NewAmsterdam Pharma N.V. Announces Positive CHMP Opinion for Ubeslo, Evlarco

What Happened

• On July 24, 2026, NewAmsterdam Pharma Company N.V. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending marketing authorization for Ubeslo (obicetrapib monotherapy) and Evlarco (obicetrapib plus ezetimibe fixed‑dose combination). The announcement was made jointly with the Menarini Group and the company filed a press release as Exhibit 99.1 to its Form 8‑K.

Key Details

• Date of filing/announcement: July 24, 2026.
• Products named: Ubeslo (obicetrapib) and Evlarco (obicetrapib + ezetimibe FDC).
• Regulatory milestone: CHMP issued a positive opinion recommending marketing authorization (per EMA process).
• Filing detail: Press release attached as Exhibit 99.1; Form 8‑K signed by Mike Marino, Chief Legal Officer.

Why It Matters

• A positive CHMP opinion is a key regulatory milestone in the EU pathway and is typically followed by a decision from the European Commission on marketing authorization. For investors, this represents meaningful progress toward potential commercialization and market access in the European Union for NewAmsterdam’s obicetrapib products, which could affect future revenue opportunities if authorization is granted. The filing documents the company’s public disclosure of this regulatory development.