Taysha Gene Therapies: TSHA-102 gets FDA Breakthrough Therapy, Q3 net loss $32.7M

Taysha Gene Therapies, Inc.

FDA granted Breakthrough Therapy designation for TSHA-102 in Rett syndrome; FDA alignment finalized on REVEAL pivotal trial protocol with 6-month interim analysis to expedite BLA.
First patient dosing in REVEAL pivotal trial scheduled Q4 2025; enrollment to continue at multiple sites.
Regained full unencumbered rights to TSHA-102 after Astellas option agreement expired in October 2025.
Q3 2025 net loss $32.7M ($0.09/share); R&D $25.7M; cash $297.3M expected to fund operations into 2028.
David McNinch appointed Chief Commercial Officer in September 2025; TSHA-102 generally well tolerated with no treatment-related SAEs in 12 patients.

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