Actuate Therapeutics, Inc. (NASDAQ: ACTU) has announced that elraglusib, a novel GSK-3β inhibitor, has received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for its application in treating Ewing sarcoma (EWS).
Ewing sarcoma (EWS) is a notably metastatic sarcoma that originates in the bone, with its highest incidence occurring at the age of 15. It is classified as the second most common primary malignant tumor found in children and teenagers.
The FDA grants Rare Pediatric Disease Designation to serious or life-threatening diseases that affect fewer than 200 thousand people in the United States, focusing on conditions where the most severe symptoms are primarily observed in individuals under the age of 18.
“Receiving rare pediatric disease designation from the FDA underscores the urgent need for new treatment options for patients with EWS and recognizes elraglusib’s transformative potential,” said Daniel Schmitt, President & Chief Executive Officer of Actuate.
The designation of Rare Pediatric Disease allows Elraglusib to qualify for a Priority Review Voucher (PRV) following its marketing approval.
The previous trading day saw Actuate Therapeutics, Inc. (ACTU) shares trading between $8.86 and $9.39, besides a volume of 12.00 thousand shares. The stock closed Monday’s regular trading session at $8.97, marking 0.00 percent fall.
