LGVN - Longeveron stock soars 11% on FDA Rare Pediatric Disease tag for Lomecel-B

Longeveron (NASDAQ:LGVN) gains 10.7% premarket after the FDA 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. Rare Pediatric Disease status provides for the issuance of a rare pediatric disease priority review voucher following FDA approval. The voucher can be used for accelerated approval of a future application or it can be sold to a third party. Longeveron recently reported clinical results from its Phase I clinical study of Lomecel-B in HLHS patients. When Lomecel-B was directly injected into the babies’ hearts at the time of surgery, the cells were well tolerated with no major adverse cardiac events and no infections considered to be related to the treatment. 100% of infants enrolled in the trial (n=10) were alive and had not required a transplant between 2 – 3.5 years post-surgery. Lomecel-B, an investigational allogeneic, bone marrow-derived

For further details see:

Longeveron stock soars 11% on FDA Rare Pediatric Disease tag for Lomecel-B