NewAmsterdam Pharma Obicetrapib Receives Positive CHMP Opinion

Naarden, the Netherlands, Miami, USA, and Florence, Italy - NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) and its partner, the Menarini Group, have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination). The recommendation targets patients suffering from primary hypercholesterolemia, including those with heterozygous familial (HeFH) and non-familial or mixed dyslipidemia.

The CHMP positive opinion follows a comprehensive clinical development program, including the Phase 3 BROADWAY, BROOKLYN, and TANDEM trials. These studies demonstrated significant LDL-C reductions, with up to 40% reduction for obicetrapib monotherapy and approximately 50% for the combination therapy compared to placebo, while maintaining a tolerability profile comparable to the placebo group.

Key Highlights

• Positive recommendation for Ubeslo and Evlarco in the European Union.
• Expected final decision by the European Commission in the second half of 2026.
• Strategic partnership with Menarini Group for exclusive commercialization rights in Europe.
• Ongoing clinical development continues with the Phase 3 PREVAIL, REMBRANDT, and RUBENS trials.

If granted, the marketing authorization would cover all European Union member states, as well as Iceland, Liechtenstein, and Norway. NewAmsterdam Pharma is entitled to tiered royalties on net sales in the Menarini territory, in addition to potential milestone payments of up to 833 million Euro.