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

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