NewAmsterdam Pharma Company N.V.: NewAmsterdam Pharma and Menarini Group Receive Positive CHMP Opinion Recommending Marketing Authorization for Ubeslo (Obicetrapib Monotherapy) and Evlarco (Obicetrapi
NewAmsterdam Pharma (Nasdaq: NAMS) and Menarini said the EMA CHMP issued a positive opinion recommending marketing authorization in Europe for Ubeslo (obicetrapib 10 mg) and Evlarco (obicetrapib 10 mg plus ezetimibe 10 mg) for primary hypercholesterolemia. The recommendation is based on Phase 3 BROADWAY, BROOKLYN, and TANDEM results showing LDL-C reductions up to 40% and about 50%. European Commission decision expected in 2H26.
How this was made
The 30-second read
Why it matters
The CHMP positive opinion recommends marketing authorization for Ubeslo (obicetrapib monotherapy) and Evlarco (obicetrapib plus ezetimibe FDC) for primary hypercholesterolemia in HeFH and non-familial or mixed dyslipidemia, advancing the EU regulatory pathway to a European Commission decision expected in 2H26.
Market read
This is a concrete regulatory de-risking event for NAMS’s lead asset in Europe, with a defined next decision gate (European Commission) later in 2026.
What to watch
Royalty economics depend on Menarini’s commercialization execution and uptake; the article does not quantify expected EU launch timing, pricing, or competitive positioning versus existing LDL-C therapies.
Background
NewAmsterdam is a late-stage biopharma developing obicetrapib, an oral CETP inhibitor, with Menarini holding exclusive European commercialization rights under a licensing agreement.
Ticker impact
NewAmsterdam received a positive CHMP opinion recommending marketing authorization for Ubeslo and Evlarco in Europe, moving the regulatory process forward.
Likely positive near-term sentiment for NAMS into the European Commission decision window, though magnitude depends on market expectations for obicetrapib’s approval odds.
The article discloses a fresh regulatory milestone (CHMP positive opinion) and specifies the products and expected EC decision timing in 2H26, but it does not provide new efficacy/safety data beyond previously referenced Phase 3 results.
Market effects
Supports the broader CETP inhibitor and non-statin LDL-C lowering pipeline narrative, potentially improving perceived probability of success for similar late-stage programs.
Improves prospects for EU access to obicetrapib-based therapies, which can shift competitive dynamics in European lipid management.
EU approval progress can strengthen global commercialization credibility and partner confidence, even though the decision is specifically for centralized EU authorization.
Counterpoint
A CHMP positive opinion is not final approval; the European Commission could still delay or modify the decision, so the market may already price in regulatory momentum.
Key entities
- companyNewAmsterdam Pharma Company N.V.
Nasdaq-listed late-stage biopharmaceutical developing obicetrapib; subject of the CHMP regulatory milestone.
- companyMenarini Group
Partner with exclusive commercialization rights for obicetrapib in Europe and responsible for regulatory interactions and commercialization activities.
- regulatorEuropean Medicines Agency (EMA) CHMP
Committee for Medicinal Products for Human Use that adopted the positive opinion recommending marketing authorization.
- regulatorEuropean Commission
Expected to adopt the final centralized marketing authorization decision in 2H26.
