NewAmsterdam Loss Widens as European Drug Review Advances
Cash and marketable securities declined to $678.3 million at June 30.
NewAmsterdam Pharma (NAMS), a clinical-stage biopharmaceutical company, secured a positive European regulatory recommendation for obicetrapib as its second-quarter net loss widened.
The positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use marked an advance from prior quarters, when the applications remained under review. The recommendation covered both 10-milligram obicetrapib monotherapy and a 10-milligram obicetrapib and 10-milligram ezetimibe fixed-dose combination.
Revenue fell about 81% to $3.7 million from $19.1 million a year earlier, when NewAmsterdam recorded a $16.1 million Menarini development-cost installment. The latest quarter’s revenue came from the Menarini supply agreement and increased from $3.0 million in the first quarter.
The net loss widened to $64.1 million from $17.4 million a year earlier and $48.4 million in the first quarter. Research-and-development expense rose 52% from a year earlier to $41.7 million as NewAmsterdam initiated trials, advanced existing studies and added personnel costs. Total operating expenses increased 25% to $68.6 million, widening the operating loss to $64.9 million.
New clinical analyses added support for obicetrapib’s cardiovascular and neurological profile. A pooled BROADWAY and BROOKLYN analysis found a 23% observed reduction in major adverse cardiovascular events, compared with the previously reported 21% reduction from BROADWAY alone. Changes in LDL cholesterol and lipoprotein(a) jointly mediated 84.5% of the observed benefit.
NewAmsterdam also reported significantly lower 12-month changes in the Alzheimer’s biomarker plasma p-tau217 versus placebo among all 1,535 patients in the BROADWAY analysis and among 367 ApoE4 carriers. The findings supplied detail beyond earlier disclosures of positive biomarker results.
The REMBRANDT Phase 3 trial completed enrollment of 323 patients in March, while the roughly 300-patient RUBENS trial remained on track for topline data at year-end 2026. An interim PREVAIL analysis remains planned for the fourth quarter, with results expected in the first quarter of 2027. The European Commission’s final decision on obicetrapib is expected later in 2026.