obicetrapib/ezetimibe / NewAmsterdam Pharma, Tanabe Pharma - LARVOL DELTA

LIPID-LOWERING EFFICACY AND SAFETY OF OBICETRAPIB: A META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS (ACC 2026) - "As an add-on therapy to Ezetimibe, Obicetrapib yielded greater reduction in LDL (MD -51.99 [95% CI: -61.61 to -42.37]) and non-HDL (MD -50.32 [-55.42 to -45.21]). Obicetrapib was significantly associated with reductions in the lipid parameters, both as a monotherapy and as an adjunctive therapy."

Retrospective data • Acute Coronary Syndrome • Cardiovascular • Coronary Artery Disease • Heart Failure • Reperfusion Injury • APOA1 • APOB • APOE

RUBENS: A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: NewAmsterdam Pharma | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • APOB

Upcoming Milestones and Ongoing Trials (The Manila Times) - "...NewAmsterdam plans to announce additional data from these trials relating to obicetrapib and the FDC of obicetrapib plus ezetimibe during 2026...REMBRANDT Phase 3 trial...The trial is expected to complete enrollment of approximately 300 patients in 2026...Initiated in December 2025, the RUBENS trial will evaluate obicetrapib alone or in combination with ezetimibe in patients with type 2 diabetes or metabolic syndrome that require additional lowering of LDL-C despite treatment with available therapy. The trial is expected to enroll approximately 300 patients, with topline data expected by year end 2026....Additionally, NewAmsterdam expects to initiate a new clinical trial evaluating obicetrapib in early Alzheimer’s disease patients in 2026."

Clinical data • New trial • Alzheimer's Disease • Atherosclerosis • Cardiovascular • Dyslipidemia • Type 2 Diabetes Mellitus

Approval decisions from EMA, UK and Switzerland regulators for obicetrapib and obicetrapib/ezetimibe fixed dose combination expected in 2H26 (The Manila Times)

Approval • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia

Key Expected 2026 Milestones... (Yahoo Finance) - "EMA approval decision for obicetrapib and obicetrapib/ezetimibe fixed dose combo expected in 2H26...REMBRANDT Phase 3 trial...The trial is expected to complete enrollment of approximately 300 patients in 2026....Additionally, NewAmsterdam expects to initiate a new clinical trial evaluating obicetrapib in early Alzheimer’s disease patients in 2026."

EMA approval • Enrollment status • New trial • Alzheimer's Disease • Cardiovascular • Dyslipidemia • Heterozygous Familial Hypercholesterolemia

RUBENS: A Randomized Phase 3 Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: NewAmsterdam Pharma

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • APOB

Menarini Group's Obicetrapib and Obicetrapib/Ezetimibe Marketing Authorisation Applications Accepted for Review by the European Medicines Agency (EMA) for the Treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia (PRNewswire) - "Obicetrapib: The submission is supported by results from the pivotal Phase 3 studies BROOKLYN and BROADWAY, conducted by NewAmsterdam Pharma....Obicetrapib/Ezetimibe:The submission is supported by results from the pivotal Phase 3 study TANDEM, conducted by NewAmsterdam Pharma..."

EMA filing • Dyslipidemia • Heterozygous Familial Hypercholesterolemia