Solid Biosciences Gets Orphan Drug Designation for SGT-003
By Chris Wack
Solid Biosciences has been granted orphan drug designation from the U.S. Food and Drug Administration for SGT-003, the company's next-generation Duchenne muscular dystrophy gene therapy candidate.
The life-science company's SGT-003 received Fast Track Designation last month.
The company said it is currently in the process of securing approvals from the institutional review boards at the clinical trial sites for the planned Phase 1/2 clinical trial of SGT-003 and expects to begin patient screening shortly thereafter.
Patient dosing in the trial is expected to begin in mid-to-late first quarter of 2024.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 16, 2024 08:35 ET (13:35 GMT)
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