Longeveron Announces Independent Data Monitoring Committee Positive Review and Recommendation to Complete Phase 2b Stem Cell Therapy Clinical Trial in Hypoplastic Left Heart Syndrome (HLHS)

Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct treatment for HLHS, a rare pediatric disease and orphan-designated indication DMC performed a risk-benefit assessment, identified no new safety concerns, and recommended continuation of the study as designed through completion This review represents the final planned independent safety assessment prior to completion of the trial ELPIS II top-line trial results anticipated in August 2026 MIAMI, May 11, 2026 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related conditions, today announced that the independent Data Monitoring Committee (DMC) has completed its final prespecified data review for the ongoing, fully enrolled, Phase 2b clinical trial (ELPIS II) evaluating laromestrocel (Lomecel-B®) as a potential adjunct therapy for hypoplastic left heart syndrome (HLHS). The DMC based its review on available data for all participating patients enrolled.
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