Actuate Therapeutics receives FDA Rare Pediatric Disease Designation for elraglusib in Ewing sarcoma

ACTUATE THERAPEUTICS, INC.

FDA grants Rare Pediatric Disease Designation for elraglusib, a GSK-3β inhibitor, to treat Ewing sarcoma.
Designation makes elraglusib eligible for a Priority Review Voucher (PRV) upon future NDA approval; PRV can be sold.
Ongoing Phase 1/2 trial (NCT04239092) in relapsed/refractory EWS; topline Phase 1 data expected in 2H 2025.
Early data: two ongoing durable Complete Responses in first six patients; 8 patients enrolled to date.
Ewing sarcoma is the second most prevalent malignant tumor in children/adolescents; ~25% present with metastatic disease.

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