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The FDA has granted Rare Pediatric Disease (RPD) designation for Longeveron Inc's (NASDAQ: LGVN) Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS).
HLHS is 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. Longeveron recently reported Phase 1 results.
When cardiac surgeons injected Lomecel-B directly 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 investigational treatment.
One hundred percent of infants enrolled in the Phase 1 trial (n=10) were alive and had not required a transplant between 2 – 3.5 years post-surgery.
Longeveron may be eligible to receive a priority review voucher.
Price Action: LGVN shares are 141.8% at $7.16 during the market session on the last check Thursday.
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