By Editor , 28 October 2026

FDA Clears Dual-Route Gene Therapy SGT-212 for Friedreich's Ataxia

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FDA Clears Dual-Route Gene Therapy SGT-212 for Friedreich's Ataxia

Boston – October 27, 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:

By Editor , 27 October 2026

Solid Biosciences Doses First Patient in FALCON Gene Therapy Trial

Global – October 27, 2026 -- Solid Biosciences has dosed the first participant in FALCON, a Phase 1b trial of SGT-212, its investigational gene therapy for Friedreich's ataxia (FA), and expects to release an initial data update in the second half of 2026, subject to patient enrollment.

SGT-212