TLDR
- The FDA approved Merck’s Lipfendra (enlicitide), the first once-daily oral PCSK9 inhibitor for high LDL-C
- Lipfendra cut LDL-C levels by 60% in two clinical trials, with no serious side effects reported
- Merck’s list price is $315/month, undercutting injectable rivals priced above $500/month
- Analysts project Lipfendra sales could exceed $350 million in 2027 and potentially $5 billion annually long-term
- Guggenheim reiterated a Buy rating and $145 price target on MRK following positive Keytruda partner trial data
Merck stock was up around 1% in premarket trading Thursday to $125, after the FDA approved Lipfendra — the first oral PCSK9 inhibitor — ahead of schedule under the agency’s expedited review program. The stock is up roughly 18% so far in 2026.
The approval is a milestone for Merck. Lipfendra, the brand name for enlicitide, is the first pill to inhibit PCSK9, a protein that controls LDL-C — commonly called “bad cholesterol.” Until now, PCSK9 inhibitors have only been available as injectables.
Today, we’re proud to announce the U.S. FDA approved the first oral PCSK9 inhibitor, providing a new treatment option as an adjunct to diet and exercise for adults living with #hypercholesterolemia, or high LDL cholesterol (LDL-C). Learn more about our approval here:… pic.twitter.com/y3EEquORbU
— Merck (@Merck) July 16, 2026
Cardiovascular disease is the leading cause of death globally and accounts for about a quarter of all U.S. deaths. Statins have been the go-to treatment since the 1980s, but they fall short for many patients, particularly those with inherited high cholesterol.
In two clinical trials, Lipfendra cut LDL-C levels by 60%. No serious side effects emerged, though around 7% of patients reported diarrhea. A longer study tracking heart attack and stroke outcomes is ongoing but won’t wrap up until 2029.
A Crowded Market, But a Price Edge
Merck is entering a market already served by injectable PCSK9 drugs. Amgen’s Repatha posted $900 million in Q1 2026 sales, up 34% year-over-year. Novartis’s Leqvio brought in $400 million in the same period, a 76% jump. Regeneron’s Praluent generated $260 million in 2025 U.S. sales.
Lipfendra’s list price of $315 per month stacks up well against injectables priced above $500. Merck says it will begin selling the pill within weeks.
Analysts project Lipfendra sales could top $350 million next year, with longer-term potential reaching $5 billion annually if uptake matches expectations.
The drug also carries strategic weight. Merck’s blockbuster cancer drug Keytruda — which generated $32 billion in annual revenue — loses patent protection in 2028. Lipfendra is one of the products Merck is counting on to offset that revenue gap.
Keytruda Pipeline Gets a Boost Too
Separately, Guggenheim reiterated its Buy rating and $145 price target on MRK on Thursday, citing positive Phase 3 data from partner Kelun-Biotech. The trial combined Kelun’s TROP2-directed ADC sacituzumab tirumotecan with Keytruda in first-line NSCLC patients with PD-L1 negative non-squamous tumors.
The combination showed a meaningful improvement in progression-free survival and a positive overall survival trend versus the control arm. Detailed data is expected at the ESMO meeting in October.
BMO Capital has a $142 price target on MRK. Scotiabank sits higher at $155, citing an expanded multiple in its cash flow analysis. MRK is currently trading near its 52-week high of $130.29.
AstraZeneca is also developing a competing oral PCSK9 inhibitor called laroprovstat, so Lipfendra’s first-mover advantage may have a limited window.
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