Longeveron's Phase 2b trial for HLHS stem cell therapy gets positive safety review, continues to completion

Longeveron announced that the independent Data Monitoring Committee (DMC) has completed its final safety review of the fully enrolled Phase 2b clinical trial (ELPIS II) testing laromestrocel as a treatment for hypoplastic left heart syndrome (HLHS). The DMC found no new safety concerns and recommended the trial continue as planned. This trial involves 40 pediatric patients and aims to improve outcomes for HLHS, a rare congenital heart defect with high mortality despite surgery. Top-line results are expected in August 2026, potentially advancing a novel stem cell therapy with FDA orphan and fast track designations.