EMA validates MAA for NewAmsterdam's obicetrapib monotherapy and FDC with ezetimibe

NewAmsterdam Pharma Co N.V.

EMA will review Phase 3 BROADWAY, BROOKLYN and TANDEM trials supporting obicetrapib 10 mg and obicetrapib/ezetimibe FDC.
NewAmsterdam eligible for up to €863M in milestones and tiered double-digit to mid-twenties % royalties on Menarini territory net sales.
Obicetrapib monotherapy showed 33-36% LDL-C reduction vs placebo; FDC showed ~50% reduction in TANDEM trial.
MAA submitted by partner Menarini under exclusive license agreement signed June 2022.

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