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. (NYSE: MRK) is a global pharmaceutical leader with a 350-year legacy of medical innovation. This news hub provides investors and healthcare professionals with direct access to official announcements, financial disclosures, and research developments shaping the company's trajectory.
Track MRK's latest regulatory milestones, clinical trial results, and strategic partnerships through verified press releases and curated analysis. Our repository includes earnings call transcripts, FDA approval updates, and global health initiatives—all organized for efficient research and due diligence.
Key updates on therapeutic advancements in oncology, vaccines, and infectious diseases are maintained alongside financial performance data. Bookmark this page for real-time access to Merck's corporate communications and market-moving developments in the pharmaceutical sector.
Merck (NYSE: MRK) has announced a pause in enrollment for the Phase 3 clinical studies IMPOWER 22 and IMPOWER 24, which evaluate the investigational drug islatravir for pre-exposure prophylaxis against HIV-1. This decision follows recommendations from an external data monitoring committee. However, participants already enrolled will continue receiving the study medication. Merck will enhance monitoring measures for participants during this period. The company remains committed to addressing unmet needs in HIV treatment and prevention.
Merck (NYSE: MRK) has received FDA approval for KEYTRUDA as an adjuvant treatment for pediatric and adult patients with completely resected stage IIB and IIC melanoma. This decision is based on KEYTRUDA's performance in the Phase 3 KEYNOTE-716 trial, demonstrating a 35% reduction in the risk of disease recurrence or death compared to placebo. After 14.4 months, 11% of patients treated with KEYTRUDA experienced recurrence, compared to 17% for the placebo group. This approval expands treatment options for patients at high risk of recurrence following surgery.
Merck (NYSE: MRK) announced that the FDA has accepted for Priority Review its supplemental Biologics License Application for VAXNEUVANCE, a 15-valent pneumococcal conjugate vaccine. This vaccine aims to prevent invasive pneumococcal disease in children aged 6 weeks to 17 years. The priority review indicates significant potential for improved safety and effectiveness. The FDA set a target action date of April 1, 2022. Clinical studies suggest it will broaden coverage against critical pneumococcal strains, addressing a considerable disease burden in children.
Merck (NYSE: MRK) and Ridgeback Biotherapeutics received a positive vote from the FDA's Antimicrobial Drugs Advisory Committee, recommending Emergency Use Authorization (EUA) for molnupiravir (MK-4482), an oral antiviral for treating mild to moderate COVID-19 in high-risk adults. The committee voted 13-10, asserting the benefits outweigh risks. Data from the MOVe-OUT study showed molnupiravir reduced hospitalization or death by approximately 50%. Merck is gearing up for production and aims for broad access to molnupiravir globally.
Merck (NYSE: MRK) has declared a quarterly dividend of
Merck's KEYTRUDA has been approved by Japan's PMDA as a first-line treatment for advanced esophageal cancer in combination with chemotherapy (5-FU and cisplatin). This marks KEYTRUDA's 16th indication in Japan. The approval is based on the Phase 3 KEYNOTE-590 trial, which showed a 27% reduction in death risk and a 35% reduction in disease progression compared to standard chemotherapy. Esophageal cancer poses a significant health burden in Japan, with over 26,000 new cases annually. Merck continues to expand KEYTRUDA's applications in various gastrointestinal cancers.
Merck (NYSE: MRK) and AstraZeneca announced the acceptance of a supplemental New Drug Application for LYNPARZA, targeting BRCA mutations in early-stage HER2-negative breast cancer. The FDA granted priority review, with a target action date in Q1 2022. The application was based on the Phase 3 OlympiA trial, showing a 42% reduction in the risk of invasive breast cancer recurrence. LYNPARZA is already approved for several cancer indications, and its safety profile aligns with previous trials, with common adverse events including nausea and fatigue.
Merck (NYSE: MRK) and Eisai announced the European Commission's approval of KEYTRUDA and LENVIMA for treating advanced or recurrent endometrial carcinoma in adults. This is the first combination of an immunotherapy with a tyrosine kinase inhibitor approved in Europe for patients who have seen disease progression after platinum-based therapies and are not surgical candidates.
The decision is based on the pivotal Phase 3 KEYNOTE-775/Study 309, showing a 38% reduction in death risk and a 44% reduction in disease progression risk compared to chemotherapy.
Merck (NYSE: MRK) and Eisai announced that the European Commission has approved the combination therapy of KEYTRUDA and LENVIMA for treating advanced renal cell carcinoma (RCC). This decision follows results from the CLEAR/KEYNOTE-581 trial, showing that this combination reduced the risk of disease progression or death by 61% compared to sunitinib, with a median progression-free survival of 23.9 months. The combination also showed an overall survival benefit and a higher objective response rate, providing new hope for advanced RCC patients in Europe.
Merck (NYSE: MRK) and Ridgeback Biotherapeutics have released data from the MOVe-OUT study of molnupiravir, an oral antiviral for COVID-19. The study, involving 1,433 participants, showed a reduction in hospitalization or death rates from 9.7% in the placebo group to 6.8% in the treatment group, achieving a 30% relative risk reduction. The FDA is reviewing Merck's Emergency Use Authorization application, with discussions scheduled for Nov. 30. Previously, an interim analysis had indicated even greater efficacy, reducing risks by 48%.
