Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) announced that Prometheus BioSciences, a Merck subsidiary, reached an agreement with Dr. Falk Pharma to discontinue their prior co-development/co-commercialization contract for MK-8690 (formerly PRA-052), an investigational anti-CD30 ligand monoclonal antibody in an early-stage clinical trial.

Under the deal Prometheus secures global rights to MK-8690; Falk will receive a $150 million upfront payment, may receive a development milestone payment, and is eligible for royalties in certain territories. Merck will record a $150 million pre-tax R&D charge (~$0.05 per share) in Q4 under both GAAP and non-GAAP.

Merck Foundation (MRK) launched the Collaborative for Equity in Cardiac Care, a $22 million initiative spanning five years to improve access to person-centered cardiovascular care in underserved U.S. communities, announced November 3, 2025.

Eleven organizations received grants to develop evidence-informed programs, and Johns Hopkins Center for Health Equity will serve as the National Program Office to provide technical assistance, peer learning, cross-site evaluation and results dissemination.

Merck (NYSE: MRK) and Eisai reported Phase 3 LEAP-012 results in unresectable, non-metastatic hepatocellular carcinoma (HCC). At a pre-specified interim analysis, KEYTRUDA plus LENVIMA with TACE did not achieve statistical significance for overall survival (OS) versus TACE alone and the companies judged the likelihood of a future OS success to be low, prompting study closure.

The regimen met the other primary endpoint, progression-free survival (PFS), showing a statistically significant and clinically meaningful improvement; safety was consistent with prior studies. Results will be shared with investigators and the scientific community. Existing regulatory approvals are unaffected.

Merck (NYSE: MRK) announced that the European Commission approved KEYTRUDA (pembrolizumab) for adults with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) whose tumors express PD-L1 (CPS ≥1).

Approval covers KEYTRUDA as neoadjuvant monotherapy, continued as adjuvant with radiotherapy with or without cisplatin, then as monotherapy. The decision is based on Phase 3 KEYNOTE-689, where the KEYTRUDA perioperative regimen reduced risk of event-free survival (EFS) events by 30% (HR=0.70; 95% CI 0.55–0.89; p=0.00140) and doubled median EFS to 59.7 months versus 29.6 months vs comparator in PD-L1 CPS ≥1 patients. The approval follows CHMP positive recommendation and enables marketing across the 27 EU member states plus Iceland, Liechtenstein and Norway, with national reimbursement determining local availability.

Merck (NYSE: MRK) reported positive topline results from the Phase 3 LITESPARK-022 trial in clear cell renal cell carcinoma (RCC) following nephrectomy.

KEYTRUDA (pembrolizumab) plus WELIREG (belzutifan) demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) versus KEYTRUDA plus placebo in the adjuvant setting. The trial will continue to evaluate overall survival (OS), a key secondary endpoint. Merck said safety profiles for the combination were overall consistent with prior studies. Results will be presented at a future medical meeting and shared with regulatory authorities worldwide.

Merck (NYSE: MRK) and Eisai announced that the Phase 3 LITESPARK-011 trial of oral WELIREG (belzutifan) plus LENVIMA (lenvatinib) met the trial's primary endpoint of progression-free survival (PFS) at a pre-specified interim analysis versus cabozantinib in patients with advanced renal cell carcinoma whose disease progressed after anti-PD-1/L1 therapy.

The combination also showed a statistically significant improvement in the trial's key secondary endpoint objective response rate (ORR). A trend toward improved overall survival (OS) was observed but did not reach statistical significance at this interim analysis. Safety profiles were consistent with prior studies and no new safety signals were reported. Companies will discuss data with regulators and present results at a medical meeting.

Merck (NYSE: MRK) announced the U.S. FDA approved an updated indication for WINREVAIR (sotatercept-csrk) on October 27, 2025, for adults with pulmonary arterial hypertension (PAH, WHO Group 1).

The expanded label, based on Phase 3 ZENITH (N=172), notes a 76% reduction in risk of major morbidity and mortality (HR 0.24; 95% CI 0.13–0.43; p<0.0001) and primary endpoint events in 17% of WINREVAIR vs 55% of placebo. ZENITH was stopped early for overwhelming efficacy. The label adds reduction in hospitalization for PAH, lung transplantation and death; safety monitoring for hemoglobin and platelets is required.

Merck (NYSE: MRK) selected eschbach's Shiftconnector to strengthen its Visual Factory and digital manufacturing across global sites, announced Oct 23, 2025. Deployment reached more than 9,000 users in under five months, across multiple sites and all above-site functions. Shiftconnector now serves as a foundational layer to standardize KPIs, improve cross-department communication, embed analytics into 24/7 operations across seven tier management levels, and streamline shift handovers, equipment tracking, and deviation reporting.