Update from Solid Biosciences
In a press release earlier this week (December 1, 2025), Solid Biosciences announced that it received Rare Pediatric Disease designation from the U.S. FDA for SGT-212, the Company’s investigational gene therapy for FA.
Rare Pediatric Disease designation is granted by the FDA for serious and life-threatening diseases that primarily affect individuals under 18 years of age. The designation provides the Company with the potential to receive a pediatric priority review voucher (PRV), which can expedite the review for future Biologic License Applications.
