NewAmsterdam Pharma and Menarini Group Receive Positive CHMP Opinion Recommending Marketing Authorization for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination)

NewAmsterdam Pharma and Menarini Group Receive Positive CHMP Opinion Recommending Marketing Authorization for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination)

Positive CHMP opinion supports potential commercialization of obicetrapib monotherapy and obicetrapib/ezetimibe fixed-dose combination in Europe

Recommendation based on positive Phase 3 BROADWAY, BROOKLYN, and TANDEM data

European Commission decision expected in 2H26

NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, along with partner Menarini Group (“Menarini”), today 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 (“FDC”)) for patients with primary hypercholesterolemia, both heterozygous familial (“HeFH”) and non-familial or mixed dyslipidemia.

The positive CHMP recommendation is supported by data from NewAmsterdam's comprehensive clinical development program evaluating obicetrapib, including the Phase 3 BROADWAY, BROOKLYN and TANDEM trials, which demonstrated statistically significant LDL-C reductions up to 40% with obicetrapib monotherapy versus placebo and approximately 50% with obicetrapib combined with ezetimibe versus placebo, with a tolerability profile comparable to placebo.

NewAmsterdam and Menarini continue to advance the clinical development of obicetrapib through multiple ongoing Phase 3 trials, including PREVAIL, a cardiovascular outcomes trial, as well as REMBRANDT and RUBENS.

The CHMP’s positive opinion will now be reviewed by the European Commission (“EC”), which is expected to adopt a final decision on marketing authorization and has authority to grant centralized marketing authorization applicable across all European Union member states, as well as Iceland, Liechtenstein and Norway.

Under the parties' licensing agreement, Menarini holds exclusive commercialization rights for obicetrapib in Europe and is responsible for regulatory interactions and commercialization activities throughout the region. NewAmsterdam is entitled to tiered double-digit percentage royalties ranging from the low double-digits t...