FDA Clears Dual-Route Gene Therapy SGT-212 for Friedreich's Ataxia
Boston – October 28, 2026 -- People living with Friedreich's ataxia (FA) have a new gene therapy candidate heading toward human testing: Solid Biosciences says the FDA has cleared its Investigational New Drug (IND) application for SGT-212, with a Phase 1b trial planned for the second half of 2025.
SGT-212 attacks FA through two delivery routes
The company describes SGT-212 as the first gene therapy in the industry to use a dual route of administration. It delivers full-length frataxin protein in two ways: