2024-01-19 06:07:53 ET
Mesoblast ( NASDAQ: MESO ) shares jumped ~12% premarket on Friday after the biotech firm received a rare pediatric disease designation for its allogeneic cell therapy Revascor (rexlemestrocel-L) from the U.S. Food and Drug Administration.
The designation was based on results from a randomized controlled trial in children with hypoplastic left heart syndrome, a potentially life threatening congenital heart condition.
In the trial conducted in 19 children, a single intramyocardial administration of Revascor at the time of staged surgery resulted in the desired outcome of significantly larger increases in left ventricular end-systolic and end-diastolic volumes over 12 months compared with controls as measured by 3D echocardiography, (p=0.009 & p=0.020 respectively).
Mesoblast Chief Executive Silviu Itescu said: "Given the impressive enlargement of the left chamber we have seen in these children treated with REVASCOR in the randomized controlled trial and the increased ability to successfully accomplish life-saving surgery, we plan to meet with FDA to discuss the potential for this trial to support accelerated approval in this indication."
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Mesoblast rises after cell therapy gets FDA rare pediatric disease designation