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RAHWAY, N.J. - Merck (NYSE:MRK), a prominent player in the pharmaceuticals industry with an impressive financial health score of "GREAT" according to InvestingPro analysis, received positive news as the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of ENFLONSIA (clesrovimab) for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.
The European Commission is expected to make a final decision on marketing authorization before the end of 2025. If approved, ENFLONSIA would be the first RSV preventive option in Europe that uses the same dose regardless of infant weight. This development could further strengthen Merck’s robust revenue stream, which reached $63.6 billion in the last twelve months with an impressive gross profit margin of 77.4%.
ENFLONSIA is a long-acting monoclonal antibody designed to provide protection through five months, which typically covers an RSV season in the Northern Hemisphere. The antibody is administered as a single dose of 105 mg/0.7 mL in a prefilled syringe.
The CHMP recommendation is based on results from two clinical trials: the Phase 2b/3 CLEVER trial, which evaluated ENFLONSIA in preterm and full-term infants, and the Phase 3 SMART trial, which compared ENFLONSIA to palivizumab in infants at increased risk for severe RSV disease.
"As one of the most pervasive seasonal respiratory infections and a leading cause of infant hospitalization globally, RSV continues to place a significant burden on families and health care systems," said Dr. Macaya Douoguih, vice president at Merck Research Laboratories, according to the press release.
RSV is a contagious virus that can lead to serious respiratory conditions such as bronchiolitis and pneumonia, with RSV season typically occurring from autumn through spring in temperate climates.
ENFLONSIA was approved in the United States and United Arab Emirates in June 2025 and is currently under review in several additional markets. The medication should not be administered to infants with a history of serious hypersensitivity reactions to any component of the product.
Merck (NYSE:MRK) reported that the most common adverse reactions in clinical trials were injection-site erythema, injection-site swelling, and rash.
In other recent news, Merck has announced several significant developments. The European Medicines Agency’s Committee for Medicinal Products for Human Use has given positive opinions for Merck’s KEYTRUDA, recommending approval for a new subcutaneous administration route. This would allow the drug to be administered under the skin in a matter of minutes, pending approval in the European Union. Additionally, Merck is taking steps to finance its $10 billion acquisition of Verona Pharma by issuing investment-grade corporate bonds, as reported by Bloomberg. Meanwhile, Berenberg has downgraded Merck’s stock rating from Buy to Hold, citing concerns over Keytruda’s patent situation despite the company’s successful pipeline developments. In clinical trials, Merck, in collaboration with Daiichi Sankyo, has dosed the first patient in a phase 3 trial for a breast cancer drug targeting hormone receptor-positive, HER2-negative patients. Furthermore, Merck is set to present new cardiovascular disease data at the European Society of Cardiology Congress 2025, focusing on atherosclerotic cardiovascular disease, pulmonary hypertension, and heart failure.
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