Merck (MRK) Announces Positive Phase 3 SMART Trial Results for ENFLONSIA (Clesrovimab)

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Merck announced positive second-season findings from its Phase 3 SMART trial for ENFLONSIA (clesrovimab) in infants and children under 2 at increased risk for severe RSV. The results showed similar serum concentrations and a consistent safety profile compared to previous studies, supporting extended protection and potential for an expanded indication. ENFLONSIA was FDA-approved in June 2025 for infants in their first RSV season and provides five months of protection with a single dose.

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