Merck & Co Stock Price, News & Analysis

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.

Eikon Therapeutics has appointed Kenneth C. Frazier as its first independent director, effective April 1, 2022. Frazier, the former CEO of Merck (NYSE:MRK) and current director at Exxon Mobil Corporation (NYSE:XOM), brings extensive pharmaceutical industry expertise. His leadership at Merck was marked by the advancement of numerous significant medicines. Eikon's CEO, Roger M. Perlmutter, expressed that Frazier's knowledge and advocacy for social justice will greatly benefit the company's mission in drug discovery and development.

Organon (NYSE: OGN) and Daré Bioscience (NASDAQ: DARE) have entered an agreement for Organon to license global rights to XACIATO, an FDA-approved treatment for bacterial vaginosis (BV) affecting an estimated 21 million U.S. women. The deal includes a $10 million upfront payment to Daré, potential milestone payments of up to $182.5 million, and tiered royalties on net sales. XACIATO is expected to be commercially available in the U.S. in Q4 2022, pending regulatory review. This collaboration aligns with Organon's strategy to enhance women's healthcare options.

Merck (NYSE: MRK) announced that the European Medicines Agency’s CHMP has recommended approval of KEYTRUDA for treating certain cancers with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors. This includes patients with unresectable or metastatic colorectal, gastric, small intestine, and biliary cancers, as well as advanced or recurrent endometrial carcinoma after previous therapies. The recommendation is based on successful results from the Phase 2 KEYNOTE-158 and KEYNOTE-164 trials, supporting its use as a monotherapy.

Merck (NYSE: MRK) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of KEYTRUDA combined with chemotherapy for treating persistent, recurrent, or metastatic cervical cancer in adults with PD-L1 expressing tumors (CPS ≥1). This recommendation follows the Phase 3 KEYNOTE-826 trial, which showed significant improvements in overall survival (HR=0.64) and progression-free survival (HR=0.62), with a 68% objective response rate compared to 50% for chemotherapy alone. A final decision from the European Commission is anticipated in Q2 2022.

Merck (NYSE: MRK) announced the retirement of Dr. Roy D. Baynes, Chief Medical Officer, effective July, with Dr. Eliav Barr succeeding him on April 1, 2022. Dr. Baynes has significantly contributed to Merck's oncology leadership, notably through the development of KEYTRUDA. Under Dr. Barr, who has over two decades with Merck, the company aims to continue advancements in clinical development, particularly in oncology and vaccines. This leadership transition aims to ensure ongoing growth and innovation in Merck’s pipeline.

Merck (NYSE: MRK) presented findings at the 48th Annual European Society for Blood and Marrow Transplantation Meeting, revealing that PREVYMIS™ (letermovir) significantly lowers the risk of cytomegalovirus (CMV) reactivation in CMV-seropositive patients undergoing allogeneic hematopoietic cell transplantation. The meta-analysis of 48 studies showed a 87% reduction in CMV reactivation and a 91% reduction in clinically significant CMV infections at 100 days. Results were consistent at 200 days, reinforcing PREVYMIS as a critical prophylactic treatment in this high-risk patient population.