NAMS biotech catalysts & pipeline

NEWAMSTERDAM PHARMA CO NV · Data as of 2026-09-08

Upcoming catalysts

obicetrapib — Initial data

during 2026

Following the successful completion and positive topline results of the Phase 3 BROADWAY, TANDEM, and BROOKLYN trials, NewAmsterdam plans to announce additional clinical data from these trials relating to obicetrapib and the fixed-dose combination ("FDC") of obicetrapib plus ezetimibe during 2026.

Source filing

obicetrapib — Regulatory decision

H2 2026

We anticipate that Menarini will receive decisions on the MAAs from each of the regulators in the second half of 2026.

Source filing

obicetrapib and obicetrapib/ezetimibe — Regulatory decision

2H26

– Decisions on regulatory approval from EMA, UK, and Switzerland for obicetrapib and obicetrapib/ezetimibe fixed ‑ dose combination expected in 2H26, and based on the outcomes, with potential launches by Menarini in 4Q26 in Germany and the UK –

Source filing

Ubeslo® (obicetrapib monotherapy) and Evlarco® (obicetrapib plus ezetimibe fixed-dose combination) — Regulatory decision

2H26

European Commission decision expected in 2H26

Source filing

obicetrapib — Topline data

Late 2026

The trial is expected to enroll approximately 300 patients, with topline data expected by year end 2026.

Source filing

obicetrapib — Interim data

1Q2027

– PREVAIL interim analysis planned for 4Q2026 with result expected in 1Q2027 –

Source filing

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