Merck & Co Stock Price, News & Analysis

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).

Merck (NYSE: MRK) reported long-term analyses showing sustained survival benefit for KEYTRUDA (pembrolizumab) in non-small cell lung cancer (NSCLC) across earlier and advanced stages, presented at ESMO Congress 2025.

KEYNOTE-671 five-year exploratory follow-up showed improved overall survival (HR=0.74) and event-free survival (HR=0.58) for perioperative KEYTRUDA plus chemotherapy versus chemotherapy-placebo, with five-year OS rates of 64.6% versus 53.6% and five-year EFS rates of 49.9% versus 26.5%. Long-term (8–10 year) follow-ups of KEYNOTE-001/010/024/042 also showed durable OS benefits versus chemotherapy in selected PD-L1 populations.

Merck (NYSE: MRK) broke ground on a $3 billion, 400,000-square-foot Center of Excellence for Pharmaceutical Manufacturing at its Elkton, Virginia site on October 20, 2025. The facility will house Active Pharmaceutical Ingredient and Drug Product capabilities for small molecule manufacturing and testing and is expected to potentially create more than 500 full-time roles plus 8,000 construction jobs.

This project is part of a broader plan to invest more than $70 billion beginning in 2025 to expand U.S. manufacturing and R&D; Merck also cited nearly $6 billion in U.S. manufacturing investments announced in 2025 and forecasts 48,000+ construction-related jobs by 2029.

Merck (NYSE: MRK) and Daiichi Sankyo reported Phase 2 REJOICE-Ovarian01 results for raludotatug deruxtecan in platinum-resistant ovarian, primary peritoneal and fallopian tube cancer (data cut-off Feb 26, 2025).

Key outcomes: a confirmed objective response rate of 50.5% (n=107) across three doses, disease control rate 77.6%, and median time to response ~7.1 weeks. The 5.6 mg/kg dose was selected for Phase 3. Safety: common TEAEs included nausea, anemia, asthenia and neutropenia; 3.7% had treatment-related ILD/pneumonitis. R-DXd received Breakthrough Therapy Designation from FDA in Sept 2025.