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Longeveron® Announces Completion of Enrollment of Pivotal Phase 2b Clinical Trial Evaluating Laromestrocel as a Treatment for Hypoplastic Left Heart Syndrome (HLHS)

Nataliya Agafonova Nataliya Agafonova, M.D., Chief Medical Officer, Longeveron Top-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-monthsLaromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II results are positiveU.S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan drug designation, and Fast track designationLaromestrocel HLHS progra

articleLongeveron Inc.June 24, 20259/company/longeveron-llc/news/longeveron-announces-completion-enrollment-pivotal-103000678
Longeveron® Announces Completion of Enrollment of Pivotal Phase 2b Clinical Trial Evaluating Laromestrocel as a Treatment for Hypoplastic Left Heart Syndrome (HLHS)

About this update from Longeveron Inc.

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More updates from Longeveron Inc.

Hypoplastic Left Heart SyndromeLongeveronLongeveron Inc.clinical stageHLHSregenerative medicineChief Medical OfficerNataliya AgafonovaOrphan Drug designationpotential