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Get filing alertsCHMP recommends EU marketing authorization for obicetrapib cholesterol therapies
Filed July 24, 2026 · Period ending July 24, 2026 · ~1 min read
Key Changes
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European Medicines Agency's CHMP issued positive opinion recommending marketing authorization for Ubeslo (obicetrapib monotherapy) and Evlarco (obicetrapib/ezetimibe combination) for hypercholesterolemia; European Commission decision expected 2H 2026.
Item 8.01 verify on EDGAR → -
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CHMP recommendation based on Phase 3 data showing LDL-C reductions up to 40% with monotherapy and approximately 50% with combination therapy; approval would enable commercialization across EU member states plus Iceland, Liechtenstein, and Norway.
Exhibit 99.1 view on EDGAR → -
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Under Menarini partnership, NewAmsterdam entitled to tiered royalties (low double-digits to mid-twenties on net sales) and up to €833 million in clinical, regulatory, and commercial milestone payments; Menarini holds exclusive European commercialization rights.
Exhibit 99.1 view on EDGAR → -
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Phase 3 PREVAIL cardiovascular outcomes trial completed enrollment in April 2024 with over 9,500 patients randomized; trial designed to assess obicetrapib's potential to reduce major adverse cardiovascular events.
Exhibit 99.1 view on EDGAR →
Summary
NewAmsterdam Pharma announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for two obicetrapib-based cholesterol therapies: Ubeslo (10 mg monotherapy) and Evlarco (10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination).
The recommendation covers treatment of primary hypercholesterolemia, including heterozygous familial and non-familial or mixed dyslipidemia. A positive CHMP opinion typically leads to European Commission approval within approximately $5.5 billion three months, with a final decision expected in the second half of 2026.
For retail investors, this represents a critical regulatory milestone that could unlock significant near-term value. Under NewAmsterdam's licensing agreement with Menarini Group, the company will receive tiered royalties ranging from low double-digits to mid-twenties on European net sales, plus up to €833 million in milestone payments tied to clinical, regulatory, and commercial achievements. The CHMP recommendation is based on Phase 3 trial data demonstrating statistically significant LDL-C reductions up to 40% with monotherapy and approximately 50% with combination therapy. Separately, the company's Phase 3 PREVAIL cardiovascular outcomes trial completed enrollment in April 2024 with over 9,500 patients; successful MACE reduction data from this trial would further strengthen the commercial case for obicetrapib beyond cholesterol lowering alone.
Section-by-Section Diff
Event · Item 8.01 — Other Events
Item 8.01 — Other Events filed; see Key Changes for terms.
Added in current filing · verify on EDGAR →
the Company and the Menarini Group have received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency recommending marketing authorization for Ubeslo® (obicetrapib monotherapy) and Evlarco® (obicetrapib plus ezetimibe fixed-dose combination)
The European Medicines Agency's CHMP has recommended marketing authorization for two obicetrapib-based products: Ubeslo as monotherapy and Evlarco as a fixed-dose combination with ezetimibe. A positive CHMP opinion typically leads to European Commission approval within approximately $5.5 billion three months, enabling commercial launch in the EU market.
Event · Exhibit 99.1
Added in current filing · view on EDGAR →
NewAmsterdam is entitled to tiered double-digit percentage royalties ranging from the low double-digits to mid-twenties on net sales in the Menarini Territory and up to an additional €833 million upon the achievement of various clinical, regulatory and commercial milestones.
Under the licensing agreement with Menarini Group, NewAmsterdam will receive tiered royalties on European sales ranging from low double-digit to mid-twenties percentages. Additionally, the company is eligible for up to €833 million in milestone payments tied to clinical, regulatory, and commercial achievements. Menarini holds exclusive commercialization rights in Europe and is responsible for regulatory interactions and commercialization activities throughout the region.
Added in current filing · view on EDGAR →
The Company commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE. The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients.
NewAmsterdam completed enrollment of its Phase 3 PREVAIL cardiovascular outcomes trial in April 2024, randomizing over 9,500 patients. This trial is designed to assess whether obicetrapib can reduce major adverse cardiovascular events (MACE). Successful MACE reduction data would significantly strengthen the commercial case for obicetrapib beyond LDL-C lowering alone.
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Figures/quotes linked to EDGAR · Narrative written by AI · Jul 27, 2026 · How we verify