Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) announced a positive opinion from the European Medicines Agency's CHMP, recommending KEYTRUDA for adults with locally advanced, early-stage triple-negative breast cancer (TNBC) at high risk of recurrence. This recommendation stems from the pivotal KEYNOTE-522 trial, which demonstrated a 37% reduction in event risk with the KEYTRUDA regimen compared to chemotherapy-placebo. The European Commission will review this recommendation, with a decision expected in Q2 2022. If approved, this will be KEYTRUDA's second indication for TNBC in Europe.

Organon (NYSE: OGN) will release its Q1 2022 financial results on May 5, 2022, before an 8:30 a.m. EDT conference call. The call will be accessible via webcast on the company's website, with a replay available approximately two hours later. Analysts and investors must register in advance using conference ID# 6895016. Formed as a spin-off from Merck (NYSE: MRK), Organon focuses on women's health, boasting a diverse portfolio of over 60 medicines. The company aims to collaborate with biopharmaceutical innovators while maintaining strong cash flows for future growth.

Merck (NYSE: MRK) announced Joseph Romanelli will lead its Human Health International division, effective August 1, 2022. Reporting to CEO Robert M. Davis, Romanelli will oversee Merck's $22 billion international business and a team of 14,000 across 75 markets. He returns to Merck after serving as CEO of JiXing Pharmaceuticals, where he led the company's growth in China, Merck's second-largest market. Romanelli's extensive experience in strategic roles since joining Merck in 1996 positions him well to drive growth in the international sector.

Merck (MRK) announced that its investigational pneumococcal vaccine, V116, has received Breakthrough Therapy Designation from the FDA for preventing invasive pneumococcal disease in adults. This vaccine targets serotypes responsible for 85% of all cases in individuals aged 65 and over in the U.S. as of 2019. Phase 3 clinical trials are set to begin in 2022, following promising results from previous studies. The breakthrough designation aims to expedite development and review, suggesting significant potential for improved outcomes compared to existing vaccines.

Merck (NYSE: MRK) will hold its first-quarter 2022 sales and earnings conference call on April 28 at 8:00 a.m. EDT. Executives will provide insights into the company's quarterly performance and future outlook. The event will be accessible to investors, journalists, and the public via a live audio webcast, with a replay and additional financial disclosures available later on their website.

Merck has a long-standing commitment to developing medicines and vaccines for serious diseases, emphasizing its role as a leading biopharmaceutical company.

Merck (NYSE: MRK) announced a significant expansion of its cardiopulmonary pipeline and portfolio, tripling its size through clinical trial advancements and business development deals in the past year. The company anticipates eight potential approvals in its cardiovascular portfolio by 2030, with initial launches expected between 2024 and 2028. The overall peak commercial revenue opportunity for this portfolio is projected to exceed $10 billion by the mid-2030s.

Merck (NYSE: MRK) has reaffirmed its commitment to enhance access to HPV vaccines by significantly investing in manufacturing. The company expanded its Elkton, VA facility by 120,000 square feet, creating 150 jobs, to meet the rising global demand for HPV vaccines. Merck aims to provide 91.5 million doses to Gavi-supported countries from 2021-2025. Having committed over $1 billion for capacity expansion, Merck expects its supply to double between 2020 and 2023 as new facilities come online.

Merck (NYSE: MRK) announced an extension of the Prescription Drug User Fee Act (PDUFA) date for their Pneumococcal 15-valent Conjugate Vaccine, VAXNEUVANCE, to July 1, 2022. The FDA requested additional analyses of data from pediatric studies, which Merck has provided. The vaccine is aimed at infants and children aged 6 weeks to 17 years for preventing invasive pneumococcal disease. Previously, VAXNEUVANCE received Priority Review from the FDA, and the company remains confident in the strength of its pediatric data.

Merck (NYSE: MRK) and Ridgeback Biotherapeutics presented data on LAGEVRIO (molnupiravir) at the 2022 European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). The Phase 3 MOVe-OUT trial results showed that LAGEVRIO led to the rapid elimination of infectious SARS-CoV-2 in patients with initial viral infection. At Days 3, 5, and 10, 0.0% of patients on LAGEVRIO had detectable infectious virus compared to 21.8% and 2.2% in the placebo group. These findings suggest LAGEVRIO's potential in treating mild to moderate COVID-19 among at-risk adults.