Solid Biosciences Receives EU Orphan Designation for SGT-212 in Friedreich's Ataxia

09:29 AM EDT, 10/26/2026 (MT Newswires) -- Solid Biosciences (SLDB) said Monday the European Commission has granted orphan drug designation to its SGT-212 investigational gene therapy for Friedreich's ataxia, a rare genetic disease affecting neurological and cardiac function. Five participants have been dosed in a phase 1b trial, with no treatment-related serious adverse events reported as of Oct. 5, the company said. The investigational therapy is administered through a combination of MRI-guided delivery to the brain with intravenous delivery intended to target the heart and other tissues, the company said. Solid Biosciences said it expects to report initial data in Q1 2027. SGT-212 also holds fast track, orphan drug and rare pediatric disease designations from the US Food and Drug Administration, the company said. Solid Biosciences shares were up more than 5% in premarket activity Monday.