Longeveron gets FDA approval for pediatric heart disease trial
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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)
July 8, 2025 9:15 AM EDTAccepted 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, 2025 (GLOBE NEWSWIRE) --... More
