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Merck (MRK) Gets FDA Approval for LIPFENDRA, First Oral PCSK9 Inhibitor

Merck (MRK) received FDA approval for LIPFENDRA, the first oral PCSK9 inhibitor for lowering LDL cholesterol. The stock trades at $127.47 with a one-year total shareholder return of 56.86%.

July 23, 2026
2 min read
Source: Simply Wall St.
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Key Numbers

share price
$127.47
30 day return
10.38%
ytd return
19.75%
1 year tsr
56.86%

Merck (MRK) announced FDA approval of LIPFENDRA, the first oral PCSK9 inhibitor for reducing LDL cholesterol. This marks a significant addition to Merck's cardiovascular portfolio. The stock has gained 10.38% over the past 30 days and 19.75% year-to-date, with a one-year total shareholder return of 56.86%.

The Product

LIPFENDRA is the first oral medication in the PCSK9 inhibitor class, which previously required injections. It works by inhibiting the PCSK9 protein, increasing the liver's ability to remove LDL cholesterol from the blood. This offers a more convenient option for patients with hypercholesterolemia.

Pricing and Availability

Merck has not yet disclosed the price or launch date for LIPFENDRA. It is expected to compete with injectable PCSK9 inhibitors like Repatha (Amgen) and Praluent (Sanofi/Regeneron).

Competition

LIPFENDRA enters a market dominated by injectable PCSK9 inhibitors, but its oral formulation could provide a significant advantage. It also competes with statins, which remain first-line therapy.

Potential Impact on Merck

LIPFENDRA could diversify Merck's revenue beyond its blockbuster drug Keytruda and strengthen its cardiovascular pipeline. Commercial success will depend on pricing, insurance coverage, and physician adoption.

Frequently Asked Questions

LIPFENDRA is the first oral PCSK9 inhibitor approved by the FDA to lower LDL cholesterol.

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This article was rewritten in Wrqti's editorial style based on information from the original source above. Content is informational only — not investment advice.