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 [e-mail]

(END) Dow Jones Newswires

01-16-24 0835ET