Longeveron Inc. (NASDAQ: LGVN) stock gained by 135.27% at last close however its hiked by 50.95% in the after-hours trading session, as well. Longeveron is a clinical-stage biotechnology business focused on creating cellular therapeutics for age-related and life-threatening diseases.
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LGVN stock’ Significant Update
The FDA has given Lomecel-B RPD designation for the cure of Hypoplastic Left Heart Syndrome (HLHS), a severe and life-threatening congenital heart condition in neonates, according to Longeveron. In a Phase 2 trial, Lomecel-B, an experimental allogeneic bone marrow-derived medical signalling cell (MSC) product, is being examined.
Every year, about 1,000 babies in the United States are delivered with HLHS. The left ventricle of HLHS new-borns is underdeveloped, impairing the heart’s ability to pump blood to the whole body. Without surgical treatment, HLHS is frequently fatal. Three surgical procedures are conducted over a 5-year period to enable the right ventricle to be designed to pump blood to the body. Longeveron is testing the safety of injecting Lomecel-B into the right ventricle during the second operation (4–6 months of age), as well as the influence on heart function and other health outcomes.
Longeveron recently released the findings of their Lomecel-B safety-focused Phase I clinical research in HLHS participants. The cells were well accepted when cardiologists administered Lomecel-B directly into the newborns’ hearts during surgery, with no severe negative cardiac events or infections linked to the exploratory treatment.
Between 2 and 3.5 years after surgery, 100% of the infants who participated in the Phase 1 trial (n=10) were living and had not needed a transplant. Other health indicators, such as weight gain and growth patterns, were comparable to that of healthy babies.
The FDA may give RPD status to disorders that mainly affect children aged 18 and under and impact fewer than 200,000 people in the United States. If the FDA approves Lomecel-B for the cure of HLHS, Longeveron may also be qualified for a priority review voucher (PRV). It can happen if the application for the medicine meets specific criteria and is approved by September 30, 2026, as required by existing law.