Taysha says Rett gene therapy manufacturing campaign met commercial criteria

Taysha Gene Therapies said it completed a manufacturing qualification campaign for TSHA-102, its investigational Rett syndrome gene therapy, meeting predefined product specifications and criteria comparing commercial product with clinical material. The campaign supports a planned biologics license application and potential inclusion of earlier Phase 1/2 trial data. The company reported no severe treatment-related serious adverse events or dose-limiting toxicities across its trials involving 33 participants as of the November 2026 data cutoff. All patients in the pivotal REVEAL and ASPIRE trials have been dosed and cleared acute safety monitoring. Taysha expects six-month interim results from the pivotal trial and FDA feedback on its application pathway in the first half of 2027.