---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-020343"
form_type: "8-K"
ticker: "TSHA"
cik: "0001806310"
company_name: "Taysha Gene Therapies, Inc."
filed_at: "2023-01-31T23:59:59+00:00"
generated_at: "2026-06-20T05:36:27.136152+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Taysha receives FDA feedback on TSHA-120 GAN; sets Rett syndrome milestones for 2023

## Summary
- FDA acknowledged MFM32 as acceptable endpoint; recommended double-blind placebo-controlled design for TSHA-120 BLA.
- Dosing of first adult Rett patient with TSHA-102 expected H1 2023; initial clinical data also in H1 2023.
- CTA submission to UK MHRA for pediatric Rett syndrome expected mid-2023; IND to FDA planned H2 2023.
- Operational, structural and personnel changes implemented following business review to enhance execution.

## SEC filing metadata
- accession: 0001193125-23-020343
- form_type: 8-K
- ticker: TSHA
- cik: 0001806310
- company_name: Taysha Gene Therapies, Inc.
- filed_at: 2023-01-31T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- 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/1806310/000119312523020343/0001193125-23-020343-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1806310/000119312523020343/d427060d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-020343
- JSON: https://secwatch.observer/filing/0001193125-23-020343.json
- Plain text: https://secwatch.observer/filing/0001193125-23-020343.txt

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