CHMP recommends EU marketing authorization for obicetrapib cholesterol therapies

Filed July 24, 2026 · Period ending July 24, 2026 · ~1 min read

Key Changes

• high

  European Medicines Agency's CHMP issued positive opinion recommending marketing authorization for Ubeslo (obicetrapib monotherapy) and Evlarco (obicetrapib/ezetimibe combination) for hypercholesterolemia; European Commission decision expected 2H 2026.

  Item 8.01 verify on EDGAR →
• high

  CHMP recommendation based on Phase 3 data showing LDL-C reductions up to 40% with monotherapy and approximately 50% with combination therapy; approval would enable commercialization across EU member states plus Iceland, Liechtenstein, and Norway.

  Exhibit 99.1 view on EDGAR →
• high

  Under Menarini partnership, NewAmsterdam entitled to tiered royalties (low double-digits to mid-twenties on net sales) and up to €833 million in clinical, regulatory, and commercial milestone payments; Menarini holds exclusive European commercialization rights.

  Exhibit 99.1 view on EDGAR →