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Longeveron Announces FDA Approval Of IND Application For Stem Cell Therapy Laromestrocel As Potential Treatment For Pediatric Dilated Cardiomyopathy

Benzinga·07/08/2025 13:17:04
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  • Accepted IND application allows for development program to move directly to a Phase 2 pivotal registration clinical trial
  • Phase 2 clinical trial initiation anticipated in first half of 2026
  • Pediatric cardiomyopathies affect at least 100,000 children worldwide
  • Effective 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) --  Longeveron Inc. (NASDAQ:LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its stem cell therapy laromestrocel as a potential treatment for pediatric dilated cardiomyopathy (DCM). The accepted IND application provides for moving directly to a single Phase 2 pivotal registration clinical trial.