(RTTNews) - NewAmsterdam Pharma Company N.V. (NAMS), a late-stage clinical biopharmaceutical company and partner Menarini Group, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorisation for Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination) for the treatment of high cholesterol.
The positive CHMP opinion for the combo is for treatment of patients with primary hypercholesterolemia, both heterozygous familial and non-familial or mixed dyslipidemia.
Primary hypercholesterolemia refers to high levels of LDL cholesterol, and Familial hypercholesterolemia is an inherited condition that affects the way the body processes cholesterol. (Source: Mayo Clinic)
The positive CHMP recommendation is backed by data from NewAmsterdam's comprehensive clinical development program evaluating obicetrapib, including the Phase 3 BROADWAY, BROOKLYN and TANDEM trials.
Obicetrapib is an oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments.
Under the NewAmsterdam and Menarini licensing agreement, Menarini holds exclusive commercialization rights for obicetrapib in Europe and is responsible for regulatory interactions and commercialization activities throughout the region.
Supportive Trial Findings According to the company, the Phase 3 trials demonstrated statistically significant LDL-C reductions up to 40% with obicetrapib monotherapy versus placebo and approximately 50% with obicetrapib combined with ezetimibe versus placebo, with a tolerability profile comparable to placebo.
With a compelling clinical profile and the convenience of oral, once daily dosing with or without food, obicetrapib, if approved, has the potential to address a major unmet need for those not reaching LDL-C goals on existing therapies, the company said.
"Today's positive CHMP opinion is a significant milestone not just for NewAmsterdam but for a novel therapy, addressing LDL-C and other drivers of residual cardiovascular risk," said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam.
What's Ahead? The CHMP's positive opinion will now be reviewed by the European Commission (EC), which is expected to adopt a final decision on marketing authorisation.
In addition, the EC has authority to grant centralised marketing authorisation applicable across all European Union member states, as well as Iceland, Liechtenstein and Norway.
The company anticipates the European Commission's final verdict in the second half of 2026.
NewAmsterdam and Menarini continue to advance the clinical development of obicetrapib through multiple ongoing Phase 3 trials, including PREVAIL, a cardiovascular outcomes trial, as well as REMBRANDT and RUBENS.
Stock Performance The biotech stock NAMS has traded between $21.14 and $42.21 over the last year. The stock closed Friday's (July 24, 2026) trade at $29.64, down 2.98%.
In the after-hours market, NAMS is up 1.52% at $30.09.
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