Taysha reports FDA-aligned pivotal trial for TSHA-102; 100% of Part A patients gained milestones

Taysha Gene Therapies, Inc.

FDA aligned on single-arm pivotal Part B trial (N=15) for TSHA-102 in Rett syndrome patients ≥6 years; primary endpoint: developmental milestone gain/regain.
Part A: 100% (10/10) of patients aged 6-21 gained ≥1 milestone; high dose showed faster and deeper effects vs low dose.
Natural history data (~1,100 patients) showed ~0% likelihood of milestone gain/regain after age 6, supporting trial design.
No treatment-related SAEs or DLTs; all related AEs mild-to-moderate across 12 patients.
Company suspended $100M ATM prospectus; Sales Agreement remains in effect; new prospectus required for future sales.

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