Longeveron Stock Soars After the FDA Grants Rare Pediatric Disease Designation

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Investing.com — Longeveron LLC (NASDAQ:LGVN) shareholders will be cheering the stock on Thursday after it rocketed over 192% on the FDA’s approval of Longeveron’s Lomecel-B for rare pediatric disease designation.

Lomecel-B has been designated for treating Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening heart defect in infants. The treatment is currently undergoing a Phase 2 trial following a positive Phase 1 trial. 

“We are encouraged by our Phase 1 clinical data, and the progress being made in the ongoing Phase 2 trial. Lomecel-B represents a unique cell therapy approach that could potentially be administered at the same time as surgery in these critically impacted infants,” said Longeveron co-founder and Chief Science Officer Joshua Hare.

Longeveron is currently assessing the treatment in Phase 1 and 2 clinical trials for Aging Frailty, Alzheimer’s disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and HLHS.

The company’s shares rose as high as $8.90 on the news, and are currently sitting around the $8.63 level. The company went public in February, opening up at $10 per share. However, subsequent study results disappointed investors, and its stock price touched a low of $2.84 on Wednesday.

The news is a timely boost for Longeveron, after five successive down days for its shares following its earnings release, which saw losses widen and revenue fall. In the report, the company told investors that it expects cash to cover requirements until at least the fourth quarter 2022.