Welcome to our dedicated page for Merck & Co news (Ticker: MRK), a resource for investors and traders seeking the latest updates and insights on Merck & Co stock.
Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada, generates frequent news across human health, animal health and corporate finance. As a research-intensive biopharmaceutical company with more than a century of history developing medicines and vaccines, Merck regularly announces clinical trial milestones, regulatory decisions, business development transactions and capital markets activity.
Recent news highlights include oncology updates from Merck’s extensive KEYTRUDA program, such as positive Phase 3 data in muscle-invasive bladder cancer and new trials in non-small cell lung cancer using combinations like calderasib (MK-1084) with KEYTRUDA QLEX. The company also reports on progress in other therapeutic areas, including pulmonary arterial hypertension with WINREVAIR, Alzheimer’s disease candidates MK-2214 and MK-1167, and cardiovascular research with the oral PCSK9 inhibitor candidate enlicitide.
Investors following MRK news will also see announcements related to Merck Animal Health, such as the conditional U.S. FDA approval of EXZOLT CATTLE-CA1 for the prevention and treatment of New World screwworm larvae and the treatment and control of cattle fever tick, as well as updates on acquisitions like the planned merger with Cidara Therapeutics to add the influenza candidate CD388 to Merck’s respiratory portfolio.
Corporate and financial communications include quarterly earnings calls, participation in major healthcare conferences and disclosures about note offerings under the company’s shelf registration statement. This news page aggregates these developments so readers can review clinical, regulatory, strategic and financial updates related to Merck & Co., Inc. and its MRK stock in one place.
Merck Animal Health (NYSE: MRK) has announced an $895 million expansion of its facilities in De Soto, Kansas, marking its largest economic development project in recent history. The investment includes $860 million for expanding the existing manufacturing facility and $35 million for research and development laboratories.
The 200,000-square-foot manufacturing expansion will enhance filling and freeze dryer capacity for large molecule vaccines and biologic products. Site preparation begins immediately, creating 2,500 construction jobs, with commercial manufacturing expected to start in 2030, generating over 200 full-time positions. Located in the Animal Health Corridor, this investment is part of Merck's broader commitment to invest more than $21 billion in domestic manufacturing and research capabilities between 2017 and 2028.
Merck (NYSE: MRK) announced that two key executives will participate in a fireside chat at the Bank of America 2025 Global Healthcare Conference. The presenters will be Jannie Oosthuizen, president of Human Health U.S., and Dr. Marjorie Green, senior vice president and head of oncology, global clinical development at Merck Research Laboratories. The presentation is scheduled for Wednesday, May 14, 2025, at 10:40 a.m. PDT / 1:40 p.m. EDT. The company will provide a live audio webcast of the presentation, which will be accessible to investors, analysts, media, and the general public.
Merck has initiated construction of a $1 billion biologics center in Wilmington, Delaware. The 470,000-square-foot facility will serve as a launch and commercial production site for next-generation biologics, including KEYTRUDA for U.S. patients.
The new center at Chestnut Run Innovation & Science Park will create over 500 full-time positions and 4,000 construction jobs. Laboratory operations are expected to begin by 2028, with production starting in 2030. Future expansion could add 1,500 more full-time roles and 26,000 construction jobs.
This investment is part of Merck's larger U.S. manufacturing commitment, which includes:
- $12 billion already allocated for domestic manufacturing enhancement
- $9 billion planned for the next four years
- A recently completed $1 billion vaccine facility in Durham, North Carolina
- $3.5 billion planned for biologics and small molecule manufacturing
Merck (NYSE: MRK) announced groundbreaking results from the Phase 3 KEYNOTE-689 trial evaluating KEYTRUDA® for treating locally advanced head and neck squamous cell carcinoma (LA-HNSCC). After a median follow-up of 38.3 months, KEYTRUDA significantly improved event-free survival, reducing risk by 27% in the intent-to-treat population compared to standard care alone.
Key findings include:
- Median event-free survival was 51.8 months for KEYTRUDA plus standard of care versus 30.4 months for standard care alone
- Risk reduction was even higher (34%) in patients with Combined Positive Score ≥10
- The trial showed significant improvement in major pathological response rates
This marks the first positive trial in over two decades for resectable LA-HNSCC patients. The FDA is reviewing KEYTRUDA for this indication under priority review, with a target action date of June 23, 2025. The safety profile remained consistent with previous studies, with no new safety signals identified.
Merck (MRK) reported Q1 2025 financial results with total worldwide sales of $15.5 billion, showing a 2% decrease from Q1 2024, though growing 1% excluding foreign exchange impact.
Key performance highlights include:
- KEYTRUDA sales grew 4% to $7.2 billion
- WINREVAIR achieved sales of $280 million
- Animal Health sales increased 5% to $1.6 billion
- GARDASIL/GARDASIL 9 sales declined 41% to $1.3 billion
The company reported GAAP EPS of $2.01 and Non-GAAP EPS of $2.22. For full-year 2025, Merck expects worldwide sales between $64.1-65.6 billion and revised Non-GAAP EPS to $8.82-8.97, reflecting a one-time charge related to the Hengrui Pharma agreement and additional tariff costs of $200 million.
Merck (NYSE: MRK) has scheduled its first-quarter 2025 sales and earnings conference call for Thursday, April 24, at 9:00 a.m. ET. The call will feature company executives presenting an overview of Merck's quarterly performance to institutional investors and analysts.
Participants can access the live audio webcast through a provided weblink, with a replay available later at www.merck.com along with the earnings release, supplemental financial disclosures, and results slides. Interested parties can also join via phone using the toll-free number (800) 369-3351 for U.S. and Canada, or (517) 308-9448, with access code 9818590.
Merck (NYSE: MRK) announced groundbreaking results from the Phase 3 ZENITH trial of WINREVAIR™ for pulmonary arterial hypertension (PAH). The study demonstrated a 76% reduction in the risk of major morbidity and mortality events compared to placebo in adults with PAH WHO functional class III or IV at high risk.
At median follow-up of 10.6 months, only 17.4% of WINREVAIR-treated patients experienced major events versus 54.7% in the placebo group. The trial was stopped early due to overwhelming efficacy. Key outcomes included:
- Deaths: 8.1% WINREVAIR vs 15.1% placebo
- Lung transplantation: 1.2% WINREVAIR vs 7.0% placebo
- PAH hospitalizations: 9.0% WINREVAIR vs 50.0% placebo
The safety profile remained consistent with previous studies, with no treatment discontinuations due to adverse events. WINREVAIR is currently approved in over 40 countries based on previous STELLAR trial results.
Merck (MRK) announced positive results from the pivotal Phase 3 trial evaluating subcutaneous pembrolizumab with berahyaluronidase alfa versus intravenous (IV) KEYTRUDA in metastatic non-small cell lung cancer treatment.
Key findings include:
- Noninferior pharmacokinetics demonstrated for subcutaneous administration
- Consistent efficacy and safety profile compared to IV KEYTRUDA
- Median injection time of just two minutes for subcutaneous delivery
- 49.7% reduction in patient chair time and 47.4% reduction in treatment room time
- 45.7% reduction in healthcare professional active time
The FDA has set a PDUFA date of Sept. 23, 2025, for the Biologics License Application review. The European Medicines Agency has also validated an extension application for this new administration route.
Merck (NYSE: MRK) has received European Commission (EC) approval for CAPVAXIVE®, a 21-valent pneumococcal conjugate vaccine for adults aged 18 and older. The vaccine is designed to prevent invasive pneumococcal disease and pneumonia caused by 21 specific Streptococcus pneumoniae serotypes.
The approval, based on the Phase 3 STRIDE clinical program, covers all 27 EU member states, Iceland, Liechtenstein, and Norway. This marks CAPVAXIVE's fourth regulatory approval, following authorizations in the U.S. (June 2024), Canada (July 2024), and Australia (January 2025).
Clinical data demonstrated that CAPVAXIVE was non-inferior to existing vaccines (PCV20 and PPSV23) for shared serotypes and showed superiority for unique serotypes. The vaccine exhibited comparable safety profiles to other pneumococcal vaccines across multiple clinical trials, including studies with immunocompromised patients and those receiving concurrent influenza vaccination.
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.