NewAmsterdam Pharma Co N.V. NAMS
NewAmsterdam Pharma Co N.V. (Nasdaq: NAMS) is a cardio-renal-metabolic drug developer. Its lead program, obicetrapib, is in Phase 3 for hypercholesterolemia / elevated LDL-C in patients with ASCVD and/or HeFH. Its next catalyst on record is obicetrapib + ezetimibe FDC: Launch in Germany by Menarini (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: obicetrapib + ezetimibe FDC — Launch in Germany by Menarini (Q4 2026). 7 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| obicetrapib + ezetimibe FDC | hypercholesterolemia (ASCVD/HeFH) | small molecule | Approved |
| obicetrapib monotherapy | hypercholesterolemia (ASCVD/HeFH) | small molecule | Phase 3 |
| obicetrapib (PREVAIL CVOT) | cardiovascular outcomes in ASCVD | small molecule | Phase 3 |
| obicetrapib + ezetimibe FDC (REMBRANDT) | coronary plaque reduction in high-risk ASCVD | small molecule | Phase 3 |
| obicetrapib ± ezetimibe (RUBENS) | LDL-C lowering in type 2 diabetes / metabolic syndrome | small molecule | Phase 3 |
| obicetrapib (SPINOZA) | pre-clinical Alzheimer's disease | small molecule | Phase 2 |
Recent results and decisions
- Sep 29, 2026started First participant dosed in Phase 2b SPINOZA trial (~400 participants, primary endpoint change in plasma p-tau217 at week 52)
today announced the dosing of the first participant in SPINOZA, a Phase 2b clinical trial evaluating obicetrapib in individuals with preclinical Alzheimer's disease.
Filing - approval European Commission granted marketing authorization for Ubeslo and Evlarco, marking the first regulatory approval of obicetrapib worldwide.
In September 2026, NewAmsterdam and its partner Menarini announced that the European Commission granted marketing authorization for Ubeslo® (obicetrapib 10 mg monotherapy) and Evlarco® (10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination) for patients with primary hypercholesterolaemia.
Filing - started NewAmsterdam dosed the first participant in SPINOZA Phase 2b trial evaluating obicetrapib in preclinical Alzheimer's disease.
In September 2026, NewAmsterdam announced the dosing of the first participant in SPINOZA, a Phase 2b clinical trial evaluating obicetrapib in individuals with preclinical Alzheimer's disease.
Filing
2 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 cardio-renal-metabolic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.