Actuate Gets FDA Orphan Designation for Elraglusib in Soft Tissue Sarcomas
By Colin Kellaher
Actuate Therapeutics has won Food and Drug Administration orphan-drug designation for its lead investigational drug product in a group of rare cancerous tumors.
Actuate on Wednesday said the designation covers elraglusib for the treatment of soft tissue sarcoma, which are tumors that start in muscles, tendons and fat cells.
The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.
Fort Worth, Texas, clinical-stage biopharmaceutical company Actuate said elraglusib has shown a favorable safety profile and antitumor activity across several solid tumors, including melanoma, Ewing sarcoma, colorectal and pancreatic cancers.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 11, 2024 08:33 ET (12:33 GMT)
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