NewAmsterdam Pharma gets positive CHMP opinion for obicetrapib-based Ubeslo and Evlarco, EC decision due 2H26

NewAmsterdam Pharma received a positive CHMP opinion recommending EU marketing authorization for Ubeslo and Evlarco.Key Highlights:Original SEC Filing: NewAmsterdam Pharma Co N.V. [ NAMS ] - 8-K - Jul. 24, 2026This is an AI-powered summary. It may contain inaccuracies. Consider verifying important…

NewAmsterdam Pharma received a positive CHMP opinion recommending EU marketing authorization for Ubeslo and Evlarco.

Key Highlights:

CHMP recommended marketing authorization for Ubeslo (obicetrapib 10 mg) and Evlarco (obicetrapib 10 mg + ezetimibe 10 mg FDC).
Recommendation based on Phase 3 BROADWAY, BROOKLYN and TANDEM data showing LDL-C reductions up to ~40% (monotherapy) and ~50% (with ezetimibe).
European Commission final decision on centralized marketing authorization expected in 2H26, applicable across EU, Iceland, Liechtenstein and Norway.
Menarini holds exclusive commercialization rights in Europe; NewAmsterdam entitled to tiered double-digit royalties and up to €833M in milestones.

Original SEC Filing:

This is an AI-powered summary. It may contain inaccuracies. Consider verifying important information with the source. Please note this summary is solely based on documents filed with the SEC.