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Longeveron Announces FDA Grants Type C Meeting Ahead of Data Readout for Pivotal Phase 2 Clinical Trial (ELPIS II) Evaluating Treatment for Hypoplastic Left Heart Syndrome (HLHS)
ELPIS II top-line trial results are anticipated in the third quarter of 2026Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated 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 program has the potential to address an unmet medical need with significant U.S. market opportunitiesEven with current standa
About this update from Longeveron Inc.
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