Solid Biosciences Announces European Commission Orphan Designation for SGT-212 and Continued Progress in the FALCON Trial in Friedreich’s Ataxia
Globe Newswire•26/10/2026•08:00 ET
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Key Highlights
- ➤European Commission grants SGT-212 Orphan designation for Friedreich’s ataxia
- ➤Five participants dosed in Phase 1b FALCON trial as of October 5, 2026
- ➤No treatment-related serious adverse events observed among dosed participants
- ➤Solid expects initial FALCON clinical data in Q1 2027
Expert Statements
Jessie Hanrahan, Chief Regulatory & Preclinical Operations Officer at Solid Biosciences
“For families affected by Friedreich’s ataxia, the need for new treatment options remains significant, and this designation supports the continued development of SGT-212 globally as we advance a therapy intentionally designed for the unique challenges of FA”
Jessie Hanrahan, Chief Regulatory & Preclinical Operations Officer at Solid Biosciences
“With five participants now dosed in the FALCON trial, we continue to build clinical experience with this first-in-class, dual-route approach and look forward to reporting initial clinical data in the first quarter of 2027.”
- Obtaining Orphan designation from the European Commission reflects Solid’s commitment to the global development of SGT-212 for individuals living with Friedreich’s ataxia -
- SGT-212 is a first-in-class dual route FA gene therapy designed to combine direct, MRI-guided delivery to the dentate nuclei with systemic delivery to reach cardiac and other systemic tissues -
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