Oral PCSK9i approved for high cholesterol, an expected positive

Research evidence excerpt

Oral PCSK9i approved for high cholesterol, an expected positive

Update

July 16, 2026 01:32 PM GMT

Morgan Stanley & Co. LLCMMerck & Co., Inc. | North America Terence C Flynn, Ph.D.

Equity Analyst

Oral PCSK9i approved for high Terence.Flynn@morganstanley.comAlexander Yevdokimov, Ph.D. +1 212 761-2230

Research Associate

Alexander.Yevdokimov@morganstanley.com +1 212 761-2167

cholesterol, an expected Hailey Horowitz

Hailey.Horowitz@morganstanley.com +1 212 761-5264

positive Chris Yu, J.D., Ph.D.

Chris.L.Yu@morganstanley.com +1 212 761-2535

MRK announced FDA approval of Lipfendra (enlicitide), a once-daily oral PCSK9

Connor M Massari

inhibitor, as an adjunct to diet and exercise to reduce cholesterol/LDL-C in adults Equity Analyst

with hypercholesterolemia, including heterozygous familial Connor.Massari@morganstanley.com +1 212 761-2417

Damien H Kerner

hypercholesterolemia (HeFH) (LINK). The approval was largely expected following Research Associate

the positive Ph3 CORALreef Lipids and CORALreef HeFH topline data (see HERE Damien.H.Kerner@morganstanley.com +1 212 761-3829

and HERE), as well as receipt of the FDA’s CNPV (see HERE). Lipfendra is the first Morgan Stanley India Company Private Limited+

Saket AgarwalFDA-approved oral PCSK9 inhibitor and will compete with three existing injectable

options. Saket.Agarwal@morganstanley.com +91 22 6995-4012

Interestingly the label notes cardiovascular outcomes trials have demonstrated that Merck & Co., Inc. (MRK.N, MRK UN)

reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in Major Pharmaceuticals | United States of America

adults at increased risk when treated with statins or monoclonal antibody PCSK9 Stock Rating Equal-weight

inhibitors as an add-on to statin therapy. Industry View In-Line