Lipfendra (enlicitide decanoate) was approved by the FDA on July 15, 2026 for hypercholesterolemia incl. HeFH (LDL-C lowering), the 26th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
Lipfendra (enlicitide decanoate) approved, the first oral PCSK9 inhibitor to lower LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH) (Jul 16 2026).
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Primary source: FDA, "FDA Approves First Oral PCSK9 Inhibitor" (Jul 17 2026). Company release: Merck.
FDA record of the action: the FDA approved on July 15, 2026, per NDA 220848 ORIG-1 (FDA letter). The sponsor announced it on July 16, 2026. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| OrbiMed Advisors | 663,400 | $85.2 million | filed August 14, 2026 |
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Yes. The FDA approved the application for Lipfendra (enlicitide decanoate, MK-0616) on July 15, 2026, per the FDA's own record. The company announced it on July 16, 2026. The primary source is linked on this page.
Lipfendra (enlicitide decanoate, MK-0616) is a Merck & Co. (Merck Sharp & Dohme LLC) (MRK) program. The FDA decision came on July 15, 2026; the FDA's own record of the decision is linked on this page.