Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) announced the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended KEYTRUDA, its anti-PD-1 therapy, for treating locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in adults with PD-L1 expression (CPS ≥10) who haven't had prior chemotherapy for metastatic disease. This recommendation is based on positive results from the Phase 3 KEYNOTE-355 trial, which showed significant improvements in progression-free survival and overall survival when KEYTRUDA is combined with chemotherapy. Approval is pending a review by the European Commission.

Merck (NYSE: MRK) announced key data from its oncology research program to be presented at the ESMO Congress 2021, occurring from Sept. 16–21. The highlights include Phase 3 results for KEYTRUDA in stage II melanoma (KEYNOTE-716) and metastatic cervical cancer (KEYNOTE-826), both chosen for the ESMO Presidential Symposium. These trials showed significant improvements in recurrence-free and overall survival, respectively. Merck is committed to advancing treatments for challenging cancers, with a focus on collaborative research for better patient outcomes.

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.