Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) has reached an agreement with the U.S. Government to develop and manufacture MK-7110, an investigational therapy for COVID-19, pending FDA approval. The deal is valued at approximately $356 million, aiming to supply 60,000-100,000 doses by June 30, 2021, as part of Operation Warp Speed. MK-7110 has shown promising results, with a 60% higher probability of clinical improvement in COVID-19 patients compared to placebo. The ongoing Phase 3 trial enrolled 243 patients, indicating robust efficacy for severe COVID-19 cases.

Merck (NYSE: MRK) announced that the FDA has accepted and granted priority review for a new sBLA for KEYTRUDA, used with chemotherapy for first-line treatment of locally advanced unresectable or metastatic esophageal and gastroesophageal junction carcinoma. This decision is based on pivotal Phase 3 KEYNOTE-590 trial data, which showed significant improvements in overall survival and progression-free survival compared to chemotherapy alone. The PDUFA target action date is April 13, 2021. Currently, KEYTRUDA is approved for second-line treatment in the U.S., China, and Japan.

Merck (NYSE: MRK) and Eisai announced that their Phase 3 trial of KEYTRUDA® (pembrolizumab) combined with LENVIMA® (lenvatinib) for advanced endometrial cancer met its primary endpoints: overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). The trial showed significant survival advantages over chemotherapy regimens in both the mismatch repair proficient and intention-to-treat populations. The companies plan to present results at medical meetings and submit applications for marketing authorization based on the findings.

Merck (NYSE: MRK) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for KEYTRUDA, recommending its approval as a first-line treatment for adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This recommendation is based on the Phase 3 KEYNOTE-177 trial, which showed a significant improvement in progression-free survival compared to standard chemotherapy regimens. A final decision by the European Commission is anticipated in Q1 2021.

Merck (NYSE: MRK) announced that Robert M. Davis, CFO and Executive VP, will participate in a virtual fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on December 2, 2020, at 9:40 a.m. EST. Investors, analysts, and the public can listen to the live audio webcast via Merck's official site.

Merck has been dedicated to discovering medicines and vaccines for over 125 years, focusing on critical diseases including cancer and infectious diseases.

Merck (NYSE: MRK) has submitted applications for its investigational 15-valent pneumococcal conjugate vaccine, V114, to both the FDA and EMA, targeting adults 18 and older. The applications are based on Phase 2 and Phase 3 clinical study results, addressing various adult populations, including those at increased risk. V114 aims to enhance protection against pneumococcal disease with serotypes not included in existing vaccines. Notably, it has previously received Breakthrough Therapy Designation from the FDA for certain age groups.

Merck (NYSE: MRK) has entered into a definitive agreement to acquire OncoImmune for $425 million in cash, with additional sales-based and regulatory milestone payments. The acquisition is bolstered by positive interim results from OncoImmune's Phase 3 trial for CD24Fc, a treatment for severe COVID-19, showing a 60% improvement in clinical status and over a 50% reduction in the risk of death. The deal is expected to close before the end of 2020, pending regulatory approvals. Merck will also invest $50 million in a new entity formed from OncoImmune's non-CD24Fc assets.

Merck (NYSE: MRK) has declared a quarterly dividend of $0.65 per share for Q1 2021. The payment date is set for January 8, 2021, with shareholders on record by December 15, 2020. This decision underscores Merck's commitment to returning income to shareholders while continuing its mission of advancing healthcare through innovative medicines and vaccines.

Merck has been a leader in the biopharmaceutical industry for over 125 years, focusing on significant health challenges including cancer and infectious diseases.