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  • News bot Jan. 9, 2026, 1:04 p.m.

    📋 NewAmsterdam Pharma Company N.V. (NAMS) - Clinical Trial Update

    Filing Date: 2026-01-09

    Accepted: 2026-01-09 08:00:27

    Event Type: Clinical Trial Update

    Event Details:

    NewAmsterdam Pharma (NAMS) Announces Clinical Trial Update NewAmsterdam Pharma (NAMS) provided an update on its clinical development programs. Clinical Development Highlights:
    • Clinical Stage: Phase 3, Phase 3 trial
    • Update Type: Trial Timeline Adjustment
    • Primary Factors: Patient Enrollment, Regulatory Process
    • Collaboration: FDC
      • expected by year end 2026
      • expected in 2H26. In PREVAIL, we are encouraged by the rate of overall MACE events (blinded) in this cardiovascular outcomes trial (“CVOT”), which suggest that the initial 12 month rate is tracking in line with the overall rate observed in the Phase 3 BROADWAY trial,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “We are also excited to announce the RUBENS trial enrolled its first few patients in December and could allow for additional label enhancements, if approved, for patients with Type 2 Diabetes and/or Metabolic Syndrome that are not at their LDL-C risk-based goals. We expect topline results from the trial by the end of 2026
      • expected in 2H26 ---- Phase 3 PREVAIL CVOT overall event rate tracking in line with observed rate in BROADWAY ---- First patient enrolled in RUBENS Phase 3 trial of obicetrapib and obicetrapib/ezetimibe fixed dose combo (FDC) in patients with metabolic syndrome ---- Year-end cash, cash equivalents and marketable securities balance of approximately $729 million (unaudited) -- Naarden, the Netherlands and Miami, USA; January 9, 2026

    🔬 Clinical Development Pipeline (NewAmsterdam Pharma Company N.V.):

    Product Type Development Stage Therapeutic Area Source
    Obicetrapib 10 mg DRUG Phase PHASE3 Lipidemia ClinicalTrials.gov
    Placebo OTHER Phase PHASE3 Lipidemia ClinicalTrials.gov
    obicetrapib 10 mg + ezetimibe 10 mg FDC daily DRUG Phase PHASE3 Lipidemia ClinicalTrials.gov
    Obicetrapib 10mg DRUG Phase PHASE2 Antioxidant Absorption ClinicalTrials.gov
    Ezetimibe Placebo OTHER Phase PHASE3 Dyslipidemias ClinicalTrials.gov
    Obicetrapib Placebo OTHER Phase PHASE3 Dyslipidemias ClinicalTrials.gov
    Combination Therapy placebo OTHER Phase PHASE3 Dyslipidemias ClinicalTrials.gov
    Monotherapy ezetimibe DRUG Phase PHASE3 Dyslipidemias ClinicalTrials.gov
    Monotherapy obicetrapib DRUG Phase PHASE3 Dyslipidemias ClinicalTrials.gov

    💼 Business Developments:

    • Partnership
    • Acquisition: Not available
    • Licensing
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: NewAmsterdam Pharma
    • CIK: 0001936258
    • Ticker Symbol: NAMS
    • Period End Date: 2026-01-09
    • Document Type: 8-K

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