Merck & Co., Inc. reports news across a global pharmaceutical business known as MSD outside the United States and Canada. Company updates center on human health products for areas such as oncology, cardiometabolic disease and infections; vaccines including Gardasil; and Merck Animal Health medicines, devices and customer-support systems.
Recurring developments include FDA approvals, clinical and regulatory disclosures, research publications, pipeline additions, business development transactions, material agreements, capital-structure updates, governance matters, and operating and financial results. Recent themes include the approved HIV-1 regimen IDVYNSO, investigational programs such as enlicitide decanoate and TERN-701, technology partnerships for research, manufacturing and commercial functions, and animal health digital engagement initiatives.
Merck (MRK) received approval from Japan’s Ministry of Health, Labor and Welfare for KEYTRUDA QLEX / KEYJECT, a subcutaneous formulation of pembrolizumab with berahyaluronidase alfa, for all KEYTRUDA indications currently approved in Japan.
KEYJECT is the first and only subcutaneous immune checkpoint inhibitor in Japan and can be administered by a healthcare provider in about one minute every three weeks or two minutes every six weeks. Approval is supported by Phase 3 trial MK‑3475A‑D77 in treatment‑naïve metastatic NSCLC, which showed comparable pembrolizumab exposure, similar overall response rates (45% vs 42%) and no notable differences in PFS or OS versus intravenous KEYTRUDA, both given with chemotherapy every six weeks. Subcutaneous pembrolizumab formulations are already approved in the U.S. and EU for all KEYTRUDA indications in those regions.
Merck (MRK) received a positive opinion from the EMA’s CHMP recommending approval of KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) as perioperative (neoadjuvant and adjuvant) treatment for adults with resectable muscle-invasive bladder cancer (MIBC), including both cisplatin-eligible and cisplatin-ineligible patients.
The recommendation, which also covers subcutaneous KEYTRUDA SC / KEYTRUDA QLEX, will be reviewed by the European Commission, with a final decision expected by Q4 2026 for the EU, Iceland, Liechtenstein and Norway. The opinion is based on Phase 3 KEYNOTE-B15, where KEYTRUDA plus Padcev reduced risk of event-free survival events by 47% (HR 0.53) and risk of death by 35% (HR 0.65) versus neoadjuvant gemcitabine/cisplatin plus surgery, and improved pathologic complete response rate to 55.8% versus 32.5%. Prior EC approval already covers cisplatin-ineligible MIBC based on KEYNOTE-905.
Merck (MRK) launched Your Hive of Whole Health, a multi-year educational program to help people living with HIV build personalized support networks for whole person care. Unveiled at the 2026 U.S. Conference on HIV/AIDS in Anaheim, the initiative provides tools and resources to support physical, mental, emotional, and social well-being. The program, created with community advisors and featuring advocate Debbie Allen, encourages individuals to identify and nurture their own “Hive” of caregivers, peers, and supporters, with more information available at HiveofWholeHealth.com.
Perspective Therapeutics (CATX) announced a clinical trial collaboration and supply agreement with Merck (MRK)/b) on September 14, 2026 to evaluate Perspective’s targeted alpha therapy in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in FAP-α–positive solid tumors.
The combination will be tested via an amendment to Perspective’s ongoing Phase 1/2a, multi-center, open-label, dose-finding and dose-expansion study (NCT06710756) in patients with certain non-small cell lung and colorectal cancers expressing FAP-α. The study has completed enrollment in the first three monotherapy dose cohorts. Perspective sponsors the trial, while Merck supplies pembrolizumab at no cost. PSV359 is designed to deliver the alpha-emitting isotope 212Pb to FAP-α–expressing tumors, with related imaging agents (203Pb/68Ga, PSV377) used to select patients and assess FAP-α expression.
Merck (MRK)/b) will participate in the Morgan Stanley 24th Annual Global Healthcare Conference with a fireside chat on Sept. 14, 2026, at 3:20 p.m. ET.Chairman and CEO Robert M. Davis and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled speakers. Investors, analysts, media and the public are invited to listen to a live audio webcast of the presentation via a company-provided weblink.
Merck (MRK) will participate in the Wells Fargo 21st Annual Healthcare Conference with a fireside chat on Wednesday, Sept. 9, 2026, at 2:15 p.m. ET.
Executive vice president and CFO Caroline Litchfield and Dr. Dean Y. Li, president of Merck Research Laboratories, will speak, with a live audio webcast available to the public via the provided weblink.
Merck (NYSE: MRK) and Moderna (NASDAQ: MRNA) reported positive topline Phase 3 results from the global INTerpath‑001 trial in completely resected stage IIB‑IV cutaneous melanoma. The combination of intismeran autogene (V940/mRNA‑4157), an individualized mRNA neoantigen therapy, plus KEYTRUDA met the primary endpoint of recurrence‑free survival and a key secondary endpoint of distant metastasis‑free survival versus KEYTRUDA alone.
According to the companies, this is the first positive Phase 3 readout for an individualized neoantigen therapy and for an mRNA‑based cancer therapy, and the first Phase 3 trial to show a clinically meaningful improvement over KEYTRUDA monotherapy in the adjuvant melanoma setting. The study enrolled 1,137 patients randomized 2:1 to intismeran+KEYTRUDA versus KEYTRUDA alone, with dosing for up to about one year. Safety for both agents was consistent with prior studies, with no new safety signals observed. The trial will continue to assess additional secondary endpoints, including overall survival, and Merck and Moderna plan to present the data at an international medical meeting and to discuss potential regulatory submissions.
Merck (NYSE: MRK) reports that the U.S. FDA has accepted a supplemental Biologics License Application for ENFLONSIA™ (clesrovimab-cfor) to expand its indication to prevent RSV lower respiratory tract disease in children under two years of age at increased risk for severe RSV through their second RSV season. The FDA set a PDUFA target action date of March 22, 2027. The EMA also accepted an application in July 2026 to expand EU marketing authorization for the same high‑risk population.
Both submissions are supported by the Phase 3 SMART trial (MK-1654-007), a randomized, partially blind, palivizumab‑controlled study over two RSV seasons. Season 1 enrolled 1,003 infants (105 mg ENFLONSIA vs monthly palivizumab), and 276 eligible children received a 210 mg ENFLONSIA dose in season 2. ENFLONSIA is already approved in the U.S., EU and other markets for prevention of RSV LRTD in infants during their first season, using a fixed 105 mg intramuscular dose with a 30‑month shelf life.
Merck (NYSE: MRK) reported second-quarter 2026 worldwide sales of $16.6 billion, up 5% year over year (4% ex-FX), led by oncology, cardiometabolic, respiratory and Animal Health. KEYTRUDA/KEYTRUDA QLEX delivered $8.4 billion in sales (+5%), including $463 million from KEYTRUDA QLEX, while WINREVAIR reached $588 million (+75%). Animal Health sales were $1.8 billion (+8%).
Merck posted a GAAP net loss of $1.3 billion (EPS -$0.54) and non-GAAP EPS of -$0.13, both including a $2.31 per-share charge for the Terns acquisition, which drove R&D to $9.7 billion. The company received U.S. FDA approval for LIPFENDRA, the first once-daily oral PCSK9 inhibitor, and secured several oncology label expansions, including new KEYTRUDA/KEYTRUDA QLEX combinations and Breakthrough Therapy designation for calderasib plus KEYTRUDA.
Merck narrowed and raised its 2026 sales outlook to $66.3–$67.3 billion and now expects full-year non-GAAP EPS of $2.66–$2.76, which includes $2.43 per share of charges related to the Terns transaction.
Merck (NYSE: MRK) announced that its Board of Directors has declared a fourth-quarter 2026 quarterly dividend of $0.85 per share on its common stock. The dividend is payable on October 7, 2026, to shareholders of record as of the close of business on September 15, 2026.