Merck Secures FDA Approval for Lipfendra, Aims to Diversify Revenue Streams

Merck & Co., Inc. (NYSE:MRK) is working to expand its revenue base beyond Keytruda, its cancer immunotherapy medication. A significant step in this direction came on July 16 when the US Food and Drug Administration approved Lipfendra, the first once-daily oral PCSK9 inhibitor.

Lipfendra, described by Merck as a 'once-daily oral PCSK9 inhibitor', is designed to lower LDL cholesterol levels in adults with hypercholesterolaemia. The medication has been shown to reduce LDL cholesterol levels by 56% compared to placebo at week 24, according to the CORALreef Lipids study.

Merck's acquisition of Terns Pharmaceuticals for $53.00 per share in cash on May 5 is also expected to bring new revenue streams to the company. The main asset acquired, TERN-701, is an oral allosteric BCR::ABL1 inhibitor in phase 1/2 testing for chronic myeloid leukaemia.

Merck's second-quarter 2026 results showed a 5% increase in worldwide sales to $16.6 billion, with newer products contributing more to growth than established medicines like Keytruda. However, the company reported a GAAP loss of $0.54 per share due to acquisition charges.