NewAmsterdam wins EU approval for obicetrapib, first regulatory approval worldwide
The European Commission granted marketing authorization for Ubeslo and Evlarco, obicetrapib-based treatments for primary hypercholesterolaemia or mixed dyslipidaemia, marking the first regulatory approval of obicetrapib worldwide. The company's partner Menarini holds European commercialization rights, and the approvals trigger milestone payments in the mid-teens of millions of euros, with up to an additional €833 million available on future milestones.
Key points
- Approvals cover all EU Member States, Iceland, Liechtenstein and Norway
- Ubeslo is obicetrapib 10 mg monotherapy; Evlarco is 10 mg obicetrapib plus 10 mg ezetimibe
- EC requires a post-authorization efficacy study and final results from the PREVAIL cardiovascular outcomes trial
- Menarini milestone payments in the mid-teens of millions of euros triggered by the authorizations
The filing
Written by AI on Nov 9, 2026, 11:45 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 21, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.