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Solid Biosciences Says SGT-003 Gets EU Orphan Drug Designation for Duchenne Muscular Dystrophy

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Solid Biosciences (SLDB) said Tuesday the European Commission has granted orphan drug designation to its investigational therapy SGT-003 for Duchenne muscular dystrophy.

This decision followed a positive recommendation from the European Medicines Agency's Committee for Orphan Medicinal Products, the company said.

SGT-003 already has been granted fast track, orphan drug, and rare pediatric disease designations by the US Food and Drug Administration, the company said, adding that the therapy is currently being tested in two clinical trials aimed at supporting regulatory approval in different countries.

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