Mesoblast (ASX:MSB) secured a regenerative advanced therapy designation from the US Food and Drug Administration for Revascor-branded rexlemestrocel-L cell therapy for pediatric patients with congenital heart disease, according to a Thursday filing with the Australian bourse.

The status was granted following results from a clinical trial investigating the use of the therapy in children with hypoplastic left heart syndrome (HLHS), the filing said.

Revascor was previously granted by the health regulator with both a rare pediatric disease designation and an orphan drug designation for pediatric patients with HLHS, the filing added.

The company's shares tumbled almost 8% in recent Thursday trade but earlier hit their highest since August 2021.

Price (AUD): $1.62, Change: $-0.14, Percent Change: -7.95%