Merck & Co (MRK)

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 KEYTRUDA, Merck’s anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment after surgery for patients with resectable stage II, IIIA, or IIIB 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 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.