---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-219580"
form_type: "8-K"
ticker: "TSHA"
cik: "0001806310"
company_name: "Taysha Gene Therapies, Inc."
filed_at: "2023-08-24T23:59:59+00:00"
generated_at: "2026-06-11T04:16:40.861892+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Taysha Gene Therapies receives FDA Fast Track Designation for TSHA-102 in Rett syndrome

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-23-219580
- form_type: 8-K
- ticker: TSHA
- cik: 0001806310
- company_name: Taysha Gene Therapies, Inc.
- filed_at: 2023-08-24T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1806310/000119312523219580/0001193125-23-219580-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1806310/000119312523219580/d454718d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-219580
- JSON: https://secwatch.observer/filing/0001193125-23-219580.json
- Plain text: https://secwatch.observer/filing/0001193125-23-219580.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.