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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) presented a systematic literature review at IDWeek 2025 summarizing 15 U.S. studies (2015–2025) and CDC ABC surveillance on pneumococcal serotypes targeted by CAPVAXIVE (21‑valent) versus PCV20. The review found CAPVAXIVE‑unique serotypes were more prevalent in U.S. adults with pneumococcal disease and showed higher antimicrobial resistance in some serotypes.
Key figures: in adults ≥65 years, CAPVAXIVE‑unique serotypes accounted for 34.8% of invasive disease vs 8.5% for PCV20‑unique; ages 50–64: ~30% vs ~15%. Reported resistance included serotype 35B (penicillin 96%, erythromycin 89%) and 23A (penicillin 72%, erythromycin 46%); multidrug resistance was highest for 19F (42%) and 23A (27%). CAPVAXIVE is indicated for adults ≥18 and reportedly covers ~84% of IPD in adults 50+ vs ~52% for PCV20 (CDC ABC 2018–2022).
Merck (NYSE: MRK) reported long-term analyses showing sustained survival benefit for KEYTRUDA (pembrolizumab) in non-small cell lung cancer (NSCLC) across earlier and advanced stages, presented at ESMO Congress 2025.
KEYNOTE-671 five-year exploratory follow-up showed improved overall survival (HR=0.74) and event-free survival (HR=0.58) for perioperative KEYTRUDA plus chemotherapy versus chemotherapy-placebo, with five-year OS rates of 64.6% versus 53.6% and five-year EFS rates of 49.9% versus 26.5%. Long-term (8–10 year) follow-ups of KEYNOTE-001/010/024/042 also showed durable OS benefits versus chemotherapy in selected PD-L1 populations.
Merck (NYSE: MRK) broke ground on a $3 billion, 400,000-square-foot Center of Excellence for Pharmaceutical Manufacturing at its Elkton, Virginia site on October 20, 2025. The facility will house Active Pharmaceutical Ingredient and Drug Product capabilities for small molecule manufacturing and testing and is expected to potentially create more than 500 full-time roles plus 8,000 construction jobs.
This project is part of a broader plan to invest more than $70 billion beginning in 2025 to expand U.S. manufacturing and R&D; Merck also cited nearly $6 billion in U.S. manufacturing investments announced in 2025 and forecasts 48,000+ construction-related jobs by 2029.
Merck (NYSE: MRK) and Daiichi Sankyo reported Phase 2 REJOICE-Ovarian01 results for raludotatug deruxtecan in platinum-resistant ovarian, primary peritoneal and fallopian tube cancer (data cut-off Feb 26, 2025).
Key outcomes: a confirmed objective response rate of 50.5% (n=107) across three doses, disease control rate 77.6%, and median time to response ~7.1 weeks. The 5.6 mg/kg dose was selected for Phase 3. Safety: common TEAEs included nausea, anemia, asthenia and neutropenia; 3.7% had treatment-related ILD/pneumonitis. R-DXd received Breakthrough Therapy Designation from FDA in Sept 2025.
Merck (NYSE: MRK) reported first and second interim results from the Phase 3 KEYNOTE-B96 trial in platinum-resistant recurrent ovarian cancer presented at ESMO 2025.
Key clinical results: at 15.6-month median follow-up KEYTRUDA+chemotherapy ± bevacizumab reduced risk of progression or death by 30% (HR=0.70) in all comers; 12-month PFS 33.1% vs 21.3%. At 26.6-month follow-up KEYTRUDA reduced risk of death by 24% (HR=0.76) in PD-L1 CPS≥1 patients; 12-month OS 69.1% vs 59.3% and 18-month OS 51.5% vs 38.9%.
Safety signals included higher Grade 3–5 TRAEs (67.5% vs 55.3%) and immune-mediated AEs (39.1% vs 18.9%). The FDA accepted an sBLA for priority review with a PDUFA date of Feb 20, 2026.
Merck (NYSE: MRK) reported Phase 3 KEYNOTE-905/EV-303 results showing perioperative KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin) reduced the risk of event-free survival (EFS) events by 60% (HR=0.40; p<0.0001) and reduced the risk of death by 50% (HR=0.50; p=0.0002) versus surgery alone in cisplatin-ineligible or -declining muscle-invasive bladder cancer (MIBC) patients after a median follow-up of 25.6 months.
Median EFS was not reached for the combination versus 15.7 months for surgery alone. Pathologic complete response (pCR) rose to 57.1% with the combination versus 8.6% with surgery (increase of 48.3 percentage points; p<0.000001). Safety showed higher treatment-emergent adverse events with the combination (100% vs 64.8%; Grade ≥3: 71.3% vs 45.9%). Results were presented at ESMO 2025 and the companies plan to share data with regulators worldwide.
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.