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Taysha Gene Therapies Advances TSHA‑102 Rett Syndrome Program; First Patient Dosed In REVEAL Pivotal Trial, FDA Alignment On ASPIRE Safety Data For Broad BLA, Dosing Completion Expected Q2 2026 With Longer‑Term Data Update In H1 2026

Benzinga·01/06/2026 13:12:39
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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

DALLAS, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (NASDAQ:TSHA) (Taysha or the Company), a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today announced progress across the TSHA-102 pivotal program, an intrathecally (IT) delivered AAV9 gene therapy with disease modifying potential, in clinical evaluation for the treatment of Rett syndrome.