathologic complete response rate when the combination therapy was administered before and after surgery, compared to surgery alone.
This marks a historic breakthrough as the first systemic therapy to improve survival in this patient population and the first positive Phase 3 study for cisplatin-ineligible MIBC patients. The safety profile aligned with known profiles of both drugs, with no new safety concerns identified. The companies plan to present detailed results at an upcoming medical meeting and share findings with global regulatory authorities.