NewAmsterdam Pharma (NAMS) shares fell 2.85% to $22.14 on September 10 at the 12th Annual Cantor Fitzgerald Global Healthcare Conference, leaving the stock near the low end of its 52-week range of $21.955 to $42.205.
CFO Ian Somaiya used the conference to outline the latest data and timelines for obicetrapib, the company's lead CETP inhibitor targeting cardiovascular disease. A 10-milligram dose achieves 97% to 98% CETP inhibition, and obicetrapib monotherapy lowers LDL cholesterol by 35% to 40%. When combined with ezetimibe in a fixed-dose formulation, LDL reduction exceeds 50%.
The BROADWAY trial demonstrated a 21% reduction in major adverse cardiovascular events (MACE) at one year. The larger PREVAIL study is powered for a 20% MACE benefit and is using a p-value threshold of 0.01 for its primary endpoint — a stricter cutoff the FDA requested to support a single-trial approval pathway. Prevail data is anticipated by the end of 2024, with interim results expected in the first quarter of 2025. The four-year PREVAIL study and the RUBENS trial will both continue through 2027.
Researchers modified PREVAIL's 4-point MACE definition by replacing urgent revascularization with total revascularization, increasing available events by approximately 20% and shifting the trial's target from 950 events to roughly 20% more. Somaiya noted that blinded PREVAIL data aligns closely with the unblinded BROADWAY results.
An Alzheimer's substudy within BROADWAY showed obicetrapib benefits across roughly six biomarkers, notably neurofilament light (NfL) and p-tau217. Between 25% and 30% of participants in both PREVAIL and BROADWAY are APOE4 carriers, who are at elevated risk for Alzheimer's disease. The REMBRANDT study may produce data by the end of 2025.
In Europe, the European Medicines Agency's CHMP has issued a positive recommendation for obicetrapib, and formal EMA approval is expected imminently. Partner Menarini will begin country-by-country launches, starting with Germany and the United Kingdom.
Somaiya described a disciplined capital strategy focused on "maximizing every EUR" of spend. Research and development outlays are expected to decline as clinical studies conclude by 2027, while overall company spending will rise only modestly as it transitions toward commercial operations. Sales force expansion is planned incrementally.
NewAmsterdam maintains a current ratio of 9.03, with liquid assets substantially exceeding short-term obligations and cash holdings topping debt, according to InvestingPro data.
