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 Newsdesk 10 months ago
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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 sitesReached written alignment with FDA on inclusion of ≥3 months of
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.