Actuate Therapeutics announces U.S. FDA granted ODD for elraglusib

Actuate Therapeutics announced that the U.S. Food and Drug Administration, FDA, has granted Orphan Drug Designation, ODD, for elraglusib, a novel GSK-3beta inhibitor for treatment of soft tissue sarcoma, STS. “We are pleased to receive the ODD from the FDA, which underscores elraglusib’s potential to address the significant yet unmet medical needs for patients with advanced cancers,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “Elraglusib is a leading GSK-3beta inhibitor that has demonstrated a favorable safety profile and antitumor activity across several solid tumors including melanoma, Ewing sarcoma, colorectal and pancreatic cancers. We look forward to the continued development of elraglusib and working closely with regulators to deliver its promise to cancer patients.”