NAMS | Market Cap: $3.9B (07/13/26)
Industry:
Pharma & Biotech

DESCRIPTION

NewAmsterdam Pharma is a pre-revenue, late-stage biopharmaceutical company built around a single asset: obicetrapib, an oral, once-daily CETP inhibitor designed to lower LDL cholesterol in high-risk cardiovascular patients. The company targets the large population of patients who cannot reach LDL-C goals on statins alone but prefer not to use injectable therapies like PCSK9 inhibitors. Obicetrapib works by blocking CETP, a protein that transfers cholesterol into LDL particles, which lowers LDL-C and accelerates its clearance from the bloodstream. Three Phase 3 trials have met their primary endpoints, with obicetrapib reducing LDL-C by roughly 33–36% as monotherapy and ~52% in a fixed-dose combination with ezetimibe. Obicetrapib also reduces Lp(a), an independent cardiovascular risk factor that statins and most other LDL-lowering drugs do not address. An ongoing Phase 3 cardiovascular outcomes trial (PREVAIL) with 9,500+ patients is expected to conclude no earlier than late 2026. NewAmsterdam plans to file an NDA with the FDA and has licensed European commercialization rights to Menarini, which submitted regulatory applications in 2025. In the U.S., NewAmsterdam intends to commercialize obicetrapib directly. The company is also exploring obicetrapib in Alzheimer's disease, based on early data suggesting CETP inhibition may slow Alzheimer's pathology, with a dedicated Phase 2 trial planned for 2026.

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