Articles from Merck & Co., Inc.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that the National Medical Products Administration (NMPA) of China approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in males 9-26 years of age to help prevent certain HPV-related cancers and diseases. The approval makes GARDASIL the first HPV vaccine approved for use in males in China. GARDASIL is now indicated in China to prevent anal cancers caused by HPV Types 16 and 18, genital warts (condyloma acuminata) caused by HPV Types 6 and 11, and the following precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18: grade 1, grade 2, and grade 3 anal intraepithelial neoplasia (AIN).

Merck (NYSEMRK), known as MSD outside of the United States and Canada, announced today that Robert M. Davis, chairman and chief executive officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, Jan. 13, 2025, at 4:30 p.m. PST / 7:30 p.m. EST.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced the closing of the exclusive global license agreement for LM-299, a novel investigational PD-1/VEGF bispecific antibody, from LaNova Medicines Ltd. As previously announced, Merck will develop, manufacture and commercialize LM-299.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced topline results from two pivotal Phase 3 trials of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir [DOR/ISL (100 mg/0.25 mg)] in adults with HIV-1 infection that is virologically suppressed on different antiretroviral therapy regimens [baseline antiretroviral therapy (bART)]; MK-8591A-051 or bictegravir/emtricitabine/tenofovir alafenamidei [BIC/FTC/TAF (50 mg/200 mg/25 mg)]; MK-8591A-052.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, and Hansoh Pharma, a Chinese biopharmaceutical company, today announced that they have entered into an exclusive global license agreement for HS-10535, an investigational preclinical oral small molecule GLP-1 receptor agonist.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), the company’s investigational prophylactic long-acting monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 10, 2025.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the clinical development programs for vibostolimab, an anti-TIGIT antibody, and favezelimab, an anti-LAG-3 antibody. Vibostolimab is being evaluated as an investigational fixed-dose combination with pembrolizumab (KEYTRUDA®) in the KeyVibe program. Favezelimab is being evaluated as an investigational fixed-dose combination with pembrolizumab in the KEYFORM program.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the conditional approval of WELIREG® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as monotherapy for:

AstraZeneca and Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced long-term results from the OlympiA Phase 3 trial which showed LYNPARZA (olaparib) demonstrated sustained, clinically meaningful improvements in overall survival (OS), invasive disease-free survival (IDFS) and distant disease-free survival (DDFS) for people with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYLYNK-001 trial evaluating KEYTRUDA® (pembrolizumab) plus chemotherapy followed by maintenance with LYNPARZA® (olaparib), with or without bevacizumab, as a first-line treatment for people with BRCA non-mutated advanced epithelial ovarian cancer met its primary endpoint of progression-free survival (PFS). At the final analysis conducted by an independent Data Monitoring Committee, the KEYTRUDA plus LYNPARZA regimen demonstrated a statistically significant and clinically meaningful improvement in PFS for these patients compared to chemotherapy alone.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced the first presentation of data from the Phase 2 waveLINE-007 trial evaluating zilovertamab vedotin, Merck’s investigational antibody drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1), in combination with cyclophosphamide, doxorubicin and prednisone plus rituximab (R-CHP) for the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL). At a pre-planned analysis, zilovertamab vedotin in combination with R-CHP achieved a 100% (n=15) complete response (CR) rate in patients treated with zilovertamab vedotin at 1.75 mg/kg. Based on the data, the study has established 1.75 mg/kg as the recommended Phase 3 dose of zilovertamab vedotin. These data are being presented for the first time today in an oral presentation (Abstract #578) at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced the initiation of the Phase 3 MOVe-NOW clinical trial to evaluate LAGEVRIOTM (molnupiravir), an investigational oral antiviral COVID-19 medicine, for the treatment of adults with COVID-19 at high risk for disease progression. This double-blind, placebo-controlled, global study is enrolling individuals who are at least 18 years of age, tested positive for SARS-CoV-2 infection, have had COVID-19 symptoms for four days or less, and are not hospitalized. Additionally, the study will only enroll adults who cannot receive nirmatrelvir/ritonavir (NMV/r) due to drug-drug interactions, allergy, previous adverse effects, or inaccessibility.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for the treatment of patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations (exon 19 deletion [19del] or exon 21 L858R) whose disease progressed on or after tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy. Sac-TMT is an investigational trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) being developed in collaboration with Kelun-Biotech. This designation is based on data from the Phase 2 expansion cohort of a Phase 1/2 study evaluating sac-TMT in patients with EGFR-mutated NSCLC, which were presented at the 2023 American Society of Clinical Oncology Annual Meeting, as well as data from two parts of a Phase 2 study evaluating sac-TMT in patients with EGFR-mutated NSCLC who have been treated with at least two lines of prior therapy.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, announced today that Robert M. Davis, chairman and chief executive officer, and Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Citi 2024 Global Healthcare Conference on Thursday, Dec. 5, 2024, at 8:00 a.m. EST.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, announced today positive topline results from the Phase 3 ZENITH study evaluating WINREVAIR (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH, WHO* Group 1) functional class (FC) III or IV at high risk of mortality. ZENITH met its primary endpoint of time to first morbidity or mortality event (all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥ 24 hours). In the study, WINREVAIR demonstrated a statistically significant and clinically meaningful reduction in the risk of morbidity or mortality events compared to placebo, both on top of background PAH therapy. Based on the strength of these results, an independent data monitoring committee has recommended ZENITH be stopped early and all participants be offered the opportunity to receive WINREVAIR through the SOTERIA open-label extension study. In preliminary assessment, adverse events and serious adverse events were balanced between the treatment groups.

Merck (NYSEMRK), known as MSD outside the United States and Canada, has been notified that TRC Capital Investment Corporation (TRC Capital) has commenced an unsolicited “mini-tender” offer, dated November 12, 2024, to purchase up to 1,000,000 shares of Merck common stock at $96.38 per share. The offer price is approximately 4.32% below the closing price of the Merck common stock on November 11, 2024 ($100.73), the last trading day before the date of the offer, and approximately 3.48% below the closing price of the Merck common stock on November 21, 2024 ($99.86), the day prior to this release.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, announced today that Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, is scheduled to participate in a fireside chat at the 7th Annual Evercore ISI HealthCONx Conference on Tuesday, Dec. 3, 2024, at 1:20 p.m. EST.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that the National Medical Products Administration (NMPA) in China has approved WELIREG® (belzutifan), for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. WELIREG is a first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor and is the first and only approved HIF-2α inhibitor in China. This approval is based on objective response rate (ORR) and median duration of response (DOR) results from the Phase 2 LITESPARK-004 trial and is the 17th approval of WELIREG for these patients globally.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that Surendralal L. “Lal” Karsanbhai, president and chief executive officer, Emerson Electric Co. NYSE: EMRNYSEEMR)

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that new data for approved and investigational medicines across multiple hematologic malignancies will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego from Dec. 7-10. Data being shared at the meeting will showcase the company’s continued progress in advancing clinical research for Merck’s expanding and diverse pipeline of investigational candidates, with more than 20 abstracts being presented.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, announced today that the Board of Directors has declared a quarterly dividend of $0.81 per share of the company’s common stock for the first quarter of 2025. Payment will be made on Jan. 8, 2025, to shareholders of record at the close of business on Dec. 16, 2024.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced positive topline results from the pivotal Phase 3 MK-3475A-D77 trial. The trial is evaluating the noninferiority of subcutaneous administration of pembrolizumab, Merck’s anti-PD-1 therapy, available for intravenous use as KEYTRUDA®, together with berahyaluronidase alfa, a hyaluronidase variant developed and manufactured by Alteogen Inc. (MK-3475A; “subcutaneous pembrolizumab”), administered with chemotherapy versus intravenous (IV) KEYTRUDA administered with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC).

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable non-epithelioid malignant pleural mesothelioma (MPM).

Merck (NYSEMRK), known as MSD outside of the United States and Canada, announced today that Joseph Romanelli, president, Human Health International, and Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Jefferies London Healthcare Conference on Thursday, Nov. 21, 2024, at 6:30 a.m. EST / 11:30 a.m. GMT.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, and LaNova Medicines Ltd. (LaNova), a privately held clinical-stage biotechnology company, today announced that Merck has entered into an exclusive global license to develop, manufacture and commercialize LM-299, a novel investigational PD-1/VEGF bispecific antibody from LaNova.

Alexion, AstraZeneca Rare Disease and Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 KOMET trial, which is the largest, global randomized double-blind placebo-controlled multicenter Phase 3 trial in adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). Topline results showed that KOSELUGO, an oral, selective MEK inhibitor, demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR), the study’s primary endpoint, versus placebo, in these adult patients.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that new clinical and real-world data for the company’s 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), evaluating the burden and incidence of certain HPV-related cancers and diseases, will be presented at the International Papillomavirus Conference (IPVC) 2024 in Edinburgh, UK, from November 12-15.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, announced today that Jannie Oosthuizen, president, Human Health U.S., and Dr. Joerg Koglin, senior vice president and head of general medicine, global clinical development, Merck Research Laboratories, are scheduled to participate in a fireside chat at the UBS Global Healthcare Conference on Wednesday, Nov. 13, 2024, at 12:30 p.m. EST / 9:30 a.m. PST.

Merck (NYSEMRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2024.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, and Moderna, Inc. (Nasdaq: MRNA), today announced the initiation of INTerpath-009, a pivotal Phase 3 randomized clinical trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, as adjuvant treatment for patients with resectable Stage II, IIIA or IIIB (N2) non-small cell lung cancer (NSCLC) who did not achieve a pathological complete response (pCR) after receiving neoadjuvant KEYTRUDA plus platinum-based chemotherapy. Global recruitment in INTerpath-009 has begun, and the first patients have now started enrolling in Canada.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved two new indications for KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in gynecologic cancers. The first approval is for KEYTRUDA, in combination with carboplatin and paclitaxel, for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy. The second approval is for KEYTRUDA, in combination with chemoradiotherapy (CRT), for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy. With these decisions, KEYTRUDA is now approved for 30 indications in the EU, including five in gynecologic cancers – three in endometrial cancer and two in cervical cancer.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted to update the adult age-based pneumococcal vaccination guidelines and recommends CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for pneumococcal vaccination in adults 50 years of age and older.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced the presentation of positive results from the Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab, the company’s investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. The results, along with interim findings from the ongoing Phase 3 trial (MK-1654-007) of clesrovimab, were presented during IDWeek 2024, held October 16-19 in Los Angeles, California.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced results from STRIDE-8, a Phase 3 trial evaluating CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine), at IDWeek 2024 in Los Angeles, California. The trial evaluated the immunogenicity, safety and tolerability of CAPVAXIVE compared to PCV15 (pneumococcal 15-valent conjugate vaccine) in combination with PPSV23 (pneumococcal 23-valent polysaccharide vaccine) in vaccine-naïve adults 18-64 years of age with certain chronic conditions that put them at an increased risk of pneumococcal disease.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced its plans to present new research findings demonstrating the continued impact of its increasingly broad and diverse vaccines and infectious disease portfolio and the potential of its innovative pipeline at IDWeek 2024 in Los Angeles, CA, from October 16-19.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-689 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, as a perioperative treatment for patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell carcinoma (LA-HNSCC) met its primary endpoint of event-free survival (EFS). The study evaluated KEYTRUDA as neoadjuvant therapy, then continued after surgery in combination with standard-of-care radiotherapy (with or without cisplatin) as adjuvant therapy, followed by KEYTRUDA as maintenance therapy, compared to adjuvant radiotherapy (with or without cisplatin) alone. At a pre-specified first interim analysis conducted by an independent Data Monitoring Committee, there was a statistically significant and clinically meaningful improvement in EFS for patients receiving the KEYTRUDA perioperative treatment regimen. The study also showed a statistically significant improvement in major pathological response (mPR), a key secondary endpoint, for patients in the KEYTRUDA arm compared with adjuvant radiotherapy alone. The safety profile of KEYTRUDA was consistent with that observed in previously reported studies; no new safety signals were identified.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced the completion of the acquisition of CN201 from Curon Biopharmaceutical (Curon), a novel investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, will hold its third-quarter 2024 sales and earnings conference call with institutional investors and analysts at 9:00 a.m. ET on Thursday, October 31. During the call, company executives will provide an overview of Merck’s performance for the quarter.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that new data highlighting the long-term efficacy and safety of tulisokibart (MK-7240), an investigational humanized monoclonal antibody directed to a novel target, tumor necrosis factor (TNF)-like cytokine 1A (TL1A), in ulcerative colitis (UC) and Crohn’s disease (CD) will be presented at the United European Gastroenterology (UEG) Week 2024 Congress in Vienna, Austria.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYFORM-007 trial evaluating the investigational fixed-dose combination of favezelimab, Merck’s anti-LAG-3 antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, did not meet its primary endpoint of overall survival (OS) for the treatment of patients with previously treated PD-L1 positive microsatellite stable (MSS) metastatic colorectal cancer (mCRC). At the final pre-specified analysis, the favezelimab and pembrolizumab fixed-dose combination did not demonstrate an improvement in OS compared to standard of care (regorafenib or TAS-102 [trifluridine and tipiracil hydrochloride]). The safety profile of the fixed-dose combination was consistent with that observed for favezelimab and pembrolizumab in previously reported studies, with no new safety signals observed.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved new indications for KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in certain lung and urothelial cancers:

Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSEMRK), announced today the expansion of the newly USDA-approved NOBIVAC® NXT vaccine platform to include a best in class solution to protect cats against one of the most common feline infectious diseases, feline leukemia virus (FeLV). The vaccine is expected to be available at veterinary clinics and hospitals nationwide this fall.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending approval of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for two indications in gynecologic cancers. The first opinion recommends the approval of KEYTRUDA in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma who are candidates for systemic therapy. The second positive opinion recommends the approval of KEYTRUDA in combination with chemoradiotherapy (CRT) for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy. The CHMP’s recommendations will now be reviewed by the European Commission for marketing authorization in the European Union (EU), and final decisions are expected in the fourth quarter of 2024.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced the first-time presentation of overall survival (OS) results from the Phase 3 KEYNOTE-522 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy as pre-operative (neoadjuvant) treatment and then continuing as a single agent after surgery (adjuvant) for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC). After a median follow-up of 75.1 months (range, 65.9-84.0), the KEYTRUDA regimen significantly improved OS, a key secondary endpoint, reducing the risk of death by 34% (HR=0.66 [95% CI, 0.50-0.87]; p=0.0015) in patients with high-risk early-stage TNBC compared to the chemotherapy-placebo regimen (placebo plus chemotherapy followed by placebo after surgery). The five-year OS rate was 86.6% (95% CI, 84.0-88.8) for patients who received the KEYTRUDA regimen versus 81.7% (95% CI, 77.5-85.2) for patients who received the chemotherapy-placebo regimen. Median OS was not reached in either group. The safety profile of KEYTRUDA was consistent with that observed in previously reported studies with no new safety signals observed.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced long-term overall survival (OS) data from the pivotal Phase 3 KEYNOTE-006 trial, evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced melanoma. Based on 10 years of follow-up, the data showed sustained improved survival outcomes for patients receiving KEYTRUDA as a single agent compared to ipilimumab in patients with advanced melanoma. These late-breaking data will be presented for the first time today during a mini oral session at the European Society for Medical Oncology (ESMO) Congress 2024 (presentation #LBA44) and published in the Annals of Oncology.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, and Eisai today announced results from the first interim analysis of the Phase 3 LEAP-012 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, in combination with transarterial chemoembolization (TACE) compared to TACE alone for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma (HCC). These late-breaking data are being presented for the first time today during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2024 (Presentation #LBA3).

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced the first presentation of overall survival (OS) results from the pivotal Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with concurrent chemoradiotherapy (CRT) for newly diagnosed patients with high-risk (stage IB2-IIB with lymph node-positive disease and stage III-IVA with and without lymph node-positive disease) locally advanced cervical cancer. At a median follow-up of 29.9 months (range, 12.8-43.0), KEYTRUDA in combination with concurrent CRT reduced the risk of death by 33% (HR=0.67 [95% CI, 0.50-0.90]; p=0.0040) versus concurrent CRT alone for these patients. These data were selected for the official Press Briefing and are being presented for the first time today during a Presidential Symposium session at the European Society for Medical Oncology (ESMO) Congress 2024 (Presentation #709O) and published simultaneously in The Lancet.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced overall survival (OS) results from the final analysis of the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. These data are being presented today during a proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2024 (Presentation #1400O) and are also being simultaneously published in the New England Journal of Medicine.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, announced today that Joseph Romanelli, president, Human Health International, is scheduled to participate in a fireside chat at the Bank of America 2024 Global Healthcare Conference on Wednesday, Sept. 18, 2024, at 6:40 a.m. EDT / 11:40 a.m. BST.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced positive top-line results from its pivotal Phase 3 trial (V503-064) evaluating the company’s 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) in Japanese males ages 16 to 26 years. The trial met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen of GARDASIL 9 reduced the combined incidence of anogenital persistent infection caused by 9 types of HPV compared with a placebo.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that new data for four approved medicines and six pipeline candidates in more than 20 types of cancer will be presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, from Sept. 13-17. Study findings from the Phase 3 KEYNOTE-522 trial (#LBA4) in high-risk early-stage triple-negative breast cancer (TNBC), the Phase 3 KEYNOTE-A18 trial (#709O) in high-risk locally advanced cervical cancer and the Phase 3 LEAP-012 trial (#LBA3) in unresectable, non-metastatic hepatocellular carcinoma, in collaboration with Eisai, have been selected for the ESMO Presidential Symposium Sessions. Data being shared at the Congress showcase the company’s continued progress in advancing clinical research for Merck’s broad portfolio and diverse pipeline of investigational candidates, with a total of 80 abstracts being presented.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, and EyeBio, a wholly-owned subsidiary of Merck & Co., Inc., Rahway, N.J., USA, today announced the initiation of the Phase 2b/3 BRUNELLO trial evaluating Restoret™ (MK-3000, formerly EYE103) for the treatment of diabetic macular edema (DME).

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults. The decision follows the adoption of the European Society for Medical Oncology and European Association of Urology clinical guidelines recommending the combination as the preferred first-line treatment for these patients, regardless of platinum eligibility.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, announced today that Robert M. Davis, chairman and chief executive officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Morgan Stanley 22nd Annual Global Healthcare Conference on Thursday, Sept. 5, 2024, at 2:35 p.m. EDT.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today provided updates on two Phase 3 trials, KEYNOTE-867 and KEYNOTE-630. Merck is discontinuing the Phase 3 KEYNOTE-867 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with stereotactic body radiotherapy (SBRT) for the treatment of patients with stage I or II (stage IIB N0, M0) non-small cell lung cancer (NSCLC), including those who are medically inoperable or have refused surgery. This decision is based on the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis. At the pre-specified interim analysis, KEYTRUDA in combination with SBRT did not demonstrate an improvement in event-free survival (EFS) or overall survival (OS), the study’s primary endpoint and key secondary endpoint, respectively, compared to placebo plus SBRT, and the benefit/risk profile of the combination did not support continuing the trial. KEYTRUDA in combination with SBRT was associated with higher rates of adverse events (AEs), including AEs leading to death, compared with SBRT and placebo.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced the initiation of Shorespan-007, a pivotal Phase 3 clinical trial evaluating bomedemstat, an investigational orally available lysine-specific demethylase 1 (LSD1) inhibitor, for the treatment of patients with essential thrombocythemia (ET) who have previously not received cytoreductive therapy. Essential thrombocythemia is a chronic, rare blood disorder and is the most common type of myeloproliferative neoplasm. Global recruitment of the Shorespan-007 trial has begun, with patients now enrolling.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with World Health Organization (WHO) Functional Class (FC) II to III, to improve exercise capacity. WINREVAIR is the first and only activin signaling inhibitor therapy for PAH approved in all 27 member states of the EU, as well as Iceland, Liechtenstein and Norway. WINREVAIR works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH. The EC approval of WINREVAIR is based on safety and efficacy results from the Phase 3 STELLAR trial.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, and Curon Biopharmaceutical (Curon), a privately held biotechnology company, today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, has agreed to acquire CN201, a novel investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the Phase 3 KeyVibe-008 trial based on the recommendation of an independent Data Monitoring Committee (DMC). The trial is evaluating the investigational fixed-dose combination (coformulation) of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, in combination with chemotherapy compared to atezolizumab in combination with chemotherapy, for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). At a pre-planned analysis, data showed that the primary endpoint of overall survival (OS) met the pre-specified futility criteria. Additionally, when compared to patients in the control arm, patients in the vibostolimab and pembrolizumab fixed-dose combination arm experienced a higher rate of adverse events (AEs) and immune-related AEs. A comprehensive analysis of this study is ongoing.

Merck (NYSEMRK), known as MSD outside the United States and Canada, today announced financial results for the second quarter of 2024.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, announced today that the Board of Directors has declared a quarterly dividend of $0.77 per share of the company’s common stock for the fourth quarter of 2024. Payment will be made on Oct. 7, 2024, to shareholders of record at the close of business on Sept. 16, 2024.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced positive topline results from its Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab (MK-1654), the company’s investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease. In the trial, clesrovimab met its primary safety and efficacy endpoints, including reducing medically attended lower respiratory infections (MALRI) caused by RSV through Day 150. Detailed findings of the study will be presented at an upcoming scientific congress and Merck plans to file these data with global regulatory authorities.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced upcoming data presentations and programming at the 25th International AIDS Conference (AIDS 2024), taking place July 22-26, 2024, in Munich, Germany. Merck will share updates on new scientific findings from its HIV research program, including Phase 1 results from a trial evaluating the potential for drug-drug interaction between MK-8527, the company’s novel nucleoside reverse transcriptase translocation inhibitor (NRTTI), and an oral contraceptive. The company will also host a symposium exploring HIV-related stigma and discrimination, as well as a symposium on the importance of choice when considering HIV treatment and prevention options.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced the completion of the acquisition of Eyebiotech Limited (EyeBio). EyeBio is now a wholly-owned subsidiary of Merck.

Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSEMRK), today announced the completion of its acquisition of the aqua business of Elanco Animal Health Incorporated NYSE: ELANNYSEELAN)

Merck (NYSEMRK), known as MSD outside of the United States and Canada, and Orion Corporation (“Orion”) today announced that notice has been provided of the mutual exercise of an option to convert the companies’ ongoing co-development and co-commercialization agreement for opevesostat (MK-5684/ODM-208), an investigational CYP11A1 inhibitor, and other candidates targeting CYP11A1 into an exclusive global license for Merck.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, will hold its second-quarter 2024 sales and earnings conference call with institutional investors and analysts at 9:00 a.m. ET on Tuesday, July 30. During the call, company executives will provide an overview of Merck’s performance for the quarter.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) as an option for adults 65 years of age and older for pneumococcal vaccination.

Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSEMRK), announced today the U.S. Department of Agriculture (USDA) approval of NOBIVAC® NXT Canine Flu H3N2, a next-level solution to help safeguard dogs against the ongoing threat of canine influenza. The product is expected to be available at veterinary clinics and hospitals nationwide late this summer.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for:

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. This approval marks the third endometrial carcinoma indication and the 40th indication overall for KEYTRUDA in the U.S.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, announced today that Robert M. Davis, chairman and chief executive officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024, at 10:00 a.m. EDT.

Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy, for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of September 25, 2024.