Jan. 7 at 1:30 AM
$TSHA 💥🚀💰💰💰
- First patient dosed in REVEAL pivotal trial evaluating TSHA-102 (N=15, aged 6 to <22 years) in Q4 2025, with enrollment advancing across multiple sites
- Reached written alignment with FDA on inclusion of ≥3 months of safety data from ASPIRE trial evaluating TSHA-102 (N=3, aged 2 to <4 years) in planned BLA submission to support a broad label in patients aged ≥2 years with Rett syndrome
- Completion of dosing in REVEAL pivotal trial and ASPIRE trial expected in Q2 2026
- Longer-term safety and efficacy data update from Part A of REVEAL Phase 1/2 trials expected in H1 2026