RegulatoryCompany release

NewAmsterdam posts Q3 results after first EU approvals of obicetrapib products Ubeslo and Evlarco

🇺🇸 NewAmsterdam Pharma Co N.V. (NAMS) · Wed 04 Nov 2026

The European Commission cleared the two obicetrapib medicines in September, the first approvals worldwide, with partner Menarini planning a German launch by the end of 2026.

NewAmsterdam Pharma reported third-quarter 2026 results on 4 November, following European Commission approval in September of Ubeslo (obicetrapib monotherapy) and Evlarco (obicetrapib with ezetimibe). The company says these are the first approvals of obicetrapib anywhere in the world.

Both products are authorised for primary hypercholesterolaemia and mixed dyslipidaemia. Partner Menarini plans to launch them in Germany by the end of 2026 and in the UK in 2027.

On the financial side, NewAmsterdam reported $643.1 million in cash and quarterly revenue of $19.2 million. The company attributed the revenue to regulatory milestones payable by Menarini.

The update also covered the pipeline. NewAmsterdam has begun SPINOZA, a Phase 2b trial in preclinical Alzheimer's disease, and it expects an interim analysis from the PREVAIL study in the fourth quarter of 2026.

What it means for your team

  • Market-access teams in Germany and the UK should note Menarini's stated launch timelines (Germany by end-2026, UK in 2027), as pricing and reimbursement steps will follow.
  • The EU authorisation covers both a monotherapy and a fixed-dose combination with ezetimibe, which may matter for lipid-lowering treatment pathway planning.
  • The PREVAIL interim analysis expected in Q4 2026 is a near-term data event for those tracking the product's evidence base.
  • Revenue to date reflects Menarini regulatory milestones, not product sales, so commercial uptake remains to be seen.

Company's press release (SEC filing): NewAmsterdam Pharma Co N.V. ↗

Article written by VigiEye from the official source (NewAmsterdam Pharma Co N.V.). Claims are the company's own. AI-assisted; check the source before acting.

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