Taysha Gene Therapies on Track to Complete TSHA-102 REVEAL and ASPIRE Dosing by Q2 2026
Taysha dosed multiple females 6-22 in its REVEAL trial and expects to complete REVEAL and ASPIRE dosing by Q2 2026 after FDA cleared ASPIRE in three 2-4-year-olds. As of March 2026 no treatment-related SAEs or DLTs were reported, and Taysha secured FDA alignment on a PPQ comparability plan for BLA.
1. REVEAL and ASPIRE Dosing Milestones
Taysha has dosed multiple females aged 6-22 in its single-arm REVEAL pivotal trial evaluating a high-dose intrathecal administration of TSHA-102. Enrollment is advancing across multiple sites and the company remains on track to complete dosing in both REVEAL and the three-patient ASPIRE trial by the end of Q2 2026.
2. FDA Regulatory Alignment
The company received FDA clearance to initiate ASPIRE in three patients aged 2 to <4 years with inclusion of at least three months of safety data in the planned BLA submission. Taysha also reached written alignment with the FDA on its PPQ and comparability strategy to leverage data across trials for commercial TSHA-102 manufacturing.
3. Favorable Safety Profile
As of the March 2026 data cutoff, TSHA-102 continues to show a favorable tolerability profile with no treatment-related serious adverse events or dose-limiting toxicities observed in both REVEAL Phase 1/2 and the REVEAL pivotal trials.