Taysha Gene Therapies (TSHA) announced details of its planned pivotal Part B trial design for TSHA-102 following written alignment from the FDA. Additionally, the company announced clinical data from Part A of the REVEAL Phase 1/2 adolescent/adult and pediatric trials evaluating TSHA-102 in Rett syndrome. The alignment reached with the FDA was supported by the company’s analysis of the International Rett Syndrome Foundation’s longitudinal Rett syndrome natural history study data, as well as clinical data from the ongoing REVEAL Phase 1/2 trials.
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