LGVN - Longeveron climbs on FDA's compassionate use approval for Lomecel-B

Longeveron Inc. (LGVN) has surged ~45.5% in the premarket after the company announced that the FDA has granted approval for its experimental therapy Lomecel-B on a compassionate use basis to treat a child with Hypoplastic Left Heart Syndrome (“HLHS”).An allogeneic, bone marrow-derived medicinal signaling cell (“MSC”) product, Lomecel-B is manufactured under cGMP in Longeveron’s cell processing facility in Miami, Florida.“Our goal is to provide a new way to treat HLHS and we believe, based on previous studies, that the MSCs in Lomecel-B may improve ventricular and vascular function,” says Geoff Green, CEO of Longeveron.A rare congenital heart defect affecting an estimated ~1,000 babies per year in the U.S. HLHS can be fatal without a three-staged reconstructive surgery. Even with the surgery, the condition is linked to high mortality and a high rate of cardiac failure requiring heart transplantation.Last month, the company announced the completion of a Phase 1 clinical study for Lomecel-B to treat HLHS.

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Longeveron climbs on FDA’s compassionate use approval for Lomecel-B