Solid Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to SGT-212, its investigational gene therapy for the treatment of Friedreich’s ataxia $(FA)$. SGT-212 has also received FDA Fast Track and Rare Pediatric Disease designations. The company has initiated dosing of the first participant in the Phase 1b FALCON clinical trial, with initial data expected in the second half of 2026, pending participant enrollment. SGT-212 utilizes a dual-route administration approach designed to address the neurologic, cardiac, and systemic manifestations of FA.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Solid Biosciences Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9623584-en) on January 12, 2026, and is solely responsible for the information contained therein.