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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 Eisai reported five-year results from the Phase 3 KEYNOTE-775/Study 309 trial showing durable survival benefit for KEYTRUDA (pembrolizumab) plus LENVIMA (lenvatinib) versus chemotherapy in advanced endometrial carcinoma after prior platinum therapy.
In the pMMR subgroup at median follow-up 68.8 months, five-year OS was 16.7% vs 7.3%, median OS 18.0 vs 12.2 months (HR 0.70). All-comers five-year OS was 19.9% vs 7.7%, median OS 18.7 vs 11.9 months (HR 0.66). Safety was consistent with prior data; no new signals.
Merck (NYSE: MRK) announced that the Phase 3 KEYNOTE-B96 trial met its secondary endpoint of overall survival (OS) in all comers with platinum-resistant recurrent ovarian cancer when KEYTRUDA (pembrolizumab) was added to paclitaxel with or without bevacizumab.
The regimen previously met the primary endpoint of progression-free survival (PFS) and earlier OS analyses in PD-L1–expressing tumors; the final analysis showed a statistically significant and clinically meaningful OS benefit in all comers. Safety was consistent with prior studies and no new safety signals were identified. Final results will be presented at an upcoming medical meeting.
Merck (NYSE: MRK) presented additional Phase 3 data for the investigational once-daily oral two-drug regimen DOR/ISL (100 mg/0.25 mg) in adults with virologically suppressed HIV-1. Data showed minimal changes in weight and body composition at Week 48 and no clinically meaningful effects on fasting lipids or HOMA-IR, comparable to participants who continued BIC/FTC/TAF or baseline ART. In MK-8591A-052, mean weight change at Week 48 was −0.03 kg for DOR/ISL vs +0.28 kg for BIC/FTC/TAF; 14.6% of DOR/ISL participants had ≥5% weight gain. The FDA accepted the NDA for DOR/ISL with a PDUFA target action date of April 28, 2026.
Merck (NYSE: MRK) will present new HIV treatment and prevention data at the 20th European AIDS Conference (EACS) in Paris, Oct. 15–18, 2025. Presentations include Week 48 weight and body composition results from the Phase 3 MK-8591A-052 trial comparing doravirine/islatravir (DOR/ISL 100mg/0.25mg) vs bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), Week 48 fasting lipids and insulin resistance analyses from MK-8591A-051 and MK-8591A-052, 96-week safety and PK data from the Phase 2 weekly islatravir+lenacapavir study (NCT05052996), and Phase 1 PK/safety of monthly MK-8527 in renal impairment. The company noted DOR/ISL is under FDA review. Merck will also host policy and medical symposia on Oct. 16 and Oct. 17 open to registered attendees.
Merck (NYSE: MRK) will present more than 100 abstracts across 20+ cancer types at ESMO Congress 2025 (Oct 17–21) in Berlin. Key highlights include first-time Phase 3 data from KEYNOTE-905 (enfortumab vedotin + pembrolizumab) and KEYNOTE-B96 (pembrolizumab ± bevacizumab) featured in Presidential Symposium sessions.
Long-term follow-up includes 5‑year and 10‑/8‑year exploratory results for pembrolizumab in multiple lung and endometrial studies. Multiple investigational ADCs (R-DXd, I-DXd, sac-TMT) and other pipeline candidates will have clinical updates.
Merck (NYSE: MRK) completed the acquisition of Verona Pharma on October 7, 2025, acquiring all ADS for $107 per ADS (each ADS = eight ordinary shares) for a total transaction value of approximately $10 billion. Verona Pharma becomes a wholly owned Merck subsidiary and its ADS will no longer trade on Nasdaq.
The deal adds Ohtuvayre (ensifentrine)—an FDA‑approved (June 2024) first‑in‑class inhaled maintenance treatment for COPD—to Merck’s cardio‑pulmonary portfolio, and Ohtuvayre is being evaluated in bronchiectasis trials. Merck expects most of the purchase price to be capitalized as an intangible asset and amortized for GAAP purposes, and estimates a ~$0.16 negative impact on non‑GAAP EPS in the first 12 months related to financing costs partially offset by Ohtuvayre performance.
Merck (NYSE: MRK) announced on October 6, 2025 the initiation of three Phase 2b trials of tulisokibart (MK-7240) in hidradenitis suppurativa, radiographic axial spondyloarthritis, and rheumatoid arthritis.
According to the press release, global recruitment has begun with a target enrollment of more than 640 patients across the three studies (MK-7240-12, MK-7240-013, MK-7240-014). The company notes tulisokibart is already in Phase 3 trials for ulcerative colitis and Crohn’s disease and in a Phase 2 study for systemic sclerosis-associated interstitial lung disease, bringing the program to investigation in six diseases.
Merck (NYSE: MRK) has scheduled its third-quarter 2025 sales and earnings conference call for Thursday, October 30, 2025, at 9:00 a.m. ET. The call will feature company executives presenting an overview of Merck's quarterly performance.
Institutional investors, analysts, media, and the public can access the live audio webcast through a provided weblink. A replay of the webcast, earnings release, supplemental financial disclosures, and results presentation slides will be available on www.merck.com. Participants can also join via phone using the toll-free numbers (800) 369-3351 for U.S. and Canada or (517) 308-9448 with access code 9818590.
Merck (NYSE:MRK) announced positive Phase 3 HYPERION trial results for WINREVAIR™ (sotatercept-csrk) in recently diagnosed pulmonary arterial hypertension (PAH) patients. The study demonstrated that WINREVAIR reduced clinical worsening events risk by 76% compared to placebo in combination with background therapy.
Key findings include: 10.6% of WINREVAIR-treated patients versus 36.9% in the placebo group experienced clinical worsening events. The trial showed 29.4% of treated patients achieved multicomponent improvement, and 60.1% maintained or achieved a low REVEAL LITE 2 score. The safety profile remained consistent with previous trials, with adverse events occurring in 89.4% of WINREVAIR patients versus 90.0% in the placebo group.
Merck (NYSE: MRK) has received FDA approval for KEYTRUDA QLEX™, the first subcutaneously administered immune checkpoint inhibitor. This groundbreaking treatment can be administered in as little as one minute, compared to the traditional 30-minute IV infusion of KEYTRUDA.
The approval covers 38 solid tumor indications and is supported by a pivotal trial in non-small cell lung cancer (NSCLC) patients. The trial demonstrated comparable results between KEYTRUDA QLEX and IV KEYTRUDA, with similar overall response rates of 45% vs 42% respectively, and no notable differences in progression-free survival and overall survival.
KEYTRUDA QLEX will be available in the U.S. by late September 2025, offering flexible dosing options of either one-minute administration every three weeks or two-minute administration every six weeks, with injection sites in the thigh or abdomen.