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Longeveron® Announces U.S. FDA Approval of IND Application for a Phase 2 Pivotal Registration Study Evaluating Laromestrocel as a Treatment of Pediatric Dilated Cardiomyopathy (DCM)

Nataliya Agafonova Nataliya Agafonova, M.D., Chief Medical Officer, Longeveron Accepted IND application allows for development program to move directly to a Phase 2 pivotal registration clinical trialPhase 2 clinical trial initiation anticipated in first half of 2026Pediatric cardiomyopathies affect at least 100,000 children worldwideEffective treatment options are limited, with nearly 40% of children with DCM requiring a heart transplant or dying within two years of diagnosis MIAMI, July 08, 20

articleLongeveron Inc.July 8, 20257/company/longeveron-llc/news/longeveron-announces-u-fda-approval-131500260
Longeveron® Announces U.S. FDA Approval of IND Application for a Phase 2 Pivotal Registration Study Evaluating Laromestrocel as a Treatment of Pediatric Dilated Cardiomyopathy (DCM)

About this update from Longeveron Inc.

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More updates from Longeveron Inc.

dilated cardiomyopathyLongeveron Inc.cardiovascular diseaseChief Medical OfficerNataliya Agafonovaregenerative medicineLongeveronrare diseasesstem cell therapyFood and Drug AdministrationInvestigational New Drugcongestive heart failure