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confidence high
sentiment positive
materiality 0.75
Taysha reports new TSHA-120 data analysis supports FDA path; TSHA-102 first patient dosed
Taysha Gene Therapies, Inc.
- New TSHA-120 analysis shows 99% probability of slowing disease progression on mFARS and MFM32 Domain 3; FDA meeting expected Q3 2023.
- First adult patient with Rett syndrome dosed with TSHA-102 in REVEAL Phase 1/2 trial; safety/efficacy update expected early Q3 2023.
- CTA submission for TSHA-102 in pediatric Rett patients in UK mid-2023; IND submission to FDA H2 2023.
- Over seven years of safety data support TSHA-120; DPM using natural history data supports external control for regulatory path.