Evlarco (obicetrapib/ezetimibe) / NewAmsterdam Pharma, Tanabe Pharma - LARVOL DELTA

NewAmsterdam Pharma and Menarini Group Receive European Commission Approval for Ubeslo (Obicetrapib Monotherapy) and Evlarco (Obicetrapib Plus Ezetimibe Fixed-Dose Combination) (Yahoo Finance) - "The European Commission approval follows the positive opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) and is supported by data from NewAmsterdam's comprehensive clinical development program evaluating obicetrapib, including the Phase 3 BROADWAY, BROOKLYN and TANDEM trials..."

EMA approval • Cardiovascular • Dyslipidemia • Heterozygous Familial Hypercholesterolemia • Homozygous Familial Hypercholesterolemia

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 | Active, not recruiting | Sponsor: NewAmsterdam Pharma | Recruiting ➔ Active, not recruiting

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

Obicetrapib-ezetimibe combination therapy: a novel oral strategy for enhanced lipid lowering. (PubMed, Cardiovasc Res) - No abstract available

Journal

NewAmsterdam Pharma and Menarini Group Receive Positive CHMP Opinion Recommending Marketing Authorization for Ubeslo (Obicetrapib Monotherapy) and Evlarco (Obicetrapib Plus Ezetimibe Fixed-Dose Combination) (GlobeNewswire) - "European Commission decision expected in 2H26...The positive CHMP recommendation is supported by data from NewAmsterdam's comprehensive clinical development program evaluating obicetrapib, including the Phase 3 BROADWAY, BROOKLYN and TANDEM trials..."

CHMP • EMA approval • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia

Lipid-Lowering Efficacy and Safety of Obicetrapib Alone and as an Add on Therapy: A Meta-Analysis of Randomized Controlled Trials. (PubMed, Cardiol Rev) - "As an add-on therapy to ezetimibe, obicetrapib yielded greater reduction in low-density lipoprotein [MD, -51.99 (95% CI, -61.61 to -42.37), P < 0.001] and non-HDL [MD, -50.32 (-55.42 to -45.21), P < 0.001]. No significant effects were observed when combined with statins."

Journal • Retrospective data • Dyslipidemia • 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

Trial initiation date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • APOB

Upcoming Milestones and Ongoing Trials (GlobeNewswire) - "PREVAIL interim analysis planned for 4Q2026 with result expected in 1Q2027...Following the successful completion and positive topline results of the Phase 3 BROADWAY, TANDEM, and BROOKLYN trials, NewAmsterdam plans to announce additional clinical data from these trials relating to obicetrapib and the fixed-dose combination ('FDC') of obicetrapib plus ezetimibe during 2026....Additionally, NewAmsterdam expects to initiate a new clinical trial evaluating obicetrapib for the prevention of early Alzheimer’s disease in 2026."

New trial • P3 data: top line • Trial status • Alzheimer's Disease • Atherosclerosis • Cardiovascular • Heterozygous Familial Hypercholesterolemia

Decisions on regulatory approval from EMA, UK, and Switzerland for obicetrapib and obicetrapib/ezetimibe fixed-dose combination expected in 2H26, and based on the outcomes, with potential launches by Menarini in 4Q26 in Germany and the UK (GlobeNewswire)

Approval • Launch • Atherosclerosis • Cardiovascular • Heterozygous Familial Hypercholesterolemia

REMBRANDT: A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque (clinicaltrials.gov) - P3 | N=300 | Active, not recruiting | Sponsor: NewAmsterdam Pharma | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2027 ➔ Feb 2028 | Trial primary completion date: Dec 2026 ➔ Nov 2027

Enrollment closed • Trial completion date • Trial primary completion date • Atherosclerosis • Cardiovascular • Coronary Artery Disease

Obicetrapib and ezetimibe enhance LDL receptor-mediated VLDL-clearance and regress atherosclerosis on atorvastatin background. (PubMed, J Lipid Res) - "In summary, obicetrapib alone and with ezetimibe reduces non-HDL-C by enhancing LDL receptor-mediated VLDL clearance, thereby synergistically reducing atherosclerosis. Triple treatment with obicetrapib, ezetimibe and atorvastatin regresses pre-existent atherosclerotic lesions."

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • Metabolic Disorders • APOE

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