Longeveron (LGVN) Announces FDA Approves its Lomecel-B for Rare Pediatric Disease Designation to Treat Life-Threatening Infant Heart Condition

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Go back to Longeveron (LGVN) Announces FDA Approves its Lomecel-B for Rare Pediatric Disease Designation to Treat Life-Threatening Infant Heart Condition

U.S. Food and Drug Administration Approves Longeveron’s Lomecel-B for Rare Pediatric Disease Designation to Treat Life-Threatening Infant Heart Condition

November 18, 2021 8:00 AM EST

MIAMI, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, announced today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for Lomecel-B for the treatment of Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening congenital heart defect in infants. Lomecel-B, an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product, is currently being evaluated in a Phase 2 trial.

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