MRK · 8-K · 20260804PR090045
Regulatory Approval Milestones
Merck & Co., Inc. · 2026-08-04 · Importance 38 · Surprise 60 · No source text
The U.S. FDA approved LIPFENDRA (enlicitide) as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia. Merck described it as the first and only once-daily oral PCSK9 inhibitor and based the approval on the Phase 3 CORALreef Lipids and CORALreef HeFH trials. At week 24, LIPFENDRA produced placebo-adjusted LDL-C reductions of 56% and 59%, respectively.
Key facts
- Merck received U.S. FDA approval for LIPFENDRA (enlicitide), the first and only once-daily oral PCSK9 inhibitor to reduce LDL-C in adults with hypercholesterolemia source
- FDA granted Breakthrough Therapy designation for calderasib (MK-1084) in combination with KEYTRUDA for first-line treatment of advanced/metastatic NSCLC with KRAS G12C mutation expressing PD-L1 TPS >=1% source
- KEYTRUDA and KEYTRUDA QLEX, each with Trodelvy, were FDA approved as first-line treatment of PD-L1 positive advanced TNBC based on Phase 3 KEYNOTE-D19/ASCENT-04 source
- In July, FDA approved expanded use of KEYTRUDA and KEYTRUDA QLEX, each with Padcev, as treatment before and after surgery for adult patients with muscle-invasive bladder cancer including cisplatin eligible patients based on Phase 3 KEYNOTE-B15 trial source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | Merck received U.S. FDA approval for LIPFENDRA (enlicitide), the first and only once-daily oral PCSK9 inhibitor to reduce LDL-C in adults… |
| revenue | positive | probable | — | FDA granted Breakthrough Therapy designation for calderasib (MK-1084) in combination with KEYTRUDA for first-line treatment of… |
| revenue | positive | committed | — | KEYTRUDA and KEYTRUDA QLEX, each with Trodelvy, were FDA approved as first-line treatment of PD-L1 positive advanced TNBC based on Phase 3… |
| revenue | positive | committed | — | In July, FDA approved expanded use of KEYTRUDA and KEYTRUDA QLEX, each with Padcev, as treatment before and after surgery for adult… |