NewAmsterdam Pharma Advances Phase 3 Pipeline and Strengthens Financial Position—Interim PREVAIL Analysis on the Horizon

Major Clinical Milestones Expected in 2026 as Obicetrapib Development Progresses

NewAmsterdam Pharma (NASDAQ:NAMS) is accelerating its efforts to address unmet needs in cardiovascular disease (CVD) treatment. In its latest quarterly update, the company confirmed completed enrollment in major Phase 3 trials, anticipated regulatory decisions, and promising signals for its lead compound, obicetrapib. With a slate of critical milestones ahead, including interim and topline data readings in 2026, the next 18 months could redefine the company’s clinical and commercial outlook.

PREVAIL Trial Timing and Early Signals Spark Optimism

Clinical momentum remains strong: NewAmsterdam has completed enrollment in its PREVAIL cardiovascular outcomes trial (CVOT), enrolling over 9,500 patients with established atherosclerotic disease whose LDL-C remains inadequately controlled despite maximal therapy. Notably, an interim analysis is planned for the fourth quarter of 2026, with results expected in the first quarter of 2027. Early blinded analysis suggests the trial’s Year 1 major adverse cardiovascular event (MACE) rate is consistent with prior positive studies, while Year 1-to-Year 2 rates are even better than expected, fueling optimism for the upcoming interim look.

Obicetrapib Shows Benefits Beyond LDL-C Lowering

Recent analyses of the BROOKLYN and BROADWAY Phase 3 trials indicate obicetrapib’s impact may extend beyond LDL-C reduction. Data presented at the American College of Cardiology meeting showed:

• Slower kidney function decline: Annualized drop in eGFR was -0.41 for obicetrapib vs. -1.08 for placebo.
• Lower renal event rates: Composite renal outcomes nominally favored obicetrapib over 12 months.
• Favorable MACE associations: Higher small/medium LDL-P discordance linked independently to more MACE events in high-risk patients, supporting further patient subtyping and targeting.
• Alzheimer’s biomarker benefit: BROADWAY trial data showed significantly reduced progression in plasma p-tau217—a key Alzheimer’s disease marker—over 12 months versus placebo.

Pipeline Momentum: Multiple Late-Stage Programs Advancing

Beyond PREVAIL, NewAmsterdam’s two other Phase 3 programs are moving forward:

• REMBRANDT: Fully enrolled as of March 2026; topline data expected by year-end 2026. The trial evaluates obicetrapib plus ezetimibe fixed-dose combination on coronary plaque reduction using advanced imaging.
• RUBENS: Enrolling patients with type 2 diabetes or metabolic syndrome. Topline results targeted for late 2026.

Additionally, a new study of obicetrapib in early Alzheimer’s disease is on track to start in 2026—broadening the company’s therapeutic footprint.

Financial Position Remains Strong Despite R&D Investments

NewAmsterdam ended the quarter with $707.3 million in cash and marketable securities, after absorbing continued research and development costs for its advancing pipeline. R&D spend decreased year-on-year due in part to the completion of early phase 3 trials, though the net loss widened, reflecting non-cash changes in warrant liabilities and other items.

Key Regulatory and Clinical Milestones Ahead

With regulatory decisions on approval for obicetrapib and its fixed-dose combination targeted for the second half of 2026 in Europe and the UK, commercial launches with the Menarini Group could follow late in the year. Conference calls and ongoing data releases—especially PREVAIL’s interim analysis—will be closely watched by the market and clinicians alike.

Takeaway: Strong Execution Sets the Stage for a Defining 2026

NewAmsterdam Pharma is demonstrating effective clinical execution and maintaining a robust capital base even as it ramps up for major data and regulatory milestones. The next chapters—especially the imminent PREVAIL data and European regulatory news—will reveal whether obicetrapib can become a new mainstay in the treatment of challenging lipid disorders and beyond. For investors and clinicians, the conglomeration of upcoming events provides both a catalyst and a test of the company's long-term strategic thesis.

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