Enflonsia (clesrovimab)
Launched for RSV prevention in infants; sBLA for children under two in their second RSV season has a March 22, 2027 FDA target date.
What it is
Monoclonal antibody that prevents RSV lower respiratory tract disease in infants in their first RSV season. Merck filed to extend it to high-risk children under two in their second season, supported by the Phase 3 SMART trial.
Why it matters to the stock. The second-season label would widen its eligible population.
News
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