MRK FDA decision — Jul 16, 2026
✓ APPROVED
Lipfendra (enlicitide decanoate) approved — the first oral PCSK9 inhibitor to lower LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH) (Jul 16 2026).
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Key facts
FDA decision date2026-07-16
OutcomeApproved
Drug / candidateLipfendra (enlicitide decanoate, MK-0616)
ClassOral PCSK9 inhibitor (macrocyclic peptide) — first-in-class
IndicationHypercholesterolemia incl. HeFH — LDL-C lowering, adjunct to diet/exercise
CompanyMerck & Co. (Merck Sharp & Dohme LLC)
PivotalCORALreef Lipids (NCT05952856)
Market-cap tierLarge
Cohort decision-day move (history)±1% median
Cohort move is the historical median absolute decision-day move for this market-cap tier — history, not a prediction.
Primary source: FDA — "FDA Approves First Oral PCSK9 Inhibitor" (Jul 17 2026). Company release: Merck.
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