NewAmsterdam Pharma Co N.V. 8K

NewAmsterdam Pharma and Menarini received a positive CHMP opinion recommending EU marketing authorization for Ubeslo and Evlarco, obicetrapib-based cholesterol-lowering therapies, with an EC decision expected in 2H 2026.

NewAmsterdam Pharma Company N.V. and its European commercialization partner Menarini Group announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization in Europe for Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (a fixed-dose combination of 10 mg obicetrapib plus 10 mg ezetimibe) to treat patients with primary hypercholesterolemia, both heterozygous familial and non-familial or mixed dyslipidemia, based on positive Phase 3 BROADWAY, BROOKLYN, and TANDEM trial data showing substantial LDL-C reductions and placebo-like tolerability, with a final European Commission decision expected in the second half of 2026 that, if favorable, would trigger Menarini’s exclusive commercialization across Europe and related tiered double-digit royalties and up to €833 million in potential milestone payments for NewAmsterdam.

Filing Facts

CIK

1936258

Ticker

NAMS

Form

8K

Source Type

fda

Accession

0001193125-26-315163

Alert Tier

6