FDA Approves Merck's LIPFENDRA, First Oral PCSK9 Inhibitor for High Cholesterol
MRK sits 62% above its 52-week low of $76.66.
Summary
The FDA approved Merck's LIPFENDRA (enlicitide), the first once-daily oral PCSK9 inhibitor, for adults with hypercholesterolemia. In Phase 3 trials, it reduced LDL-C by 56-59% versus placebo, with a safety profile similar to placebo. This opens a large primary care market previously dominated by injectable PCSK9s like Repatha and Praluent. An ongoing outcomes trial will determine if it reduces cardiovascular events, a key catalyst for broad adoption. The approval adds a significant growth driver to Merck's portfolio, complementing recent Keytruda expansions and pipeline successes like Tulisokibart.
At the time of this announcement, MRK was trading at $124.10 on NYSE in the Life Sciences sector, with a market capitalization of approximately $305.3B. The 52-week trading range was $76.66 to $130.29. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: BusinessWire.