regulatory
confidence high
sentiment positive
materiality 0.65
Taysha Gene Therapies receives FDA Fast Track Designation for TSHA-102 in Rett syndrome
Taysha Gene Therapies, Inc.
- FDA granted Fast Track Designation for TSHA-102, an AAV9 gene therapy for Rett syndrome.
- TSHA-102 also holds FDA Orphan Drug and Rare Pediatric Disease designations plus EU Orphan Drug.
- Phase 1/2 REVEAL adult trial ongoing in Canada; second adult patient expected in current quarter.
- FDA cleared IND for pediatric patients; first pediatric dose expected Q1 2024.