ApprovalJul 16, 2026103 days ago
FDA approves LIPFENDRA (enlicitide), first once-daily oral PCSK9 inhibitor
The FDA approved Merck &’s LIPFENDRA (enlicitide) for Hypercholesterolemia including HeFH on Jul 16, 2026. The company can now sell it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
DetailsRegulatory approval
- Company
- Merck & Co., Inc. MRK
- Drug
- LIPFENDRA (enlicitide)
- For
- Hypercholesterolemia including HeFH
- Stage
- Regulatory (NDA)
- When
- Jul 16, 2026
- Source note
- Approved as an adjunct to diet and exercise to lower LDL-C in adults with hypercholesterolemia including HeFH. CORALreef Lipids and CORALreef HeFH showed placebo-adjusted LDL-C reductions of 56% and 59% at week 24.
- Checked
- Checked by a person when it was added
Check the sourcesdon’t take our word for it
- Source: finance.yahoo.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- MRK headlines on this site
Merck & Co., Inc.
1 upcoming · 13 past catalysts
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- Entry
- Sac-TMT TroFuse-005 endometrial cancer detailed Ph3 data presentation · Clinical trial results (readout / topline data)
- Drug
- sacituzumab tirumotecan (MK-2870)
- For
- Advanced/recurrent endometrial cancer (TroFuse-005)
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Merck Aug 4, 2026 Q2 earnings slides list this under milestones 'expected over next six months' (Aug 2026-Jan 2027); no congress named, so H2 2026 is an approximation of that window. Topline (OS and PFS met) was announced in Q2 2026.
- Checked
- Checked by a person when it was added
- Verify it
- Source: merck.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- MRK headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page