Menarini Group and NewAmsterdam Pharma Receive European Commission Approval for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination)
The European Commission approved obicetrapib products from Menarini Group and NewAmsterdam Pharma, marking the drug’s first global regulatory approval. The decision creates a commercial launch setup for NewAmsterdam while putting execution against the Phase 3 efficacy and tolerability profile into focus.
The European Commission approved Ubeslo, an obicetrapib monotherapy, and Evlarco, a fixed-dose combination of obicetrapib and ezetimibe, developed by Menarini Group and NewAmsterdam Pharma. The approval is supported by the Phase 3 BROADWAY, BROOKLYN and TANDEM trials, which demonstrated significant LDL-C reductions and a favorable tolerability profile.
The decision is described as the first global regulatory approval for obicetrapib and marks a regulatory milestone for both companies. It moves the program from late-stage clinical development into the commercial phase in Europe.
For NewAmsterdam, the approval connects its obicetrapib program to potential product revenue, while Menarini becomes the larger pharmaceutical partner associated with the European rollout. NewAmsterdam reported $22.5M of revenue in FY 2025, down 50.6% year over year, before this approval.
The immediate commercial outcome remains uncertain: the approval establishes the regulatory basis for the products but does not by itself provide launch sales or market-share figures. Execution, European commercialization and the products’ uptake will determine how quickly the milestone changes NewAmsterdam’s financial profile.
The next milestones are the European launch process and subsequent company updates on commercialization, prescription demand and revenue contribution.
NAMS won EU approval for Ubeslo and Evlarco, obicetrapib’s first global regulatory clearance.
The approval gives NewAmsterdam a path from a pre-commercial program to product revenue, but the company enters that phase from FY 2025 revenue of $22.5M, down 50.6% year over year, and a -902.1% net margin. The commercial launch and the first reported uptake figures will decide whether the regulatory milestone becomes a material change in the company’s financial trajectory.
A slow European launch or limited prescribing could leave the approval disconnected from near-term revenue, while NewAmsterdam’s FY 2025 losses show the funding profile remains important.
CoverageSource: PR Newswire · Published here MON, SEP 21 · 10:57 AM ET · the only report in this recordHow this is decided →
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The first global approval, backed by three Phase 3 trials showing significant LDL-C reductions and favorable tolerability, gives NewAmsterdam a validated product to commercialize.
The approval has not yet established launch demand or revenue, and FY 2025 revenue was $22.5M with a -902.1% net margin.
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