Longeveron Inc was granted a rare-pediatric-disease designation by the FDA for treating congenital heart defects in infants, according to a press release by Longeveron on Thursday.

  • The Miami clinical-stage biotechnology company is now studying Lomecel-B in a Phase 2 trial.
  • The FDA’s rare-pediatric-disease designation covers various life-threatening diseases that affect not less than 200,000 people in the United States under 18 years old.
  • Longeveron stated that 1,000 babies are born with hypoplastic left-heart syndrome every year in the U.S. that impairs their heart’s ability to pump blood throughout the body.
  • Joshua Hare Longeveron, co-founder and Chief Science Officer, stated that they are encouraged by Phase 1 clinical data and the progress in the ongoing Phase 2 trial.

Longeveron further stated that Lomecel-B represents a unique cell therapy strategy that could be administered at the same time as surgery on severely affected infants. LGVN up +90.83%, Pre-market trading.