Longeveron Shares Gain After Lead Product Gets FDA Orphan Drug Tag For Type Of Congenital Heart Defect

The FDA has granted Orphan Drug designation to Longeveron Inc's LGVN lead investigational product Lomecel-B for Hypoplastic left heart syndrome (HLHS).

• Lomecel-B is a cell-based therapy product derived from culture-expanded medicinal signaling cells (MSCs), sourced from the bone marrow of young, healthy adult donors. 
• See here Benzinga's Full FDA Calendar.
• HLHS is a congenital disability that affects normal blood flow through the heart. As the baby develops during pregnancy, the left side of the heart does not form correctly. 
• Hypoplastic left heart syndrome is one type of congenital heart defect.
• Last month, The FDA granted Rare Pediatric Disease (RPD) designation Lomecel-B for Hypoplastic Left Heart Syndrome.
• Also See: Longeveron Announces Clinical Collaboration To Study Cell Therapy Aging Treatment In Japan: Why It Matters.
• Price Action: LGVN shares are up 25% at $22.50 during the premarket session on the last check Friday.