$NAMS

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NewAmsterdam Pharma Gets EU Approval for Ubeslo, Evlarco

NewAmsterdam Pharma (NAMS) said Monday that the European Commission approved Ubeslo, an obicetrapib monotherapy, and Evlarco, an obicetrapib-ezetimibe combination, for certain patients with elevated cholesterol.The approvals mark the first regulatory authorization for obicetrapib worldwide and follow a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, the company said.The applications were supported by Phase 3 BROADWAY, BROOKLYN and TANDEM trials, which showed LDL-C reductions of up to 40% with obicetrapib monotherapy and about 50% with the combination therapy versus placebo.NewAmsterdam and Menarini are advancing obicetrapib in additional Phase 3 trials, including PREVAIL, REMBRANDT and RUBENS, it added.Price: $22.71, Change: $+0.22, Percent Change: +0.96%

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Wire59d ago

NewAmsterdam Pharma Says EMA Committee Recommends Approval of Cholesterol Treatments

NewAmsterdam Pharma (NAMS) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorization for its cholesterol treatments Ubeslo and Evlarco.The recommendation was based on phase 3 trial data showing LDL cholesterol reductions of up to 40% with Ubeslo and about 50% with the obicetrapib-ezetimibe combination Evlarco.The European Commission will review the CHMP opinion and is expected to issue a final decision in the second half of 2026, NewAmsterdam Pharma said.Shares of NewAmsterdam were up nearly 1% in Friday trading.Price: $30.81, Change: $+0.26, Percent Change: +0.85%

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Wire83d ago

NewAmsterdam Pharma's Obicetrapib Could Capture Market Share, RBC Capital Markets Says

NewAmsterdam Pharma's (NAMS) obicetrapib could be a strong second option for patients with high LDL cholesterol, particularly if an ongoing phase 3 trial can recapitulate a 20% reduction in major adverse cardiovascular events, RBC Capital Markets said in a note Tuesday.The brokerage said its survey showed 23% of 174 patients are not satisfied with existing treatment regimens, while a "significant" niche of patients may use obicetrapib as an add-on or switch therapy, suggesting an addressable market of up to $40 billion. RBC said it now estimates US sales of about $2.1 billion by 2035.Additional benefits offered by obicetrapib are potential differentiators that may appeal to key opinion leaders, but the brokerage said its survey showed that these will not be a major driver of use.RBC Capital Markets raised its price target on NewAmsterdam Pharma to $51 from $47, with an outperform, speculative risk rating.Price: $33.86, Change: $-0.01, Percent Change: -0.03%

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