By Dean Seal

Mesoblast said regulators have granted their rare pediatric disease designation to its cell therapy Revascor for children with hypoplastic left heart syndrome.

The Australian biopharmaceutical company said Thursday that the special status from the Food and Drug Administration is granted for serious or life-threatening diseases that primarily affect children.

If the biologics licensing application for Revascor is approved, Mesoblast may now be eligible to receive a priority-review voucher from the FDA that can be used on any subsequent marketing application or transferred to a third party, the company said.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

January 18, 2024 19:13 ET (00:13 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.
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