Merck & Co (MRK)

Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2025.

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Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced results from the Phase 3 LEAP-012 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, in combination with transarterial chemoembolization (TACE) for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma (HCC).

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Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for the treatment of resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1. This approval marks the first and only anti-PD-1 treatment option for certain patients with resectable LA-HNSCC in the European Union (EU) and the third approval for KEYTRUDA in HNSCC in the EU.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 LITESPARK-022 trial in patients with clear cell renal cell carcinoma (RCC) following nephrectomy. In this study, KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with WELIREG® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, given in the adjuvant setting, demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS), the study’s primary endpoint, compared to KEYTRUDA in combination with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced that the Phase 3 LITESPARK-011 trial evaluating the dual oral regimen of WELIREG® (belzutifan), Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, plus LENVIMA® (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, met one of its primary endpoints of progression-free survival (PFS) for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with anti-PD-1/L1 therapy.

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk) for injection, 45mg, 60mg. WINREVAIR, an activin signaling inhibitor, is now FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death. WINREVAIR was initially approved based on the pivotal STELLAR study in March 2024. Today’s approval expanded the indication of WINREVAIR to include components of the clinical worsening events: hospitalization for PAH, lung transplantation and death.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced plans to present new research from the company’s cardio-pulmonary portfolio and pipeline at the American Heart Association (AHA) Scientific Sessions 2025 in New Orleans, La., from November 7–10. Data presented at AHA highlight Merck’s continued dedication to advancing research across hypercholesterolemia and pulmonary arterial hypertension (PAH) to help address the global burden of cardio-pulmonary diseases.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev® (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date of April 7, 2026, marking the first concurrent review of both KEYTRUDA and KEYTRUDA QLEX for the same novel indication.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of findings from a systematic literature review of studies on the epidemiology and antimicrobial resistance (AMR) of pneumococcal serotypes covered by CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) in U.S. adults. The evaluation examined 15 studies published between 2015 and 2025 to assess the serotype-specific burden of pneumococcal disease (PD) associated with serotypes covered by CAPVAXIVE but not PCV20 (pneumococcal 20-valent conjugate vaccine) (CAPVAXIVE-unique serotypes: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, 35B) compared to serotypes covered by PCV20 but not CAPVAXIVE (PCV20-unique serotypes: 1, 4, 5, 6B, 9V, 14, 18C, 19F, 23F). Findings were presented at IDWeek 2025 in Atlanta, GA.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced new long-term data highlighting the sustained survival benefits of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in treating non-small cell lung cancer (NSCLC). The results are based on the exploratory five-year analyses of KEYNOTE-671 evaluating KEYTRUDA as part of a neoadjuvant followed by adjuvant (perioperative) treatment regimen for patients with resectable NSCLC; and the eight-year analyses of KEYNOTE-024 and -042 and the 10-year analyses of KEYNOTE-001 and -010 evaluating KEYTRUDA as monotherapy in certain patients with locally advanced or metastatic NSCLC.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today the start of construction for a $3 billion, 400,000-square-foot pharmaceutical manufacturing facility at its Elkton, Virginia, site.

Results from the phase 2 (dose optimization) part of the REJOICE-Ovarian01 phase 2/3 trial showed that raludotatug deruxtecan (R-DXd) demonstrated clinically meaningful response rates in patients with recurrent platinum-resistant ovarian, primary peritoneal or fallopian tube cancer. These data were presented today during a late-breaking proffered paper session (LBA42) at the 2025 European Society for Medical Oncology (#ESMO25) Congress.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of results from the pivotal Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab for the treatment of patients with platinum-resistant recurrent ovarian cancer. These late-breaking data will be presented today during a Presidential Symposium session at the European Society for Medical Oncology (ESMO) Congress 2025 (Presentation #LBA3).

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced landmark results demonstrating KEYTRUDA® (pembrolizumab) plus Padcev® (enfortumab vedotin-ejfv) reduced the risk of event-free survival (EFS) events by 60% and reduced the risk of death by 50% when given before and after surgery (radical cystectomy) versus surgery alone, the current standard of care, in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy. These late-breaking data will be presented for the first time today during a Presidential Symposium session at the European Society for Medical Oncology (ESMO) Congress 2025 (Presentation #LBA2) and were selected for an official Press Briefing.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced long-term follow-up data continued to show durable benefit of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, compared to chemotherapy for patients with advanced endometrial carcinoma following at least one prior platinum-based regimen in any setting. The findings, based on five years of follow-up from the Phase 3 KEYNOTE-775/Study 309 trial evaluating KEYTRUDA plus LENVIMA versus chemotherapy (treatment of physician’s choice of doxorubicin or paclitaxel), for these patients with advanced endometrial carcinoma are being presented during a poster session at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany (Presentation #1119P).

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its secondary endpoint of overall survival (OS) for the treatment of patients with platinum-resistant recurrent ovarian cancer in all comers. The trial studied KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab for these patients. As previously announced, KEYNOTE-B96 met its primary endpoint of progression-free survival (PFS) in patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 and in all comers, as well as its secondary endpoint of OS for patients whose tumors express PD-L1, at previous interim analyses. Findings from these prior analyses will be presented in a Presidential Symposium at the upcoming European Society for Medical Oncology (ESMO) Congress 2025.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that it will present new findings from its HIV treatment and prevention pipeline at the 20th European AIDS Conference (EACS 2025) taking place Oct.15-18, 2025, in Paris, France. The company’s presentations will include:

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today the presentation of additional data from the Phase 3 studies of the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir [DOR/ISL (100mg/0.25mg)] in adults with HIV-1 infection that was virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamidei [BIC/FTC/TAF (50 mg/200 mg/25 mg)] in trial MK-8591A-052 or antiretroviral therapy [baseline antiretroviral therapy (bART)] in trial MK-8591A-051. These additional findings will be shared at the 20th European AIDS Conference being held in Paris and follow positive Phase 3 data presented at CROI 2025, which showed that the investigational two-drug regimen of DOR/ISL maintained viral suppression and demonstrated non-inferiority to the three-drug regimen BIC/FTC/TAF in MK-8591A-052 and baseline ART in MK-8591A-051, with no observed treatment-emergent resistance to DOR or ISL.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced new research from more than 100 abstracts across more than 20 types of cancer and multiple treatment settings from the company’s broad and differentiated portfolio and pipeline will be presented at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany, from Oct. 17-21. These data showcase Merck’s commitment to rapidly advancing research across multiple tumor types to help improve outcomes for patients across stages of cancer.

Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In Merck (MRK) To Contact Him Directly To Discuss Their Options

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the completion of the Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”) acquisition. Verona Pharma is now a wholly-owned subsidiary of Merck and the American Depositary Shares (ADS) of Verona Pharma will no longer be listed or traded on the Nasdaq Global Market.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced it has initiated three Phase 2b trials evaluating the safety and efficacy of tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting tumor necrosis factor (TNF)-like cytokine 1A (TL1A), in patients with three immune-mediated inflammatory diseases:

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its third-quarter 2025 sales and earnings conference call with institutional investors and analysts at 9:00 a.m. ET on Thursday, Oct. 30. During the call, company executives will provide an overview of Merck’s performance for the quarter.