Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) has entered into an exclusive license agreement with Jiangsu Hengrui Pharmaceuticals for HRS-5346, an investigational oral Lipoprotein(a) inhibitor for cardiovascular disease. The deal grants Merck exclusive rights to develop, manufacture, and commercialize HRS-5346 worldwide, except in the Greater China region.

Key financial terms include:

• $200 million upfront payment to Hengrui
• Up to $1.77 billion in potential milestone payments
• Royalties on net sales if approved

HRS-5346 is currently in Phase 2 clinical trials in China. The transaction is expected to close in Q2 2025, subject to Hart-Scott-Rodino Antitrust approval. Merck anticipates recording a pre-tax charge of $200 million ($0.06 per share) in both GAAP and non-GAAP results upon closing.

Merck (MRK) announced new clinical and outcomes research data presentations at the American College of Cardiology's Annual Scientific Session (ACC.25) in Chicago, March 29-31. The highlight is the Phase 3 ZENITH trial results for WINREVAIR™ (sotatercept-csrk) in treating pulmonary arterial hypertension (PAH) patients, which concluded early due to overwhelming efficacy.

The company will present four outcomes research presentations on cholesterol management, including real-world data on healthcare utilization costs for dyslipidemia treatment and LDL-C measurement patterns. Research focuses on barriers to achieving LDL-C goals, noting that nearly two-thirds of individuals don't reach their targets. The presentations include a systematic review of residual atherosclerotic cardiovascular disease risk in statin users and a model estimating the impact of lipid-lowering therapy treatment patterns.

Merck (NYSE: MRK) announced positive results from two Phase 3 trials of its investigational once-daily oral two-drug regimen doravirine/islatravir (DOR/ISL) for HIV-1 treatment. The trials demonstrated non-inferiority to existing therapies in maintaining viral suppression at Week 48.

Key findings from the trials:

• In MK-8591A-052 trial: 1.5% of DOR/ISL patients had viral load ≥50 copies/mL vs 0.6% on BIC/FTC/TAF, with 91.5% maintaining viral suppression
• In MK-8591A-051 trial: 1.4% of DOR/ISL patients had viral load ≥50 copies/mL vs 4.9% on baseline antiretroviral therapy, with 95.6% maintaining viral suppression

The safety profile was comparable to existing treatments, with no treatment-emergent resistance observed. Merck plans to submit applications for marketing authorization by mid-2025.

Merck (MRK) has unveiled a new $1 billion, 225,000-square-foot vaccine manufacturing facility in Durham, North Carolina. This expansion is part of the company's broader $12 billion U.S. capital investment initiative since 2018, with an additional $8 billion planned by 2028.

The state-of-the-art facility incorporates advanced technologies including data analytics, generative AI, 3D printing, and a digital twin training center for simulating manufacturing processes. This investment demonstrates Merck's commitment to expanding domestic manufacturing and R&D capabilities while creating new jobs in the United States.

The FDA has granted priority review to Merck's (NYSE: MRK) supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) as a perioperative treatment for resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The application is based on the Phase 3 KEYNOTE-689 trial, which demonstrated a statistically significant improvement in event-free survival and major pathological response compared to standard care.

The FDA has set a target action date of June 23, 2025. This review is being conducted under Project Orbis, allowing coordinated review among international health authorities including Israel, Canada, Australia, Singapore, Brazil, and Switzerland.

KEYTRUDA's safety profile remained consistent with previous studies. If approved, this would represent the first advancement in treatment options for resectable LA-HNSCC in over two decades.

Merck (NYSE: MRK) has announced that two of its top executives will participate in an upcoming healthcare conference. Caroline Litchfield, executive vice president and chief financial officer, and Dr. Dean Y. Li, executive vice president and president of Merck Research Laboratories, are scheduled to engage in a fireside chat at the TD Cowen 45th Annual Health Care Conference.

The event is scheduled for Monday, March 3, 2025, at 2:30 p.m. EST. The company has made the session accessible to investors, analysts, media representatives, and the general public through a live audio webcast, which will be available via a provided weblink.

Merck (MRK) has received European Commission conditional approval for WELIREG® (belzutifan), the first oral HIF-2α inhibitor in the EU, for two indications: treatment of adult patients with von Hippel-Lindau (VHL) disease and advanced clear cell renal cell carcinoma (RCC).

The approval is based on the LITESPARK-004 and LITESPARK-005 trials. In VHL disease-associated RCC patients, WELIREG showed a 49% objective response rate. For CNS hemangioblastomas, the response rate was 63%, and for pNET, it reached 83%. In advanced RCC patients, WELIREG reduced disease progression or death risk by 25% versus everolimus, with a 22% objective response rate compared to 4% for everolimus.

The conditional approval will be valid for one year, subject to yearly renewal pending additional clinical data. WELIREG is now approved in over 30 countries for certain advanced RCC patients and in more than 40 countries for VHL disease-associated tumors.

Merck (MRK) has initiated waveLINE-010, a pivotal Phase 3 clinical trial evaluating zilovertamab vedotin in combination with R-CHP compared to R-CHOP alone for previously untreated diffuse large B-cell lymphoma (DLBCL) patients. The trial, which has begun global recruitment, will enroll approximately 1,046 patients.

Zilovertamab vedotin is Merck's investigational antibody-drug conjugate targeting ROR1. The study's primary endpoint is progression-free survival, with secondary endpoints including complete response rate, overall survival, event-free survival, duration of complete response, and safety.

The initiation follows encouraging results from the Phase 2 waveLINE-007 trial. The drug is also being evaluated in the Phase 2/3 waveLINE-003 trial for relapsed or refractory DLBCL. Initial data was presented at the 66th American Society of Hematology Annual Meeting in December 2024.

Merck (MRK) reported strong financial results for Q4 and full-year 2024. Fourth-quarter worldwide sales reached $15.6 billion, up 7% (9% ex-forex) from Q4 2023, while full-year sales hit $64.2 billion, increasing 7% (10% ex-forex) from 2023.

Key performance highlights include KEYTRUDA sales growing 18% to $29.5 billion, WINREVAIR sales of $419 million, and Animal Health sales growing 4% to $5.9 billion. However, GARDASIL/GARDASIL 9 sales declined 3% to $8.6 billion.

Q4 GAAP EPS was $1.48 and non-GAAP EPS was $1.72, both including a $0.23 per share charge related to business development transactions. Full-year 2024 GAAP EPS was $6.74, while non-GAAP EPS reached $7.65.

For 2025, Merck expects worldwide sales between $64.1-65.6 billion and non-GAAP EPS of $8.88-9.03, including a one-time charge of approximately $0.09 per share for an anticipated milestone payment.