FDA Grants Rare Pediatric Disease Designation For Mesoblast' Revascor In Children With Heart Disease

(RTTNews) - Mesoblast Limited (MESO,MSB.AX) announced that the U.S. Food and Drug Administration has granted its allogeneic cell therapy Revascor (rexlemestrocel-L) a Rare Pediatric Disease Designation following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome or HLHS, a potentially life threatening congenital heart condition.

MESO closed Thursday's regular trading at $1.72 down $0.02 or 1.15%. But in the after-hours trading the stock gained $0.38 or 22.09%.

Rare Pediatric Disease Designation is granted by the FDA for certain serious or life-threatening diseases which primarily affect children. On FDA approval of a Biologics Licensing Application (BLA) for REVASCOR for the treatment of HLHS, Mesoblast may be eligible to receive a Priority Review Voucher (PRV) that can be redeemed for any subsequent marketing application or may be sold or transferred to a third party.

hypoplastic left heart syndrome is a severe congenital heart disease in which the left side of the heart does not fully develop and effective pumping of oxygenated blood by the left ventricle to the rest of the body is reduced. Without immediate surgery after birth, the prognosis is dismal with HLHS overall being responsible for 25% to 40% of all neonatal cardiac mortality. For More Such Health News, visit rttnews.com