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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 (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.
Merck (NYSE: MRK) outlined initial access plans for alimatravir (MK-8527), an investigational once-monthly oral HIV-1 pre-exposure prophylaxis (PrEP) in Phase 3 development. The strategy, focused on low- and middle-income countries (LMICs), is contingent on future regulatory approvals.
Merck has signed seven non-exclusive, royalty-free voluntary licensing agreements with generic manufacturers in sub-Saharan Africa and India, covering 129 LMICs across public and private sectors. The company is also investing early in product manufacturing capacity and supporting regional manufacturing, including prospective partnerships in Latin America, to enable rapid supply if approved.
Alimatravir is being studied in two ongoing Phase 3 EXPrESSIVE trials, supported in part by the Gates Foundation, after a 350-participant Phase 2 study showed similar adverse event rates to placebo and pharmacokinetics supportive of once-monthly oral dosing for PrEP.
Tessera Therapeutics appointed veteran pharmaceutical executive Joseph Romanelli as President and Chief Executive Officer, succeeding Michael Severino, and named him to its board and as a CEO-Partner at Flagship Pioneering. The transition occurs as Tessera advances its first in vivo gene editing program TSRA-196 into the clinic and builds a broader Gene Writing™ pipeline, including a sickle cell disease candidate and in vivo CAR-T efforts for oncology and autoimmune diseases.
TSRA-196 is being jointly developed and commercialized with Regeneron for alpha-1 antitrypsin deficiency, and Tessera has secured up to $50 million from the Gates Foundation to pursue a globally accessible in vivo gene editing therapy for sickle cell disease. Romanelli previously led Merck’s more than $25 billion international human health business and its fast-growing China business.
Gilead Sciences (Nasdaq: GILD) and Merck (NYSE: MRK) reported detailed Phase 3 ISLEND-1 and ISLEND-2 Week 48 results for the investigational once-weekly oral HIV regimen islatravir 2 mg/lenacapavir 300 mg (ISL/LEN) in virologically suppressed adults who switched from daily antiretroviral therapy.
According to Gilead and Merck, ISL/LEN was noninferior to BIKTARVY in ISLEND-1, with 0% vs 0.3% of participants having HIV-1 RNA ≥50 copies/mL, and noninferior to standard of care in ISLEND-2, with 0.3% vs 1.3% above this threshold. Overall safety, serious adverse events and discontinuations were generally low and similar to comparators, though ISLEND-2 showed a higher rate of treatment-related adverse events with ISL/LEN. CD4+ T-cell counts, lymphocyte counts and body weight remained stable, and ISLEND-2 participants reported higher treatment satisfaction and lower treatment burden. These data will support planned regulatory submissions; ISL/LEN remains investigational and not approved.
Gilead Sciences (Nasdaq: GILD) will present extensive new HIV research at the 26th International AIDS Conference (AIDS 2026) in Rio de Janeiro from July 26-31. Key data include 52-week open-label extension results from the Phase 3 PURPOSE 1 and PURPOSE 2 PrEP trials of twice-yearly lenacapavir, showing continued high efficacy, very high adherence (96% and 92%) and a consistent safety profile with no new signals. PURPOSE 1 recorded zero HIV infections during the extension, while PURPOSE 2 reported one infection among participants continuing lenacapavir. Gilead and Merck (NYSE: MRK) will also present full Phase 3 ISLEND-1 and ISLEND-2 results on a once-weekly investigational islatravir/lenacapavir oral regimen, alongside multiple Biktarvy and long-acting pipeline studies. Gilead highlights progress on its global access strategy for twice-yearly lenacapavir PrEP, expanding its no-profit supply program target from 2 million to up to 3 million people through 2028 and reporting availability in 10 priority sub-Saharan African countries.
Merck (NYSE: MRK) announced U.S. FDA approval of LIPFENDRA (enlicitide) 20 mg tablets as a once-daily oral PCSK9 inhibitor, indicated as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). LIPFENDRA is a novel macrocyclic peptide that binds PCSK9 and blocks its interaction with LDL receptors, and is the first FDA-approved oral PCSK9 inhibitor for LDL-C lowering.
The approval is based on two pivotal Phase 3 CORALreef trials. At week 24, LIPFENDRA reduced LDL-C by 56% versus placebo in CORALreef Lipids and 59% versus placebo in CORALreef HeFH. When biologically impossible baseline LDL-C values were removed post-hoc in CORALreef Lipids, a 60% reduction from baseline was observed with LIPFENDRA versus a 3% increase with placebo. LIPFENDRA also produced statistically significant reductions in non-HDL-C (54% and 52%) and ApoB (50% and 48%) compared to small increases on placebo.
According to Merck, safety in CORALreef Lipids was similar to placebo, while in CORALreef HeFH the most common adverse reactions with higher incidence than placebo were diarrhea (7% vs. 2%) and dizziness (9% vs. 4%), with similar discontinuation rates across arms. An ongoing trial is evaluating effects on cardiovascular morbidity and mortality; it is not yet known if LIPFENDRA reduces these outcomes.
Merck (NYSE: MRK) will present new data across its HIV treatment and prevention pipeline at the 26th International AIDS Conference (AIDS 2026) in Rio de Janeiro, Brazil, from July 26-31, 2026. Late-breaker oral presentations will cover once-weekly investigational oral regimens combining islatravir with lenacapavir (Phase 3 ISLEND-1 and ISLEND-2 trials) and with ulonivirine (Phase 2b MK-8591B-060 trial) in adults with virologically suppressed HIV-1, alongside doravirine/islatravir data up to Week 96. Merck will also host policy and medical symposia on July 29 and hold a virtual HIV Investor Event on August 3, 2026, at 8:00 a.m. ET to update on its HIV strategy.