NewAmsterdam Pharma Co N.V 8-K, filed Sep 21, 2026
NewAmsterdam Pharma Co N.V. (NAMS)
About this 8-K
NewAmsterdam Pharma Co N.V filed this 8-K on September 21, 2026.
NewAmsterdam Pharma Company N.V. received European Commission marketing authorization for Ubeslo® and Evlarco®, the first worldwide obicetrapib approval. It will receive tiered double-digit royalties and up to €833 million in milestones. AI summary
Items reported
- Item 8.01: Other events
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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Item 8.01 |
Other Events. |
On September 21, 2026, NewAmsterdam Pharma Company N.V. (the “Company”) along with its partner Menarini Group (“Menarini”) announced that the European Commission (“EC”) has granted marketing authorization for Ubeslo® (obicetrapib 10 mg monotherapy) and Evlarco® (10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination, or “FDC”) for patients with primary hypercholesterolaemia (heterozygous familial (“HeFH”) and non-familial) or mixed dyslipidaemia, marking the first regulatory approval of obicetrapib worldwide. The authorizations apply across all EU Member States, as well as Iceland, Liechtenstein and Norway. The authorizations require customary post-approval safety monitoring, pharmacovigilance activities, and risk-minimization measures, as well as, among other things, a post-authorization efficacy study, for which the EC has specified that the Company must submit the final results from the Company’s PREVAIL cardiovascular outcomes trial, a placebo-controlled, double-blind, randomized trial evaluating obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to potentially enhance low-density lipoprotein cholesterol lowering in patients with atherosclerotic cardiovascular disease and/or HeFH.
The Company and Menarini are party to a licensing agreement pursuant to which Menarini holds exclusive commercialization rights for obicetrapib in Europe and is responsible for regulatory interactions and commercialization activities throughout the region. The Company is entitled to tiered double-digit percentage royalties ranging from the low double-digits to mid-twenties on net sales in the Menarini Territory (as defined in the Menarini licensing agreement) and up to an additional €833 million upon the achievement of various clinical, regulatory and commercial milestones, of which milestone payments in the mid-teens of millions of euros are triggered by the EC’s marketing authorizations for obicetrapib and the FDC.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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NewAmsterdam Pharma Company N.V. |
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Date: |
September 21, 2026 |
By: |
/s/ Mike Marino |
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Name: |
Mike Marino |
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Title: |
Chief Legal Officer |