Merck & Co Stock Price, News & Analysis

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.

Merck (NYSE: MRK) will present new cardio-pulmonary data at the AHA Scientific Sessions 2025 in New Orleans, Nov 7–10, 2025. Key items include first detailed Phase 3 results from the CORALreef Lipids trial (enlicitide decanoate) and the CORALreef HeFH trial, plus a pooled mortality and major morbidity analysis for WINREVAIR (sotatercept) from PULSAR, STELLAR and ZENITH.

An investor event is scheduled Nov 9, 2025, 6:00 p.m. CT with a live webcast and call access for investors and the public.

Merck (NYSE: MRK) said the FDA granted priority review for two sBLAs seeking approval of KEYTRUDA and KEYTRUDA QLEX, each combined with Padcev, for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin. The FDA set a PDUFA date of April 7, 2026. The applications are based on Phase 3 KEYNOTE-905 (EV-303) results with median follow-up 25.6 months: event-free survival reduced EFS events by 60% (HR=0.40), overall survival risk of death reduced by 50% (HR=0.50), and pathologic complete response rose to 57.1% vs 8.6% (increase 48.3 percentage points).

Merck (NYSE: MRK) presented a systematic literature review at IDWeek 2025 summarizing 15 U.S. studies (2015–2025) and CDC ABC surveillance on pneumococcal serotypes targeted by CAPVAXIVE (21‑valent) versus PCV20. The review found CAPVAXIVE‑unique serotypes were more prevalent in U.S. adults with pneumococcal disease and showed higher antimicrobial resistance in some serotypes.

Key figures: in adults ≥65 years, CAPVAXIVE‑unique serotypes accounted for 34.8% of invasive disease vs 8.5% for PCV20‑unique; ages 50–64: ~30% vs ~15%. Reported resistance included serotype 35B (penicillin 96%, erythromycin 89%) and 23A (penicillin 72%, erythromycin 46%); multidrug resistance was highest for 19F (42%) and 23A (27%). CAPVAXIVE is indicated for adults ≥18 and reportedly covers ~84% of IPD in adults 50+ vs ~52% for PCV20 (CDC ABC 2018–2022).