Actuate Therapeutics: FDA Grants Pediatric-Disease Status to Ewing Sarcoma Treatment

Dow Jones

Nov 12, 2024

By Denny Jacob

Actuate Therapeutics said its treatment for Ewing sarcoma was granted rare pediatric-disease designation from the Food and Drug Administration.

Chief Executive Daniel Schmitt said early clinical data from the ongoing Phase 1/2 trial of elraglusib shows promising anti-tumor activity with objective tumor responses.

Ewing sarcoma is a highly metastatic form of sarcoma that originates in bone with a peak incidence at the age of 15, the clinical-stage biopharmaceutical company said.

The FDA's pediatric-disease designation is granted for serious or life-threatening ailments that affect fewer than 200,000 people in the U.S., and which the serious or life-threatening manifestations primarily affect individuals less than 18 years old.

Write to Denny Jacob at denny.jacob@wsj.com

(END) Dow Jones Newswires

November 12, 2024 08:34 ET (13:34 GMT)

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