Welcome to our dedicated page for Merck & Co news (Ticker: MRK), a resource for investors and traders seeking the latest updates and insights on Merck & Co stock.
Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada, generates frequent news across human health, animal health and corporate finance. As a research-intensive biopharmaceutical company with more than a century of history developing medicines and vaccines, Merck regularly announces clinical trial milestones, regulatory decisions, business development transactions and capital markets activity.
Recent news highlights include oncology updates from Merck’s extensive KEYTRUDA program, such as positive Phase 3 data in muscle-invasive bladder cancer and new trials in non-small cell lung cancer using combinations like calderasib (MK-1084) with KEYTRUDA QLEX. The company also reports on progress in other therapeutic areas, including pulmonary arterial hypertension with WINREVAIR, Alzheimer’s disease candidates MK-2214 and MK-1167, and cardiovascular research with the oral PCSK9 inhibitor candidate enlicitide.
Investors following MRK news will also see announcements related to Merck Animal Health, such as the conditional U.S. FDA approval of EXZOLT CATTLE-CA1 for the prevention and treatment of New World screwworm larvae and the treatment and control of cattle fever tick, as well as updates on acquisitions like the planned merger with Cidara Therapeutics to add the influenza candidate CD388 to Merck’s respiratory portfolio.
Corporate and financial communications include quarterly earnings calls, participation in major healthcare conferences and disclosures about note offerings under the company’s shelf registration statement. This news page aggregates these developments so readers can review clinical, regulatory, strategic and financial updates related to Merck & Co., Inc. and its MRK stock in one place.
On September 13, 2021, Merck (NYSE: MRK) will participate in a virtual fireside chat at the Morgan Stanley 19th Annual Conference at 11:00 a.m. EDT. Rob Davis, CEO, and Dr. Dean Li, President of Merck Research Laboratories, will represent the company. Interested parties can watch the live video webcast at Merck's investor website. Merck has been innovating for 130 years, focusing on vaccines and medicines for critical diseases globally.
Merck (NYSE: MRK) announced that KEYTRUDA has been approved in China for first-line treatment of advanced esophageal and gastroesophageal junction cancers. This groundbreaking approval allows for the use of KEYTRUDA in combination with chemotherapy, based on positive outcomes from the Phase 3 KEYNOTE-590 trial, which showed a 27% reduction in the risk of death and a 35% reduction in disease progression compared to chemotherapy alone. With this indication, KEYTRUDA is now approved for eight indications across five cancer types in China.
Merck (NYSE: MRK) and Ridgeback Biotherapeutics have launched the Phase 3 MOVe-AHEAD clinical trial to assess molnupiravir, an oral antiviral for COVID-19 prevention. The study targets individuals 18 and older living with someone confirmed to have symptomatic COVID-19. Approximately 1,332 participants will receive molnupiravir or placebo for five days. The trial aims to reduce COVID-19 incidence and is part of ongoing evaluations of molnupiravir's efficacy. Results from a related study, MOVe-OUT, are expected in the latter half of 2021.
Merck (NYSE: MRK) announced the FDA's full approval of KEYTRUDA for treating patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for platinum-containing chemotherapy. The update shifts from accelerated approval and includes a revised indication. Despite the failure of the KEYNOTE-361 trial to meet dual primary endpoints, the FDA’s advisory committee voted to maintain accelerated approval. KEYTRUDA also holds indications for various stages of bladder cancer, highlighting Merck's commitment to advancing treatment options.
Merck (NYSE: MRK) announced that KEYTRUDA has received two approvals from Japan's Pharmaceuticals and Medical Devices Agency. The first approval allows its use in treating PD-L1-positive, hormone receptor-negative, and HER2-negative, inoperable or recurrent breast cancer, based on the KEYNOTE-355 trial results. The second approval is for unresectable, advanced, or recurrent high microsatellite instability colorectal cancer, based on KEYNOTE-177 results. KEYTRUDA now has 15 authorized uses in Japan, supporting the company's commitment to cancer care.
Merck (NYSE: MRK) announced positive topline results from the pivotal PNEU-PED (V114-029) study, evaluating the safety and immunogenicity of VAXNEUVANCE, a 15-valent pneumococcal conjugate vaccine, in infants aged 42-90 days. The study showed that VAXNEUVANCE had a safety profile comparable to PCV13, meeting primary endpoints for immunogenicity after 3 and 4 doses. Additionally, VAXNEUVANCE demonstrated superior immune responses for specific serotypes. The Phase 3 PNEU-LINK study also confirmed the vaccine's favorable safety profile, with full results to be shared at a scientific congress.
Merck (NYSE: MRK) announced the resignation of Leslie A. Brun, its independent lead director, effective August 19, 2021. Brun is stepping down to become chairman and CEO of Ariel Alternatives, a private equity initiative focused on scaling minority-owned businesses as tier 1 suppliers to Fortune 500 companies. Merck is considering an investment in Ariel Alternatives. CEO Rob Davis acknowledged Brun's contributions and expressed support for his new role. The company plans to appoint a new independent lead director soon.
Merck (NYSE: MRK) has received FDA approval for WELIREG, an oral HIF-2α inhibitor, to treat adult patients with von Hippel-Lindau (VHL) disease requiring therapy for associated renal cell carcinoma (RCC), central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors (pNET). This approval marks WELIREG as the first systemic therapy for certain VHL-associated tumors in the U.S. The treatment showed a significant overall response rate (ORR) of 49% in RCC patients and is vital for addressing an unmet medical need.
Merck and Eisai announced FDA approval for the combination of KEYTRUDA and LENVIMA as a first-line treatment for advanced renal cell carcinoma (RCC). This decision is based on results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, which showed significant improvements in progression-free survival (PFS) and overall survival (OS) compared to sunitinib. KEYTRUDA plus LENVIMA reduced disease progression or death by 61%, with median PFS of 23.9 months versus 9.2 months for sunitinib. 71% of patients achieved confirmed objective response rate, indicating strong efficacy for this cancer therapy.
Merck (NYSE: MRK) announced that the FDA has accepted its supplemental Biologics License Application for KEYTRUDA, targeting advanced endometrial carcinoma with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) characteristics. This application stems from data from KEYNOTE-158, which will be discussed at the upcoming ESMO Congress. The FDA's target action date is March 28, 2022. KEYTRUDA has previously received accelerated approval for similar cancer indications and is part of Merck's expanding oncology portfolio, aimed at addressing challenging women's cancers.