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Taysha Gene Therapies advances Rett syndrome gene therapy, on track for FDA approval submission in 2026

Company Fundamentals
06 May 2026
GlobeNewsWire
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Bullish
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Taysha Gene Therapies reported progress in its TSHA-102 gene therapy for Rett syndrome, reaffirming FDA alignment on trial design and potential approval based on a six-month interim analysis from the REVEAL pivotal trial. The company is advancing dosing in the REVEAL and ASPIRE trials, expecting to complete dosing by Q2 2026, with longer-term safety and efficacy data due soon. TSHA-102 continues to show a favorable safety profile with no serious adverse events related to treatment. Financially, Taysha posted a net loss of $42.4 million for Q1 2026 but holds $276.6 million in cash, sufficient to fund operations into 2028. The company plans to complete a BLA-enabling manufacturing campaign by Q4 2026 and aims for regulatory submission based on ongoing trial data.

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