MRK PDUFA Date: ENFLONSIA

Name: ENFLONSIA FDA decision
Start: 2027-03-22
End: 2027-03-22

Page updated November 5, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

FDA decision (PDUFA) target Mar 22, 2027 · Merck & Co., Inc. · RSV lower respiratory tract disease in children under 2 at increased risk, through their second RSV season

Source: Merck 8-K 2026-10-29 (EX-99.1, Q3 2026 results). “FDA set PDUFA date of March 22, 2027.”

Key facts

FDA PDUFA target date2027-03-22

Drug / candidateENFLONSIA (clesrovimab)

IndicationRSV lower respiratory tract disease in children under 2 at increased risk, through their second RSV season

CompanyMerck & Co., Inc.

Market-cap tierLarge

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FAQ

When is the MRK PDUFA date?

The FDA PDUFA target date for MRK (Merck & Co., Inc.) is 2027-03-22 for ENFLONSIA (clesrovimab). Dates are company/FDA-sourced and can slip. Verify against primary filings.

What is MRK's drug ENFLONSIA?

ENFLONSIA (clesrovimab) is Merck & Co., Inc.'s candidate under FDA review for RSV lower respiratory tract disease in children under 2 at increased risk, through their second RSV season.