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Solid Biosciences' SGT-212 Secures FDA Orphan Drug, Fast Track And Rare Pediatric Disease Designations; First Patient Dosed In Phase 1b FALCON Trial, Initial Data Expected H2 2026

Benzinga Newsdesk 9 months ago

BiotechNewsFDAGeneral

- SGT-212 has received FDA Fast Track, Rare Pediatric Disease and Orphan Drug designations -- Dosing of the first participant in the Phase 1b FALCON trial has been completed, with initial data expected in H2 2026,

- SGT-212 has received FDA Fast Track, Rare Pediatric Disease and Orphan Drug designations -

- Dosing of the first participant in the Phase 1b FALCON trial has been completed, with initial data expected in H2 2026, subject to participant enrollment -

CHARLESTOWN, Mass., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (NASDAQ:SLDB) (the "Company" or "Solid"), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to SGT-212 for the treatment of Friedreich's ataxia (FA). Additionally, earlier today, the Company reported that the first participant has been dosed in FALCON, a Phase 1b, first-in-human clinical trial evaluating SGT-212 for the treatment of FA.

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