Merck reported pivotal Phase 3 data showing its oral PCSK9 inhibitor, enlicitide, produced LDL-C reductions comparable to injectable PCSK9 inhibitors. The company presented re‑analysed results at the American Heart Association meeting showing about a 59.7% reduction in LDL-C versus placebo in high‑risk patients on background lipid therapy. The readout came from the CORALreef program, including a large trial of ~2,900 patients. Analysts at Leerink Partners flagged the oral route, room‑temperature stability and potential pricing as differentiators that could drive primary‑care uptake if the drug secures FDA approval. The re‑analysis corrected data handling issues and reaffirmed the trial met its primary endpoint. Enlicitide’s performance in a familial hypercholesterolemia cohort echoed the broader results. If approved, an oral PCSK9 could shift prescribing away from current injectable biologics by addressing route-of-administration barriers in primary care and reducing cold‑chain constraints. Regulators and payers will scrutinize long‑term outcomes and safety, but the Phase 3 efficacy signal positions Merck to challenge incumbents in the lipid‑lowering market.